Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: VA Office of Research and Development

Bright Light Therapy for residual 
daytime symptoms associated with 
obstructive sleep apnea
NCT04299009
November 11, 2020

Date: Monday, November 9, 2020 2:28:59 PM
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ID: Pro00003376
View: 0.0 Type of Submission Entry
Study Identification Information
This is the first step in your Human Research Application.  You will automatically be guided to the 
appropriate forms needed to complete your submissions.
1.0
* Study Name:
Bright Light Therapy for Residual Daytime Symptoms Associated with Obstructive Sleep Apnea 
(Bright DayS)
2.0
* Brief Description (using layman's terms) - 500 words or less:
Persistent daytime symptoms of sleepiness in individuals with obstructive sleep apnea (OSA) who 
are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term 
medical and functional outcomes. Supplementary exposure to bright light has beneficial effects on 
sleep quality and daytime vigilance in healthy individuals and it has been increasingly applied in a 
variety of sleep and neuropsychiatric conditions. This study will explore the role of Bright Light 
Therapy (BLT), a well-established non-pharmacological intervention for circadian disturbances, for 
the treatment of residual daytime symptoms of OSA which do not respond to CPAP. BLT will be 
delivered via therapy glasses in a cross-over design, where each participant will be exposed to 
active treatment and sham treatment (4 weeks in each arm) in a randomized order. The 
hypothesis is that participants will demonstrate improvements in the variables of interest during 
the four-week active treatment portion of the eight-week crossover study, compared to the four-
week sham treatment portion. We will collect qualitative data from participants regarding the 
feasibility and acceptability of BLT to guide future testing and implementation of treatment. 
3.0
* Is this research study a Greater than Minimal Risk Clinical Trial?
Yes 
No
4.0
* Is this study a Greater than Minimal Risk Comparative Effectiveness research?
Yes 
No
5.0
* Principal Investigator:
Isabella Soreca
  5.1
* VA hours per week the PI is devoted to project:
8
  5.2
* Is the PI working with ionizing radiation?
Yes 
No
  5.3
* Is the PI working with biological hazards?
Yes 
No
  5.4
* Is the PI shipping biological hazards?
Yes 
No
A completed and signed Research Financial Conflict of Interest Statement is required for all 
investigators (including Principal Investigators, Co-Principal Investigators, and Co-
Investigators) listed on the study application. Financial Conflict of Interest Form-Nov. 
2013
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5.5
Upload Financial Conflict of Interest Statement:
Soreca FCOI(0.01)
6.0
Research Staff:
Researcher
Role in 
Project
Hours per 
Week 
devoted to 
project
Administer 
Informed 
Consent
Working 
with 
Ionizing 
Radiation
Working with 
Biologicial 
Hazards?
Shipping 
biological 
hazards?
FCOI 
Form
Joseph 
Mikolic
Research 
Staff
2
no
no
no
no
Nicole 
Arnold
Coordinator
10
yes
no
no
no
Jodilyn 
Roberts
Coordinator
5
yes
no
no
no
Hanna 
Edvardsson
Coordinator
5
yes
no
no
no
Monique 
Kelly
Research 
Staff
2
no
no
no
no
7.0
Type of Submission:
Description
This is a new study. This has not previously been submitted to the IRB.
This is a new paper conversion. This study has been previously approved by the IRB.
If this is a 'New Paper Conversion' please include the MIRB Number:
Please upload a letter certifying that you have made no modifications or amendments in 
converting this research study from paper to electronic:
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ID: Pro00003376
View: 1.0 Study Identification Information
Study Identification Information (Continued)
1.0
* Do you certify that all research staff administering informed consent are 
knowledgeable about the study?
yes 
2.0
* To the best of your knowledge do you, or any member of your research staff, have any 
potential, actual or perceived conflict of interest of a professional or personal nature 
that may affect any aspect of the research, including, but not limited to, the review 
and/or conduct of this study?
Yes 
No
If yes, provide a description, including name of study team member with conflict:
3.0
* Qualifications of the Investigators:
Dr Soreca is board certified in Psychiatry and Sleep medicine and has extensive experience in 
conducting research with OSA patients.
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ID: Pro00003376
View: 1.2 VA Involvement
VA Involvement
1.0
Does the proposed research involve any of the following?:
Name

VA Funding

VA Personnel Funded Effort

VA Patients or their Private Health Information
Other VA Resources: Central IRB

Other VA Resources: VA Equipment

Other VA Resources: VA Property (Including space leased to, or used by VA)

Other VA Resources: VA Databases
None of the Above apply to this research
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ID: Pro00003376
View: 1.3 Study Funding Information
Study Funding Information
1.0
* Funding Sources:
Funding Source
(Other)
Code
View Rehabilitation R&D (Prog 822)
9022
2.0
Upload Grant Application, if applicable (If NIH, VA, voluntary agency, must upload):
Name
Modified Date
Grant Application proposal
12/16/2019 1:26 PM
DMAP plan
3/26/2020 7:42 AM
Human SUbjects Plan
3/26/2020 7:42 AM
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ID: Pro00003376
View: 1.4 Resources
1.0 
* Do you currently have adequate resources (e.g., staff, physical space, information 
technology, etc.) to protect the safety of participants, staff, and the confidentiality of 
subjects’ data during the conduct of this study?
Yes
No
If yes, include a listing of the VAPHS resources that will be used for this study and are 
necessary to protect participants. 
Letters of support have been requested from the following service lines: Sleep Clinic and 
StatCore.
Additionally, there is an adequate number of qualified staff - coordinator(s), adequate time for 
the researcher to conduct and complete the research, access to a population (both the PI's 
clinic and Sleep Clinic) that will allow recruitment of the necessary number of participants, 
space and facilities needed to properly conduct the study and data core through StatCore 
support as applicable.
If no, please describe the resources that will be needed and explain how the resources will be 
obtained before the study is initiated:
2.0 
* VAPHS requires that either the PI or co-PI have a physical presence at VAPHS. 
Please describe the role the PI and/or co-PI have at VAPHS with respect to clinical 
responsibilities or in relation to other research activities.
The PI has a physical presence at VAPHS which includes various clinical duties.
Additionally, there is an adequate number of qualified staff - coordinator(s), adequate time for 
the researcher to conduct and complete the research, access to a population (both the PI's 
clinic and Sleep Clinic) that will allow recruitment of the necessary number of participants, 
space and facilities needed to properly conduct the study and data core through StatCore 
support as applicable
3.0 
* Will off-site ancillary service facilities (e.g., radiology services, central labs, non VA 
space, etc) be used for this study?
Yes 
No
If yes, please provide the location and a brief description of the project activities to be 
conducted at the off-site ancillary facilities:
4.0 
* Will a firm be contracted to obtain consent from subjects, collect private 
individually identifiable information from human subjects, or be involved in activities 
that would institutionally engage the firm in human subjects’ research?
Yes 
No
If yes, please provide a description of the contracted service(s):
* Please specify the IRB that has oversight of the firm's activity(ies):
Name of Site / Institution
IRB Approval Document
FWA Number
There are no items to display
5.0
Collaborations
Please list any non-VAPHS institutions or individuals (i.e. co-authors, mentors, etc.) that you 
will collaborate with and describe their specific role in the research:
Dr. Helen Burgess, consultant on this study, is an expert in human circadian rhythms and 
bright light therapy. As a consultant on this study, she will offer guidance to the study staff on 
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the implementation of all aspects of BLT treatment and treatment adherence tracking. 
She is at the University of Michigan and has been PI on studies using the Re-timer glasses. And 
she will offer technical and scientific guidance, but no access to individual patient data.
5.1
If this is not Multi-Site Research, please upload the appropriate written agreement(s) here:
Name
There are no items to display
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ID: Pro00003376
View: 1.5 Project Information
1.0 
Does the project involve any of the following (check all that apply):
Type
Biological Hazards (including human biological specimens)
Chemicals 
Ionizing radiation or use of radioactive materials 
Drug, Biological, or Nutritional (e.g. herbal or dietary) Supplement
2.0 
Project Focus (check if applicable):
Type
Traumatic Brain Injury (TBI)
Post Traumatic/Post Deployment Stress Disorder (PTSD/PDSD)
Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)
3.0 
KEYWORDS
Please provide a minimum of 3, maximum of 6 keywords.  Please use MeSH terms.
* OSA (obstructive sleep apnea)
* BLT (bright light therapy)
* depression
4.0
* Please describe the type of study:
Randomized, single-blind, crossover, placebo-controlled study of bright light therapy glasses.
5.0
* Will any of the research being conducted as a part of this study be used to fulfill 
academic requirements (e.g., master’s thesis, dissertation, or other academic 
program requirements necessary to obtain a degree/certification, etc.)?
Yes 
No
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ID: Pro00003376
View: 1.6 (CR) Study Locations
Study Locations
1.0
* Please add the local sites where this study will be conducted:
Location
View VAPHS University Drive Division
If Other, Please Specify:
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ID: Pro00003376
View: 1.6.1 (CR) Multi-Site Study
1.6.1 Multi-Site Study
1.0
* Is this a multi-site study:
Yes 
No
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ID: Pro00003376
View: 1.7 Section Chief and Service Line VP approvals
Please upload the approval of the Section Chief, if applicable and the Service Line VP.
1.0 
* Institutional Approval Document:
Institutional Approval Page(0.01)
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ID: Pro00003376
View: 2 Study Objectives & Design
Study Summary
1.0
Funding End Date:
3/31/2022
2.0 
* Abstract.  Please provide a brief description of the study.
Sleep apnea is one of the most common chronic condition among US military veterans1, 
causing sleepiness, reduced psychomotor vigilance and depression, which undermine 
daytime functioning and quality of life 2 3. Persistent daytime symptoms of sleepiness in 
individuals with OSA who are using Continuous Positive Airway Pressure (CPAP) are 
associated with adverse long term medical and functional outcomes 4 5 6 7 8. Preliminary 
studies in humans and animal models have shown persisting alterations of circadian 
rhythms in OSA patients 12 13, that fail to normalize with CPAP treatment 14. CPAP 
treatment, while effective at correcting respiratory events and night time blood 
oxygen saturation levels, does not necessarily re-align the circadian system. 
Supplementary exposure to bright light has beneficial effects on sleep quality and daytime 
vigilance in healthy individuals and it has been increasingly applied in a variety of sleep and 
neuropsychiatric conditions15 16 17. However, no study to date has tested the application of 
BLT to treat daytime symptoms associated with sleep apnea. Our study will be the first to 
explore the role of Bright Light Therapy (BLT), a well-established non-pharmacological 
intervention for circadian disturbances, for the treatment of residual daytime symptoms of 
OSA which do not respond to CPAP. 
Background and Significance:
Excessive daytime sleepiness and depression in OSA and the role of CPAP therapy: OSA 
is characterized by repeated pharyngeal obstruction during sleep, causing airflow cessation or 
reduction and resulting in fragmented sleep, hypoxia and sympathetic hyperarousal. This 
constellation of physiological processes often leads to immediate and long term consequences, 
such as reduced daytime vigilance, sleepiness and fatigue, depressed mood, leading to disability, 
functional impairment 18, reduced quality of life and increased morbidity and mortality119 18 20 21. 
Although Excessive Daytime Sleepiness (EDS) is considered the cardinal symptom of sleep apnea, 
it is only weakly associated with other markers of OSA severity, such as Apnea-Hypopnea Index 
(AHI), nocturnal blood oxygen saturation levels and arousals 22 23 24 25 26. Several randomized 
controlled trials have established continuous positive airway pressure (CPAP) efficacy regarding 
sleepiness in OSA 5 27 28. However, residual excessive sleepiness (RES) in patients correctly 
treated with CPAP occurs in more than 12% of patients 4 and is associated with increased risk of 
depression29 30, with up 42 % of OSA patients experiencing persistent depressive symptoms after 
1 year of CPAP therapy 6 . In summary, sleepiness and depression are clinical indicators of 
increased risk of adverse health outcomes and diminished quality of life in OSA, their 
manifestation is weakly correlated with the severity of OSA and they are sometime not resolved 
by adequate CPAP treatment.
Effects of Bright Light on circadian systems, mood and sleepiness: Environmental light is 
the strongest synchronizer for the circadian system, and its phase-resetting properties are thought 
to mediate its biological effects on mood and cognitive functions. These effects are best 
reproduced by artificial light encompassing the green-blue portion of the spectrum (450-500 nm), 
which is responsible for the phase-shifting properties on the circadian system 33. Several studies 
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have demonstrated that short amounts (30-60 minutes) of daily light therapy in the morning 
effectively realigns individuals’ circadian rhythms, leading to improvements in sleep duration, self-
reported sleep quality, insomnia symptoms and fatigue 15. There is robust evidence that light is 
effective in acutely decreasing sleepiness and fatigue 34 35 and increasing alertness 36 37 38. 
Moreover, light therapy is used alone or as adjuvant therapy in a growing number of psychiatric 
and neurodegenerative diseases, where alterations of sleep-wake cycles are often observed 39.. 
Despite the amounting evidence of the benefits of BLT for a number of symptoms and functional 
domains affected in patients with OSA, no study to date has explored its role for patients with 
sleep apnea.
Design Overview: This is a feasibility study for a within-subjects cross-over trial: eligible 
participants will undergo baseline assessments over one week, during which baseline measures, 
including actigraphy, will be collected. They will subsequently be randomized to one of two 
treatment sequences Bright Light Therapy-Sham Bright Light Therapy (BLT-sBLT) or sBLT-BLT for 
the total duration of 9 weeks (4 weeks in each treatment arm, plus one week of “wash-out period 
in between treatments). To avoid subjects potential awareness of placebo treatment (differences 
in light intensity between the active and sham treatment cannot be completely eliminated), 
subjects will be told that the study will test the effects of two different light intensities on the 
target symptoms. Participants will undergo a further final assessment at week 12, 4 weeks after 
completion of the treatment.
3.0
* Describe the study objectives. Please include primary aim and hypothesis, if applicable 
any secondary aims and hypotheses. 
SA1: to test the feasibility of Bright Light Therapy (BLT) to ameliorate sleep related functional 
impairment in CPAP-treated individuals with OSA. Hypothesis: BLT, delivered via therapy glasses, 
will have high rates of acceptance and adherence among Veterans with OSA who still experience 
residuals symptoms, despite adequate treatment with CPAP. We will use a cross-over design, 
where each participant will be exposed to active treatment and sham treatment in a randomize 
order. We will collect qualitative data from participants regarding the feasibility and acceptability 
of BLT to guide future testing and implementation of treatment. SA2 (exploratory): to test the 
effects of bright light therapy on sleep related functional impairment, quality of life and CPAP-
resistant symptoms of sleepiness and depression. Hypothesis: participants will demonstrate 
improvements in the variables o interest during the four-week active treatment portion of the 
eight-week crossover study, compared to the four-week sham treatment portion. We will also be 
able to detect potential treatment carryover effects and inform design decisions for a subsequent 
larger study.SA3 (exploratory): to test whether the degree of circadian rhythms regularity 
(marker of re-alignment) during BLT mediates the effects of BLT on CPAP-resistant symptoms. 
Hypothesis: the effect of BLT on CPAP resistant daytime symptoms will be exerted through 
increased regularity of circadian rhythms, assessed via actigraphy. At the completion of this 
project, we will have generated preliminary data critical to the design and implementation of a 
larger trial investigating the impact of BLT on CPAP-resistant symptoms of sleepiness and 
depression, leading to increased functional impairment in OSA patients. If proven effective, this 
intervention has the potential to improve the lives of many Veterans suffering from OSA who do 
not find full symptomatic relief with CPAP, by offering a non-pharmacological intervention that is 
safe, relatively inexpensive and whose implementation demands only a minimal degree of 
behavioral modification on the patient.
4.0
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* Provide a summary of the background of the study, and explain how this research will 
contribute to existing knowledge.  Describe previous studies that provides a basis to 
show that the proposed research can be carried out without undue risk to human 
subjects.  
Excessive daytime sleepiness and depression in OSA and the role of CPAP therapy: OSA 
is characterized by repeated pharyngeal obstruction during sleep, causing airflow cessation or 
reduction and resulting in fragmented sleep, hypoxia and sympathetic hyperarousal. This 
constellation of physiological processes often leads to immediate and long term consequences, 
such as reduced daytime vigilance, sleepiness and fatigue, depressed mood, leading to disability, 
functional impairment 18, reduced quality of life and increased morbidity and mortality119 18 20 21. 
Although Excessive Daytime Sleepiness (EDS) is considered the cardinal symptom of sleep apnea, 
it is only weakly associated with other markers of OSA severity, such as Apnea-Hypopnea Index 
(AHI), nocturnal blood oxygen saturation levels and arousals 22 23 24 25 26. Several randomized 
controlled trials have established continuous positive airway pressure (CPAP) efficacy regarding 
sleepiness in OSA 5 27 28. However, residual excessive sleepiness (RES) in patients correctly 
treated with CPAP occurs in more than 12% of patients 4 and is associated with increased risk of 
depression29 30, with up 42 % of OSA patients experiencing persistent depressive symptoms after 
1 year of CPAP therapy 6 . In summary, sleepiness and depression are clinical indicators of 
increased risk of adverse health outcomes and diminished quality of life in OSA, their 
manifestation is weakly correlated with the severity of OSA and they are sometime not resolved 
by adequate CPAP treatment.
Effects of Bright Light on circadian systems, mood and sleepiness: Environmental light is 
the strongest synchronizer for the circadian system, and its phase-resetting properties are thought 
to mediate its biological effects on mood and cognitive functions. These effects are best 
reproduced by artificial light encompassing the green-blue portion of the spectrum (450-500 nm), 
which is responsible for the phase-shifting properties on the circadian system 33. Several studies 
have demonstrated that short amounts (30-60 minutes) of daily light therapy in the morning 
effectively realigns individuals’ circadian rhythms, leading to improvements in sleep duration, self-
reported sleep quality, insomnia symptoms and fatigue 15. There is robust evidence that light is 
effective in acutely decreasing sleepiness and fatigue 34 35 and increasing alertness 36 37 38. 
Moreover, light therapy is used alone or as adjuvant therapy in a growing number of psychiatric 
and neurodegenerative diseases, where alterations of sleep-wake cycles are often observed 39.. 
Despite the amounting evidence of the benefits of BLT for a number of symptoms and functional 
domains affected in patients with OSA, no study to date has explored its role for patients with 
sleep apnea.
5.0 
* Describe the overall significance of the research in terms of the problem to be studied 
and potential findings, as well as its relevance to the care of veterans, the VAPHS, and 
the VHA:
US military service members and veterans have experienced an increased in the prevalence of 
sleep apnea, recently reaching epidemic proportions 
1 40, with rates that exceed those reported for 
the civilian population. OSA with associated EDS is known to cause significant work disability 
41, 
and EDS contributes to the burden of illness by driving increased rates of depression, lower quality 
of life and greater impairment in productivity 
42. Failure to achieve symptomatic recovery with 
current treatments can have detrimental effects on the health and quality of life of our Veterans. 
The treatment proposed in this pilot study has been showed to be safe, inexpensive, and 
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potentially effective for the very cluster of symptoms that cause the morbidity and impairment in 
individuals with OSA
6.0
Please upload any additional documents:
Name
Version
There are no items to display
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ID: Pro00003376
View: 2.1 Required Reviews
Required Reviews
1.0
Type of Submission:
New study 
If this is a 'New Paper Conversion' please include the MIRB Number:
Please upload a letter certifying that you have made no modifications or amendments in 
converting this research study from paper to electronic:
2.0
* Requested Review Type:
Name
Exempt
Expedited
Full IRB Review
Not Human Subject Research
3.0 
Please check which of the following Service 
Lines/Departments/Entities
will be impacted or used in the conduct of this study
Upload Letter 
of Support
Clinical Support

Medical Specialty
Sleep Clinic LOS
(0.01)
Investigational Drug Service
Imaging
Community Based Care
Patient Care Services
Behavioral Health
Primary Care
Surgical Specialty
Critical Care
Clinical Trials Center
Regulatory Coordinator Support Core
Clinical Coordinator 
Support Core
 Ancillary Support Core
 Data Support Core
Research Registry
Registry Number:

Other
StatCore LOS(0.01)
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If Other, please specify:
StatCore 
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ID: Pro00003376
View: 2.1.1 Expedited Qualification
REQUEST FOR EXPEDITED REVIEW 
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not 
greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine 
physical or psychological examinations or tests.
AND 
Identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil 
liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, 
or reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach 
of confidentiality are minimal.
1.0 
* Please certify that ALL of the following are true:
Case
Research presents no more than MINIMAL RISK to subjects (considering physical, psychological, 
social, legal and economic risk)
Identification of the subjects and/or their responses WOULD NOT reasonably place them at risk of 
criminal or civil liability or be damaging to the subject’s financial standing, employability, 
insurability, reputation, or be stigmatizing, OR reasonable and appropriate protections will be 
implemented so that risks related to invasion of privacy and breach of confidentiality are minimal.
The research is not classified.
The research involves only procedures listed in one or more of the categories listed in Section 2.
2.0
If you check any of the items below, the study is qualified for EXPEDITED review status 
under federal guidelines.
* Select all that apply:
Description

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is 
met: 
(a) Research on drugs for which an investigational new drug application (21 CFR 
Part 312) is not required.
(b) Research on medical devices for which an investigational device application (21 
CFR 812) is not required OR the medical device is cleared/approved for marketing 
and the medical device is being used in accordance with its cleared/approved 
labeling. 
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) From healthy, non-pregnant adults who weigh at least 110 pounds. [not to exceed 550 
ml in an 8 week period and collection may not occur more frequently than 2 times per week; 
or
(b) From other adults and children, considering the age, weight and health of the subjects, 
the collection procedure, the amount of blood to be collected: The amount drawn may not 
exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur 
more frequently than 2 times per week. 
3. Prospective collection of biological specimens for research purposes by non-invasive 
means.
Examples:
(a) hair and nail clippings in a nondisfiguring manner;
(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for 
extraction;
(c) permanent teeth if routine patient care indicates a need for extraction;
(d) excreta and external secretions (including sweat);
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Description
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing 
gumbase or wax or by applying a dilute citric solution to the tongue;
(f) placenta removed at delivery;
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
(h) supra- and subgingival dental plaque and calculus, provided the collection procedure is 
not more invasive than routine prophylactic scaling of the teeth and the process is 
accomplished in accordance with accepted prophylactic techniques;
(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth 
washings;
(j) sputum collected after saline mist nebulization.

4. Collection of data through noninvasive procedures (not involving general 
anesthesia or sedation) routinely employed in clinical practice, excluding 
procedures involving x-rays or microwaves. Where medical devices are used, they 
must be cleared/approved for marketing. (Studies intended to evaluate the safety 
and effectiveness of the medical devices are not generally eligible for expedited 
review, including studies of cleared medical devices for new indications) 

5. This research involves materials (data, documents, records, or specimens) that 
have been collected for any purpose including previous research or will be collected 
solely for nonresearch purposes (such as medical treatment or diagnosis).
6. This research involves the collection of data from voice, video, digital, or image recordings 
made for research purposes.

7. This research will be performed on individual or group characteristics or behavior 
(including, but not limited to, research on perception, cognition, motivation, 
identity, language, communication, cultural beliefs or practices, and social 
behavior) or will employ a survey, interview, oral history, focus group, program 
evaluation, human factors evaluation, or quality assurance methodologies. 
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ID: Pro00003376
View: 3 Research Design
Methods & Procedures 
1.0 
* Does this research study involve any of the following: 
Name

Deception
Interview/Focus Groups
Use of Drug, biological, or nutritional (e.g., herbal or dietary) supplement (investigational or 
FDA approved)?

Use of medical devices
Prospective Analysis of Specimens
Banking of Specimens-Data
Retrospective use of specimens
Audio/Video Recordings or Photographs 
Honest Broker or other similar service
None of the Above
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ID: Pro00003376
View: 3.1 Deception
Deception
1.0
* Describe the information that will be withheld from, or misinformation that will be 
provided to subjects, and the justification.
Participants will be randomized to one of two treatment sequences; Bright Light Therapy-Sham 
Bright Light Therapy (BLT-sBLT) or sBLT-BLT for the total duration of 9 weeks (4 weeks in each 
treatment arm, plus one week of “wash-out period in between treatments). To avoid subjects 
potential awareness of placebo treatment (differences in light intensity between the active and 
sham treatment cannot be completely eliminated), subjects will be told that the study will test the 
effects of two different light intensities on the target symptoms. 
If they were told that one treatment sequence was a placebo prior to participation, they would 
certainly notice the difference and likely not evaluate the effects of the two 4-week spectrums 
objectively.
There is no additional risk in either arm of the study. 
2.0
* Describe the plans for de-briefing the subjects after their participation.
The plan for debriefing subjects is to do so following their participation. That can be either once 
they complete the study or if they withdraw prior to full completion. A debriefing statement is 
written and will be both discussed with the subject and given to them as a hard copy.
3.0
* Attach Debriefing Statement:
Debriefing statement(0.01)
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ID: Pro00003376
View: 3.4 Use of Medical Devices
Medical Devices
1.0
* Specify all devices used on this study:
Device 
Name
Manufacturer Use of Device
IDE 
Number(if 
Applicable)
Device 
Brochure Description of Use
Risk Level 
Determined 
by Sponsor
ActiWatch Respironics
FDA Approved 
Device used in 
approved 
manner
ActiWatch 
brochure
(0.01)
The VA Sleep Clinic has 
a license for use of this 
device. The participant 
will be asked to wear a 
wrist actigraph. This is a 
small device that they 
wear on their wrist like a 
watch. The actigraph 
measures body 
movement, and helps us 
to see patterns of sleep, 
wakefulness, and 
activity. It is to be worn 
during the entire 9 
weeks of the study. It 
can be worn while they 
sleep as well as when 
showering. 
Non-
Significant 
Risk
Re-timer 
bright 
light 
therapy 
glasses
Re-timer
Investigational 
Device Not Yet 
Approved for 
use
ReTimer 
glasses 
brochure
(0.01)
The FDA has guidelines 
regarding the use of 
non-prescription 
sunglasses available for 
review. Bearing in mind 
that the device being 
used in this study are 
not sunglasses, we will 
refer to these guidelines 
in answering the 
comment as to why an 
IDE is not necessary. 
These glasses are 
commercially available 
and in use by the 
general population. They 
can be purchased online. 
This agrees with the 
guidelines stating that it 
is “…marketed directly 
to the end user (i.e., 
consumer) without the 
need for a prescription 
or any other order 
issued by a licensed 
eyecare practitioner….” 
Also that they are”… 
Nonprescription devices 
are commonly sold or 
distributed as "over-the-
counter" (OTC) devices.” 
Finally, they meet 
international UV and 
blue light safety 
standards, they are 
brighter than most 
Non-
Significant 
Risk
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Device 
Name
Manufacturer Use of Device
IDE 
Number(if 
Applicable)
Device 
Brochure Description of Use
Risk Level 
Determined 
by Sponsor
indoor lighting but 
dimmer than outdoor 
light on a bright day."
2.0
* Describe your plan for storage and control of devices:
ActiWatch (actigraphy) will be dispensed following ICF and worn for 1 week. 
Following the 1 week assessment period subjects will return actigraph, and received a newly 
charged actigraph and the BLT glasses. The newly dispensed actigraph will be worn the remainder 
of the study, i.e. 9 weeks.
The BLT glasses will be worn for 4 weeks followed by a 1-week washout period and then another 4 
weeks. 
Study Bright light glasses and ActiWatches will be stored in a locked cabinet in the Research Office 
Building. 
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ID: Pro00003376
View: 4 Research study methods
Research Study Methods
Describe all study related procedures following enrollment of a subject in this study.
Please see Section 6 for where the study team defines when a subject will be considered enrolled in the 
study.
1.0 
* Research Procedures/Interventions:
At the time of the on-site evaluation, a member of the study staff will obtain written informed 
consent and the study coordinator will administer study questionnaires and instruct subjects to 
wear the actigraph and complete a sleep diary for one week. If the participant is enrolling 
remotely, remote consent will be obtained over the phone and study materials, including an 
information sheet, the actigraph and sleep diary, will be mailed to the participant. At the end of 
the baseline assessment week, participants will return the actigraph and sleep log and will 
complete study questionnaires. Research staff will download actigraphy data and determine the 
time for administration of BLT based on habitual wake up time (average wake up time for 
baseline week). Participants will then be given a newly charged actigraph to wear for the 
following 4 weeks and the BLT glasses in person or mailed to them if they are doing visits 
remotely.
The intervention will consist of four weeks of BLT via therapy glasses (RetimerLTD), and four 
weeks of sBLT, in randomized order, spaced out by a one-week wash-out (i.e. no treatment) 
period, to minimize carry-over effects. The sham treatment will be delivered using the same 
therapy glasses used for active treatment, by applying a neutral density filter film on the LED 
light, thus blocking 85% of the blue-green wavelength light. To avoid subjects potential 
awareness of placebo treatment (differences in light intensity between the active and sham 
treatment cannot be completely eliminated), subjects will be told that the study will test the 
effects of two different light intensities on the target symptoms. This is "deception" in that if 
the subjects were told there was a placebo treatment and a study treatment they would be 
able to discern the difference therefore they are being told there are 2 types of light instead in 
order to preserve the blind. Subjects will be instructed to self-administer light therapy at home 
using study-provided BLT glasses for 60 min each morning at the prescribed time (derived 
from habitual wake up time) during a period of 8 weeks. After the first 4 weeks, they will bring 
their equipment in and it will be altered to either active or sham treatment. During the light 
therapy subjects can engage in other activities such as reading or having breakfast, but will be 
told not to shower with the therapy glasses on. They will also be instructed to remain indoors 
during the 60-minute treatment. Subjects will be given an alarm which has been pre-
programmed to go off at the BLT prescribed time unless they prefer to use their own alarm on 
their personal alarm clock or phone. Adherence will be monitored by fitting the therapy glasses 
with a light and motion sensor. They will be instructed to wear the wrist actigraph for the 
entire duration of the treatment. It will, however, be replaced at intervals along with the 
glasses to preserve battery life. Participants will undergo a further final assessment at week 
13, which is 4 weeks after completion of the treatment.
Please upload a table of procedures if applicable.
The study procedures table must be completed for: 
   - All Greater than Minimal Risk (GTM) studies; and 
   - All Minimal Risk studies that use Standard of Care or Usual Care/Interventions.
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Name
Modified Date
Table of Procedures
8/7/2020 3:00 PM
2.0 
* Will Usual Care Procedures/Interventions be used?"
Yes 
No
If yes, please specify and include a description of what the usual care or expected level of care 
is at VAPHS (e.g., medications, testing, timing, etc.) for patients, similar to those individuals 
that meet the inclusion/exclusion criteria for this research study:
2.1 
If Usual Care Procedures/Interventions will be used, who is the individual or entity responsible 
for relevant aspects of the usual care (i.e., which of the above usual care activities will the 
research study team be responsible for)?:
2.2 
Does the usual care at VAPHS for the condition of interest in this research study differ from 
national guidelines/recommendations (i.e. standard of care)?
Yes 
No
If yes, please describe the differences:
2.3 
Are any procedures that are considered standard for this patient population performed more 
frequently than usual care?
Yes 
No
If yes, please indicate which time points are considered usual care and which are considered 
research.
2.4 
If there is more than one standard, does VAPHS limit which one is followed (e.g. warfarin use 
for atrial fibrillation vs. one of the newer anticoagulants).
Yes 
No
If yes, please explain:
3.0 
* Does clinical expertise need to be enlisted?
Yes 
No
If yes, please provide the provisions for enlisting the services of a clinician with appropriate 
expertise and privileges to perform duties, if the investigator is not a clinician [i.e. reviewing 
the data, adverse events, and new study findings; also making required decisions to protect 
the health of the subject (e.g., stopping the participant’s involvement in the study or 
determining when to notify the subject or the subject’s health care provider of information that 
may affect the health of the subject)]:
4.0 
Please upload any surveys, questionnaires, and data collection forms.
Document
Description
Version Number
View Demographics basic.docx(0.01)
0.01
View Epworth Sleepiness scale(0.01)
0.01
View FOSQ-10(0.01)
0.01
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Document
Description
Version Number
View HRQOL.docx(0.01)
0.01
View Inclusion Exclusion Criteria.docx(0.02)
0.02
View Phone Call - Week 2.docx(0.01)
0.01
View Phone Call - Week 6.docx(0.01)
0.01
View QIDS-SR(0.01)
0.01
View sleepdiary_aasm.pdf(0.01)
0.01
View Visit 6 - Qualitative Interview Form.docx(0.01)
0.01
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ID: Pro00003376
View: 4.1 Research study methods: analysis Plan 
1.0 
* Please describe the analysis plan for the study (it is acceptable to refer to the 
sponsor/multi-site protocol for section if applicable):
Primary Data Analysis: We will use R version 3.4. SA1: To assess the feasibility of the current 
design to measure the effect of BLT on sleep related functional impairment in CPAP-treated 
individual with OSA. We will describe the following components of feasibility: recruitment and 
participant flow, adherence, data completeness and participant burden, and time course of 
treatment effects (e.g. do carry-over effects require a longer wash out period or suggest that a 
two-arm between-subject RCT design would be more appropriate?). Our main outcome 
analyses will employ multi-level linear mixed models with sleep related functional impairment 
and depression as the dependent variable, treatment block (BLT vs. sBLT) as predictor of 
interest, treatment sequence as a covariate, and subject intercept as a random effect. 
Bivariate and colinear relationships will be assessed and proxy variables may be created to 
adjust for variables that are strongly biased (>3 SD from the mean) or highly collinear with a 
model-pertinent variable. Covariates we will be assessing include demographics (age, sex, 
race), comorbid conditions, lifestyle behaviors (smoking, alcohol use, substance use), 
adherence to BLT treatment, adherence to CPAP, medications for treatment of depression, use 
of hypnotic medications, and healthcare utilization (number of inpatient/ER visits within the 
past year).
SA2: to test the effects of bright light therapy on sleep related functional impairment, quality 
of life and CPAP-resistant symptoms of sleepiness and depression during the four-week active 
treatment portion of the eight-week crossover study, compared to the four-week sham 
treatment portion. These exploratory analyses will include bivariate analyses comparing patient 
outcomes between treatment and sham time periods by utilizing repeated measures ANOVA for 
quality of life and the Friedman test for categorical variables. We will conduct multi-level mixed 
effects models of each outcome while adjusting for covariates as listed in the primary aim.
SA3: to test the effect of BLT on CPAP resistant daytime symptoms through reduced 
variability of circadian rhythms, assessed via actigraphy. In order to test this, we will first 
generate relevant rest-activity rhythms (RAR) measures from minute by minute actigraphy 
measurements collected over seven days: RAR height (amplitude, mesor), timing (up‐mesor , 
acrophase, down‐mesor).  RAR parameters will be modelled from minute‐to‐minute actigraphy 
count data using a five‐parameter extended sigmoidally transformed cosine model with an anti‐
logistic function. This model has been shown to fit human RAR data more effectively than a 
standard cosine curve49. The extended cosine model also provides a measure of how well the 
observed activity data are fitted by the 24‐h rhythm model known as the pseudo‐F statistic; 
lower values indicate poorer model fit and suggest an erratic or variable rhythm50. Bivariate 
analyses of the effect of BLT on variability of circadian rhythms parameters will be compared 
using repeated measures ANOVA. We will conduct multi-level mixed effects models of each 
outcome while adjusting for covariates as listed in the primary aim.
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ID: Pro00003376
View: 5 Sub-Studies
1.0 
* Is there a sub-study or are there sub-studies associated with this study?
There is no sub-study associated with this study. 
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ID: Pro00003376
View: 6 Study Population Summary
Study Population Summary
1.0
* What is the maximum number of subjects you plan to enroll at VAPHS?
25
2.0
* Do you plan on enrolling patients into different categories:
Yes
No
If yes, please explain:
This is a 2-arm cross-over study with each participant receiving both arms of treatment for 4 
weeks each separated by one week of wash-out period to minimize carry over effects. The order of 
treatment is randomly assigned.
3.0
If this is a multi-site study, indicate the projected total subject accrual:
N/A
4.0
* Please provide a justification for the sample size:
Sample size strictly based on statistical power is not applicable in the proposed pilot trial. This 
study is mainly aimed at testing feasibility of the proposed design and intervention, rather than 
hypothesis testing through inferential statistics. The statistics and qualitative data obtained from 
the proposed pilot trial will be used to inform design adjustments in the subsequent large trial. 
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ID: Pro00003376
View: 6.1 Study Population
Study Population
1.0
* Check all that apply to describe your study population:
Study Population
Non-Veterans

Special Populations

Veterans
Vulnerable populations
Other
2.0
* Indicate the inclusion criteria for enrollment:
1) Male or female veterans aged 45-65
2) Documented diagnosis of OSA, currently on CPAP or BiPAP with documented adherence 
(defined as wearing CPAP/BiPAP for >4h/ night on at least 75% of nights)
3) Excessive residual daytime sleepiness (Epworth score >/= 10)
4) Minimal sleep time, i.e. average total sleep time (TST)≥6 hours
3.0
* Indicate exclusion criteria for enrollment:
1) shift work
2) Travel across time zones in past month
3) Narcolepsy
4) Decompensated congestive heart failure (CHF)
5) Dementia, or bipolar disorder 
6) Macular degeneration
7) Recent (within 3 months) lasik surgery or planned lasik surgery in the next 3 months
8) Taking medication that will cause photosensitivity to blue-green light spectrum wavelength
9) Poorly controlled diabetes (HgA1c>8%)
10) Active substance use disorder
11) Currently taking alertness-promoting agents such as Modafinil or stimulants
12) Current enrollment in another Greater than minimal risk study
4.0
If there are any age, ethnic, language, or gender-based exclusion criteria, including the 
exclusion of any pregnant or lactating women, or those of child-bearing potential, 
please provide justification:
N/A
5.0
Please specify why vulnerable subjects and/or special populations will not be enrolled: 
6.0
With some exceptions as listed in VHA Handbook 1200.05, incompetent subjects cannot 
be enrolled in VAPHS approved research. Specify that you will not enroll incompetent 
subjects and the general rules to be used in making that determination:
Incompetent subjects will not be enrolled.
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ID: Pro00003376
View: 6.3 Study Population- Special Populations
Study Population
1.0
* Check all that apply to describe your study population:
Name
Employee and Student Subjects

Investigators Clinical Population
2.0
* Provide a justification for including these subjects:
Dr. Soreca is a sleep provider clinician so she will recruit from her patients when appropriate. 
Some may be her own patients, but the majority will be other provider’s patients. We have 
selected special populations in the event that any subject is from her own case load.
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ID: Pro00003376
View: 6.3.2 Investigators clinical population
Investigators clinical population
1.0
* Please indicate how you will minimize the potential for them to feel coerced to 
participate.  Discuss how the potential confusion in roles will be addressed:
The informed consent document emphasizes the investigator's conflict of interest and voluntary 
participation of the patient. Dr. Soreca will emphasize that fact to the patient when they are 
potentially eligible to participate in this study.
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ID: Pro00003376
View: 7 Risk/Benefit Assessment-Risks
Risk/Benefit Assessment-Risks
1.0
* Risk classification for this study (select one).
Name
Minimal Risk
Greater than Minimal Risk
2.0
* Basis for making the above recommendation:
The device used in this study, the Re-timer® glasses, is commercially available and in use by the 
general population, and is available without a prescription and individuals are not prevented from 
buying it, hence the level of risk incurred by the participant is not greater than what they may 
incur in daily life, as they could go online and buy it.
The light intensities used in this study are greater than most indoor light, but much dimmer than 
sunlight on a bright day.
The Re-timer® device is commercially available and not FDA-regulated because it is considered a 
minimal risk system, and is currently being used in a Michigan Medicine study in patients with 
postpartum depression.
3.0
* Describe the safety precautions that will be taken to minimize risks/harms:
Education about use of the study equipment. Instruction on proper home use for the BLT glasses 
will be provided by study staff.
Any issues will be addressed at each of the scheduled study visits.
In addition there will be a phone call to each subject 1 week after receiving the study glasses to 
address compliance and any issues they may be having.
During the assessments (both phone and in person), the participant will be directed to verbalize to 
the PI or research staff if they are having any discomfort and all research activity will be stopped if 
necessary.
Additionally, any issues will be addressed at each of the scheduled study visits.
If a participant responds to the questionnaires indicating that they are at risk for suicidality, 
the physician investigator will be consulted. Based on the information obtained, the PI or co-
investigators will evaluate suicide risk and decide what level of care is sufficient in conjunction 
with participants’ behavioral health clinician. If the participant does not have a behavioral health 
clinician, they will be referred to behavioral health for evaluation and treatment.
4.0
* Provide details regarding the nature of each risk using the area provided below:
Risk Name
View wearing bright light therapy glasses
View Privacy and confidentiality
View Wearing ActiWatch
5.0
* Do you plan on using the research answering service:
Yes 
No
If yes, please Upload the research answering service form:
6.0
If your study involves a treatment or intervention, please upload the Patient ID Card:
Patient ID card (0.01)
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ID: Pro00003376
View: 7.1 Risk/Benefit Analysis-Potential Benefits and Alternatives
Risk/Benefit Analysis-Potential Benefits and Alternatives
Describe any potential for direct benefits to participants in this study:
1.0
* Benefit to Subjects:
Hypothesis: The effect of BLT on CPAP resistant daytime symptoms will be exerted through 
increased regularity of circadian rhythms, assessed via actigraphy. At the completion of this 
project, we will have generated preliminary data critical to the design and implementation of a 
larger trial investigating the impact of BLT on CPAP-resistant symptoms of sleepiness and 
depression, leading to increased functional impairment in OSA patients. If proven effective, this 
intervention has the potential to improve the lives of many Veterans suffering from OSA who do 
not find full symptomatic relief with CPAP, by offering a non-pharmacological intervention that is 
safe, relatively inexpensive and whose implementation demands only a minimal degree of 
behavioral modification on the patient.
2.0
* Describe alternatives (research or non-research) that are available to subjects if they 
choose not to participate in this study:
not participate
other research opportunities
VAPHS Standard of Care (patient dependent)
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ID: Pro00003376
View: 8 Methods of Recruitment and Retention
Recruitment Methods and Materials used for Retention
1.0
* Select recruitment methods used on this study:
Name
Mail Campaign
Referral by independent source
Advertising such as fliers, letters, or ads (newspaper, TV, radio)
Web Site
Research registry

Selected from pre-existing records

Pre-existing relationship with participants
Other
If Other Methods Specify:
2.0
* Specify how subjects will be identified and how study eligibility will be determined:
We will request a waiver of HIPAA to review the CPRS records of veterans coming for a follow up 
appointment at the VAPHS Sleep Center. Those that are age 45-65 with a documented diagnosis 
of OSA and have a documented adherence to CPAP/BiPAP of at least 75% of nights and Epworth 
score > 10 according to their medical record, will be considered for screening. The clinician seeing 
(in person or by tele visit) the patient will be contacted by encrypted email asking if they agree to 
suggest to their patient that they may be eligible to participate in a research study. They can hand 
the patient (or mention) a brochure describing the study (IRB-approved). If (s)he is interested in 
participating, (s)he will have the option to undergo an in-person meeting or call the study 
research coordinator, whose contact information will be provided in the brochure, at another time 
so the research coordinator can answer any questions the subject may have about the study. 
There will be no cold calling of veterans who do not express interest in participating. Those who 
choose to meet in person will sign an informed consent. Those who would like to participate in the 
study will undergo remote consent over the phone.
Screening Procedures: Participant eligibility (see inclusion/exclusion criteria above) will be initially 
determined by the Inclusion and Exclusion Criteria document based on CPRS records. If there is 
criteria unable to be answered during the pre-screening process, this does not eliminate the 
potential participant. If eligible or potentially eligible based on the pre-screen, the participant will 
be invited to come in for on-site evaluation. After being consented, any unanswered questions 
from the Inclusion and Exclusion Criteria document will be asked. If confirmed to be eligible, the 
patient will continue. If not, the subject will be considered a screen fail and participation in the 
study will end. 
3.0
* Provide the location (or locations) of the sites where participants will be recruited:
VAPHS sleep clinic
4.0
Please include information regarding any advertisements (print, TV, radio, etc) that will 
be used to recruit subjects including a general description of where this information will 
be posted:
Approved brochure located in VAPHS Sleep Clinic
5.0
Please UPLOAD the documents that will be used for recruitment and an introductory 
statement or letter to accompany consent for those studies obtaining written informed 
consent using methods such as fax, email or mail (if applicable). Please also upload any 
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screening/recruitment questions that will be verbally asked of potential research 
subjects.  Also, if you will be providing any retention materials, please upload them 
here.
Name
Reviewer
Modified Date
Version 
Number
APPROVAL RE_ Review_ Bright Light Therapy study 
brochure.pdf
Roberts, 
Jodilyn
2/26/2020 1:33 
PM
0.01
Bright-Light-Therapy_Research-
study_brochure2.pdf
Roberts, 
Jodilyn
2/26/2020 1:33 
PM
0.01
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ID: Pro00003376
View: 9 Informed Consent
Informed Consent
1.0
* Indicate the types of consent that will be involved in this study (check any or all that 
apply):
Informed Consent Category
Written/signed consent by subject
Waivers are being requested.
2.0
* Waivers: If you are applying for any waivers of consent (check any or all that apply):
Name
Waiver of Informed Consent

Waiver of HIPAA Authorization

Waiver of Documentation of Informed Consent ( telephone consent, verbal script)
No Waiver at all
3.0
* Will this study include non-English speaking participants?
Yes 
No
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ID: Pro00003376
View: 9.1 Waiver of HIPAA
You have indicated you are requesting a waiver of HIPAA. 
1.0
* Is the request only for Screening/Recruitment purposes?
Yes 
No
If yes, please describe your screening/recruitment method:
If no, the request is for the full study (e.g. retrospective chart reviews and certain observational 
studies)
Please describe the types of records and/or databases to be accessed:
VAPHS Sleep Clinic scheduled patients' CPRS records to identify potential subjects.
The request reflects the need to potentially perform the entire study remotely with those 
participants that request to do so.
THE IDENTIFIABLE INFORMATION BEING REQUESTED:
Note: If participants will be receiving payment and HIPAA Authorization is not being obtained, you 
must select Names, Addresses and Social Security Numbers as that information will be disclosed for 
payment purposes.
2.0
* Identifiable Information per HIPAA Definition
Name
None
Account numbers
Biometric identifiers, including finger and voice prints
Certificate/license numbers
Device identifiers and serial numbers

Elements of dates (except year, for example, date of birth, admission date, 
discharge date, date of death, date of procedures; and all ages over 89)
Email Address
Fax Numbers
Full-face photographic images or any comparable images

Geographical subdivisions smaller than a State (street address, city, county, 
precinct, zip code, and their equivalent geocodes, except for the initial three digits 
of a zip code)
Health plan beneficiary numbers
Internet Protocol (IP) address numbers
Medical Record Numbers

Name or any derivative of name such as initials

Social Security Numbers

Telephone Numbers
URLs (Web Universal Resource Locators) 
Vehicle identifiers and serial numbers, including license plate numbers
Any other unique identifying number, characteristic, or code (Note: The study ID number, 
code or other means of record identification is not considered one of the identifiers that must 
be excluded for de-identification)
3.0
* Patient Protected Health Information:
Name
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Name

Demographic Information (e.g., Name, Address, Phone Number, Social Security 
Number
Billing and Payment Information

Hospital or Medical Records

History and Physical Exam Notes
Mental Health Records
Data Previously Collected for Research Purposes

Progress Notes

Consultation Reports
Laboratory Test Results
Operative Reports
Other
Please indicate the 'Other' Patient Protected Health Information:
4.0
Other Health Information:
Name
There are no items to display
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ID: Pro00003376
View: 9.1.1 Waiver of HIPAA - More Information
Waiver of HIPAA- More Information 
1.0
* Describe how the identifiable information is to be used and/or disclosed only by 
members of the research team and the following persons (identify with specificity and 
justify the need to disclose the information to anyone outside the VHA.) Note: If 
participants will be receiving payment and HIPAA Authorization is not being obtained, 
you must also describe this disclosure to representatives of the VA for administrative 
purposes here. 
Also describe how this activity meets the “minimum necessary standard” described in 
the HIPAA Privacy Rule:
The identifiable information (patient name and social security number) will be used by the study 
team members to access potential subjects electronic medical records for pre-screening to assess 
study eligibility and also to submit study payments. The information will not be disclosed to 
anyone outside the VHA.
By being able to pre-screen the charts in CPRS this will allow for the maximum patient enrollment 
with minimal amount of confusion and post-consent screen failures.
It is anticipated that not all patients in the Sleep Clinic will meet initial eligibility criteria and 
therefore it would require contact with a large number of patients who would likely subsequently 
screen negative, making the conduct of the study prohibitive. This would be a better use of time 
to pre-screen scheduled patients.
The proposed study poses minimal risk to the privacy of the subjects because...
2.0
* Describe how the identifiable information will be protected from improper use or 
disclosure by (detail how this will be accomplished including the limitations of physical 
or electronic access to the information and other protections):
The identifiable information will only be used by the study team member conducting the pre-
screening chart review and will not be disclosed to anyone outside of the study or outside of the 
VHA. CPRS review will be limited to review of the primary care history, and physical exam notes 
and progress notes, for the purpose of determining if the potential participant meets inclusion and 
exclusion criteria.
3.0
* Describe how the identifiers will be destroyed at the earliest opportunity consistent 
with the research (discuss the timeframe or the reasons the identifiers must be 
retained, including health or research justifications or any legal requirement to retain 
them) (Note: At this time, identifiers used for research screening and all other screening 
records must be retained indefinitely and this must be documented by checking “Other” 
below):
Screening is only to identify potential subjects. Once study accrual is completed, all research 
records will be maintained in accordance with the Veterans Health Administration (VHA) Records 
Control Schedule. Paper records will be disposed of using methods deemed appropriate by the 
VAPHS Privacy Officer, and all electronic data will be sanitized using methods rendered appropriate 
by the VAPHS ISO.
* When will screening data be de-identified or destroyed:
Name
Other
If Other, please describe:
All research records will be maintained in accordance with the Veterans Health Administration 
(VHA) Records Control Schedule. Paper records will be disposed of using methods deemed 
appropriate by the VAPHS Privacy Officer, and all electronic data will be sanitized using methods 
rendered appropriate by the VAPHS ISO.
4.0
* Describe how the identifiable information will not be reused or disclosed to any other 
person or entity outside the VHA other than the manner described in the protocol, 
except as a required by law, for authorized oversight of this research study, or as 
specifically approved for used in another study by an IRB:
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The identifiable information will not be reused or disclosed to any person or entity outside the 
VHA, except as required by law, for authorized oversight of this research study.
5.0
* Describe why the proposed study cannot be practicably conducted  without a waiver of 
authorization: (discuss reasons why it would not be possible to obtain authorization 
from individual subjects.  Time constraints themselves are generally not considered 
adequate for this justification:
By being able to pre-screen the charts in CPRS this will allow for the maximum patient enrollment 
with minimal amount of confusion and post-consent screen failures.
It is anticipated that not all patients in the Sleep Clinic will meet initial eligibility criteria and 
therefore it would require contact with a large number of patients who would likely subsequently 
screen negative, making the conduct of the study prohibitive.
6.0
* Describe why the proposed study cannot be done without the specified identifiable 
information: Discuss reasons why it would not be possible to conduct the research 
without the identifiable information being collected.
The specified identifiable information is necessary to adequately pre-screen potential participants 
for the study. The identifiable information is necessary to access the electronic medical record of 
the potential participant in order to review their medical history to determine study eligibility. 
Many patients in the Sleep Clinic will not meet initial eligibility criteria given the exclusion criteria. 
Without pre-screening, a large number of patients would have to be contacted and would likely 
subsequently screen negative, making the conduct of the study prohibitive.
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ID: Pro00003376
View: 9.3 Waiver of Documentation of Informed Consent
Waiver of Documentation of Informed Consent
You have selected a waiver of Documentation of Informed Consent
1.0
This is a request for Waiver of Documentation of Informed Consent because this 
research study conforms to either A and/or B (Check if ‘yes’ and provide the verifying 
information requested): 
* A: The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality.  Each subject will 
be asked whether the subject wants documentation linking the subject with the research, and the 
subject's wishes will govern.    
Yes
No
AND/OR
* B: The proposed study poses minimal risk to the subjects.   
Yes
No
If yes, please explain why the proposed study poses minimal risks to the subjects.  (Outline the 
subject’s involvement in the project and why the study poses minimal risk) :
The questionnaires done with the subject are for collection of data through this non-invasive 
process. Subjects do not have to answer any questions that make them uncomfortable.
The paper sleep diary serves the purpose of providing data which is used to proceed in 
determining current sleep patterns. This is needed to set the start time for wearing the Re-Timer 
glasses for 60 minutes daily.
The Actiwatch is worn like a wristwatch and can be removed if the subject experiences any 
irritation. These all have non-significant risk.
Since we are in a time where it is often safer for participants to communicate from home, this 
study is offering them the ability to do so. Because all of these procedures and devices do not 
have significant risk, we are asking for the Waiver of Documentation of Informed Consent.
2.0
*  The research involves no procedures for which written consent is normally required 
outside of the research context. Research procedures include:
Questionnaires, a sleep diary, wearing Re-Timer glasses and an actigraphy. These activities are all 
deemed minimal risk and thus do not require written consent.
3.0
* Explain how whenever appropriate, the subjects will be provided with additional 
pertinent information (e.g. an information sheet):
Subjects will be initially supplied with an information sheet detailing the timeline of the study as 
well as descriptions of each visit/study activity that they will be asked to do. They will also receive 
contact information for each study staff member and receive information sheets on each study 
device that they are provided.
4.0
Please upload SCRIPT here:
CLEAN- Bright DayS Consent Script_10_8_2020(0.05)
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ID: Pro00003376
View: 9.4 Consent Forms & Process of Consent
Consent Forms & Process of Consent
1.0
Upload the completed forms into the correct lists below.
1.1
Informed Consent Form (clean copy):
Document
Modified Date
Version Number
View CLEAN-SPIRE Consent 10.8.2020.doc(0.02)
10/8/2020 12:00 AM
0.02
1.2
Provider Behavior Informed Consent Form (clean copy):
Document
Modified Date
Version Number
There are no items to display
1.3
Screening Informed Consent Form (clean copy):
Document
Modified Date
Version Number
There are no items to display
2.0
Consent Forms (modified copy):
Document
Modified Date
Version Number
View TRACKED-SPIRE Consent 10.8.2020.doc(0.02)
10/8/2020 12:51 PM
0.02
3.0
* Describe how, where, when, and by whom the consent process will be initiated:
The Sleep Clinic schedule will be reviewed by both the PI and study coordinator to identify 
potential patients. Subjects will be identified by the study staff or may be referred by clinical staff 
in the Sleep Clinic. The PI will also recruit patients from her clinic. The PI will discuss the study 
with the clinical providers and staff and ask them to let her know of any patients who may qualify. 
Those patient’s charts will then be pre-screened in CPRS to see if they may be eligible. If the 
coordinator finds a patient that may be eligible, the coordinator will contact a member of the 
patient’s clinical care team. The patient will be approached by a member of the research team who 
is also part of the clinical care team to see if they are interested in participating in research 
opportunities. If the patient expresses interest, the consent will be provided to the patient. If 
there is no member of the research team who is also part of the clinical team, the clinical team will 
inform the patient about the study and pass along the patient’s information to the research team if 
the patient expresses interest in the study and agrees to have their information forwarded to the 
research team for contact. If the clinical coordinator is available, she will come to speak with the 
patient. If the patient is ambulatory this will be done in an empty conference room or empty exam 
room. If the patient is not ambulatory, the curtain will be drawn, and the discussion will be kept 
quiet to ensure patient confidentiality. The patient may take time to review this with family. Once 
the patient has reviewed the consent and had all questions answered the consent process will be 
completed in the Sleep clinic by the Principal Investigator.
4.0
* Will you be maintaining a Master List of Subjects?
Yes 
5.0
* Describe when the subject’s name will be added to the master list and how the list will 
be maintained in a secure fashion.  
Once the patient is enrolled in the study, they will be added to the master list of subjects. This will 
be maintained in CPRS on a personal list and on a VAPHS shared drive; \\vhapthmul6
\Pro3286_Soreca, that only study team will have access to.
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ID: Pro00003376
View: 10.0.0 Data Security and Privacy: Data Types Storing
10.0 Data Types Collecting and Storing
1.0
Click the add button (below) to open an entry form to indicate the types and/or sources 
of the data that will be collected/stored as part of the project. 
Instructions: For each type/source of data that will be collected as part of the project, 
this includes screening data, click the add button to open an entry form that lists the 
types and/or sources of data. Select a source/type of the data that will be 
collected/stored. Then indicate what, if any, identifiers or sensitive information will be 
collected/stored from the source/type (None is an option). To add another source/type 
click “OK Add Another” button to open up a new entry form to repeat the process.
Example 1: You are collecting data from VA Medical records including names, last 4 of 
SSN, and addresses. Therefore, you would select “VA medical record data” as the 
source, and then select in the identifiers: “Name or any derivative of name, such as 
initials,” “Social Security Numbers,” and “Geographical subdivisions smaller than a 
State (street address, city, county, precinct, zip code, and their equivalent geocodes, 
except for the initial three digits of a zip code)” as the identifiers being collected.
Example 2:  You are screening VA Medical Records and recording the information you 
use to screen (i.e.: names, last 4 of SSN, and addresses, etc.)  Note: This information 
must be treated as a Source document, please select “Screening” as the source and then 
select the identifiers “Name or any derivative of name, such as initials,” “Social Security 
Numbers,”, as applicable.
* 
Data Type/Source
Collection Details
Identifiers
View Questionnaires/Surveys, 
paper
Any data will be collected by 
approved member of the 
research study team. It will 
be recorded on paper. 
Questionnaires response will 
be recorded on paper and 
then transferred to VA 
REDCap electronic data 
capture for analysis. Paper 
is stored in the locked 
Research Office Building in a 
locked cabinet accessible 
only by the study staff. 
Electronic data is saved on 
the study shared drive, 
again only accessible by the 
study staff.
Elements of dates 
(except year, for 
example, date of 
birth, admission 
date, discharge 
date, date of 
death, date of 
procedures; and 
all ages over 89)
Telephone 
Numbers
Social Security 
Numbers
Geographical 
subdivisions 
smaller than a 
State (street 
address, city, 
county, precinct, 
zip code, and 
their equivalent 
geocodes, except 
for the initial 
three digits of a 
zip code)
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Data Type/Source
Collection Details
Identifiers
Name or any 
derivative of 
name such as 
initials
Device identifiers 
and serial 
numbers
View Other
Actigraph
The Actigraph system 
comes with an Actigraphy 
(watch), charger and 
software. There is a USB in 
the device that is removed 
and the data then 
transferred to a computer 
with the software. The data 
is scored and saved to the 
study drive and recorded in 
the study specific RedCAP 
database. The data is then 
erased from the computer.
Device identifiers 
and serial 
numbers
View VA medical record data 
(i.e., diagnoses, 
procedures, visits) via 
chart review
Using the waiver of HIPAA, 
study staff will pre-screen 
VAPHS Sleep clinic 
scheduled patients for 
potential participants based 
on general inclusion and 
exclusion criteria. This 
information will be stored 
on paper charts by subject 
and kept in a locked cabinet 
in a locked building (ROB).
Elements of dates 
(except year, for 
example, date of 
birth, admission 
date, discharge 
date, date of 
death, date of 
procedures; and 
all ages over 89)
Social Security 
Numbers
Name or any 
derivative of 
name such as 
initials
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ID: Pro00003376
View: 10.0.1 Data Security and Privacy: Social Security Numbers
10.0.1 Data Security and Privacy: Social Security Numbers
1.0
You indicated that you will be using all or some part of the research subjects' SSNs as 
part of this study.  Which of the following will you be using:
Real Social Security numbers 
* 
Yes
No
Scrambled Social Security numbers
* 
Yes 
No
Last 4 digits of Social Security Number * 
Yes
No
Other (some derivation of the SSN)
* 
Yes 
No
If other, please explain:
2.0
* Please describe how subjects’ Social Security numbers will be used in this study:
Full social security number is required to submit reimbursement request.
Last 4 of the social security number is used to access the subject's medical record.
3.0
* Please describe the security measures that will be taken to protect SSNs.
SSNs will be used for participant payments and will be on the 10-7078 form and will be kept in a 
binder in a locked cabinet in the study coordinator's office in the Research Office Building.
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ID: Pro00003376
View: 10.1.0 Data Security and Privacy: Incoming Data
10.1.0 Incoming Data 
1.0
* Will data be transferred into VAPHS?
No. Data is not being transferred into this facility
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ID: Pro00003376
View: 10.2.0 Data Security and Privacy: Outgoing Data
10.2.0 Outgoing Data 
1.0
* Will any of the data being collected/stored be transferred outside of VAPHS?
No. The data is not being transferred outside of this facility.
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ID: Pro00003376
View: 10.3.0 Data Security and Privacy: Local Data Storage Types
10.3.0 Local Data Storage Types 
1.0
* How will data be stored on this project? (Select all that apply)
On Paper
Electronically
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ID: Pro00003376
View: 10.3.1 Data Security and Privacy: Local Data Storage Types - Paper
10.3.1 Local Data Storage Types - Paper 
1.0
* All VA research data collected in paper must be stored in a locked room at VAPHS. 
List the room number(s) and the campus(es) where data will be stored in the text box 
below.
Study staff will maintain the data in the Research Office Building (which is locked) in a locked 
cabinet at the study coordinators cube, 1-27.
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ID: Pro00003376
View: 10.3.2 Data Security and Privacy: Local Data Storage Types - Electronic
10.3.2 Local Data Storage Types - Electronic
1.0
* Where is the electronic data being stored? Select all that apply.
VAPHS Network (shared drive)
Other
If "Other" please describe OR if you would like to provide additional information for 
clarification, please elaborate in the text box below.
VA RedCap
If you selected VAPHS or VA Network (Shared Drive), please provide the name of the 
drive (i.e. "MySharedDriveName (\\vapthshsare) (X:)"):
(Z:)Pro3286_Soreca(\\vhapthmul6)
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ID: Pro00003376
View: 10.4.0 Data Security and Privacy: Reusing Data
10.4.0 Data Security and Privacy: Reusing Data
1.0
* Will the data collected in this study be reused in other studies?
Yes
No
If yes, please describe where the data to be reused will be stored and how access to 
that data will be provided and monitored:
Access to the data will be limited to the individuals named in the informed consent document and 
HIPAA Authorization signed by the study subjects.
The data will be used in future studies as this is a pilot and feasibility study.
2.0
If this research is part of a grant, please upload the Data Management Access Plan 
(DMAP) or Resource Sharing Plan for this study.
Name
Modified Date
There are no items to display
The DMAP is uploaded with the grant in Section 1.3".
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ID: Pro00003376
View: 10.6.0 Data Security and Privacy: HIPAA
10.6.0 Data Security and Privacy: HIPAA
The Healthcare Insurance Portability and Accountability Act(HIPAA) prohibits the use of a person's 
Protected Health Information without a valid authorization.
1.0
* Select the option which fits this study:
Name
Not applicable: No PHI is being used or disclosed by VAPHS
Not applicable: Waiver has been requested
HIPAA Authorization
Upload HIPAA authorization (clean copy) here:
Document
Modified Date
Version Number
View HIPPA Combined With Consent Clean.docx(0.01)
1/10/2020 9:18 AM
0.01
Upload HIPAA authorization (tracked changes) here:
Document
Modified Date
Version Number
View HIPPA Combined With Consent Tracked.docx(0.01)
1/10/2020 9:18 AM
0.01
2.0
At screening will clinical personnel be asked to share potential participants PHI:
Yes 
No
 If yes, please upload the 10-5345:
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ID: Pro00003376
View: 10.7.0 Data Security and Privacy: Additional Information
10.7.0 Data Security and Privacy: Additional Information
1.0
Does this research involve...
* ...specially obtained software?
Yes
No
If yes, please describe the software and what it is being used for:
Data will be analyzed with Actiware 6.0.9 software (Philips Respironics), using the medium 
sensitivity setting. A validated algorithm for sleep scoring each 30 second epoch will be used. 
These data will be used to characterize habitual sleep and establish a stable index of mid-sleep 
time (MST), which is needed for calculation of circadian outcomes.
The VA Sleep Clinic has a license for the Actiware 6.0.9 software (Philips Respironics). This 
software is VA TRM approved and all constraints will be followed.
* ...one or more Web-based applications?
Yes
No
If yes, please describe the application and what it is being used for:
VA RedCAP is the web-based application used to record participant data. The data stored will be 
from surveys, demographics, screening and eligibility data. Information will be de-identified other 
than dates of specific assessments.
* ...mobile devices?
Yes
No
If yes, please describe:
The Phillips Respironics Actiwatch 2 will be used. The participants will start to wear it following 
consent and continue to wear it for the entire 9 weeks of the study.
The device does not have wireless capability.  No data will be transmitted to the cloud.  The 
devices come with a charger and software. It has a small USB which is used to transfer the data to 
a computer.  The data is then scored and transferred to the study data base and entered into 
RedCAP.  The data is then erased from the original computer. 
2.0
* Will a Certificate of Confidentiality be obtained for this study?
Yes 
No
If yes, please attach the Certificate of Confidentiality:
3.0
* Will VA sensitive information be transported and utilized outside protected 
environments?
Yes 
No
If you answered yes above, please upload a fully executed VAPHS Memo to Take VA Sensitive 
Information Outside a Protected Environment by following these instructions .
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ID: Pro00003376
View: 10.8.0 Data Security and Privacy: Certifications
10.8.0 Certifications
1.0
* I certify that all study staff are up-to-date and will remain up-to-date with 
Information Security Awareness Training, Rules of Behavior, and VHA Privacy Training.
Yes
No
2.0
* I also certify that when an individual is no longer part of the study team, access will 
be removed to research study data.
Yes
No
3.0
* I certify that all research records will be maintained in accordance with the Veterans 
Health Administration (VHA)Records Control Schedule. Paper records will be disposed of 
using methods deemed appropriate by the VAPHS Privacy Officer, and all electronic data 
will be sanitized using methods rendered appropriate by the VAPHS ISO. 
Yes
No
4.0
* I certify that any loss or compromise of any VA sensitive information (including 
research data), VA equipment or device, or any non-VA equipment or device that is used 
to transport, access, or store VA information will be reported in accordance with the 
reporting requirements outlined in VA Handbook 6500.
Yes
No
5.0
* I certify that, in accordance with VA Handbook 6500, no personal laptops will be used  
for official VA business in conjunction with this study.
Yes
No
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ID: Pro00003376
View: 11 Local Data Safety Monitoring Plan
Local Data Safety Monitoring Plan
 For local studies, a data and safety monitoring plan (DSMP) must be established.
1.0
* Please describe how the study procedures and data being collected will be 
continuously monitored so that changes in the risk/benefit ratio can be determined in a 
timely fashion during the course of the study:
The data monitoring plan will ensure that there is no change to the risk/benefit ratio during the 
course of the study and that confidentiality of research data is protected.  The principal 
investigator, Dr. Soreca, and study personnel will meet at 1 month intervals and additional check-
ins as needed to re-evaluate study goals, subject recruitment and retention, data coding and 
analysis, documentation and identification of adverse events, complaints, protocol deviations, and 
violations of confidentiality.  Modifications to the protocol and to the consent document will be 
recommended as determined by the Data Monitoring Plan. Adverse events will be reported to the 
IRB.  Study renewals will include a summary report and interpretation of the findings of the Data 
Monitoring Plan for the previous years.
2.0
* Describe how frequently Investigators, study personnel, and the clinical coordinators 
involved in the study will meet and/or review study data.
Investigators, study personnel, and the clinical coordinators involved in the study will meet 
monthly to discuss the study goals, progress, modifications, documentation, recruitment, 
retention, data analysis and confidentiality and address any concerns or issues at the time.  These 
meetings will be overseen by Dr. Soreca.  Any instances of adverse events, protocol deviations, or 
other problems identified during the meetings will be reported as soon as possible within the 
required reporting timeframes using the standard forms and/or procedures set forth by the IRB.  
In addition, clinical coordinators may review study documentation and/or consent forms to ensure 
that subject's confidentiality is maintained.  
3.0
* Will this study use a Data Safety Monitoring Board or Data Monitoring committee? 
Yes 
No
4.0
* Will this study use a Medical Monitor?  
Yes 
No
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ID: Pro00003376
View: 12 Costs and Payments
Costs and Payments
1.0
* Does this study have a budget?:
Yes
No
If yes, please upload the current budget:
SPIRE budget(0.01)
2.0
* Will patients receive payments for this study?
Yes
No
If yes, please upload the financial letter of support (either from the Business Service line or the 
Veterans Research Foundation of Pittsburgh) or documentation waiving the requirement of a letter 
of support:
ALL SIGNED LOS memo - VA Financial _v3_Sept2018.soreca.jra.pdf
0.01
3.0
* Are you paying patients using the WePay system?
no 
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ID: Pro00003376
View: 12.1 Costs
Costs 
1.0
* Will subjects be required to pay for any services outside of the VHA that may be 
required as part of participating in this research study?
no
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ID: Pro00003376
View: 12.2 Participant Payments
Participant Payments 
1.0
* Please explain how the proposed payments are reasonable and commensurate with 
the expected contributions of the subject:
Subjects are only being paid $25 per visit (Baseline(Visit 2), Visits 3, 5 & 6) to compensate them 
for their time and travel.
2.0
* Please provide information on how the subject payments are fair and appropriate, and 
that they do not constitute (or appear to constitute) undue pressure or influence on the 
prospective research subjects to volunteer for, or to continue to participate in, the 
research study. In additional the payments do not constitute (or appear to constitute) 
coercion to participate in, or continue to participate in, the research study:
The payments for this study are only $25 a visit in order to help cover the costs of transportation 
and their time for participating in this study. The payment does not reflect undue pressure or 
influence on these patients.
3.0
* Specify the amount, form of payment and the specific disbursement schedule of 
payments:
Participants will be paid $25 for their participation in each assessment (Baseline(Visit 2), Visits 3, 
5 & 6) that they complete to pay for their time and travel. Payment will go by direct deposit into 
their checking account through EFT or onto a Direct Express card issued by Comerica. 
4.0
* Are the subjects being paid employees?
no 
If yes, please describe how it will be in accordance with the SOP:
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ID: Pro00003376
View: 14 References
References:
1.0
* Please provide a list of references (Multi-site protocols: You may reference the page 
numbers in the original protocol):
Bibliographic References
1 Alexander M, Ray MA, Hébert JR, et al: The National Veteran Sleep Disorder Study: Descriptive 
Epidemiology and Secular Trends, 2000-2010. Sleep 2016; 39(7): 1399–410. Doi: 
10.5665/sleep.5972.
2 Baniak LM, Chasens ER, Luyster FS, Strollo PJ, Thunström E, Peker Y: Obstructive sleep apnea 
and self-reported functional impairment in revascularized patients with coronary artery disease in 
the RICCADSA trial. Sleep Breath Schlaf Atm 2018; 22(4): 1169–77. Doi: 10.1007/s11325-018-
1733-4.
3 Vijayan VK: Morbidities associated with obstructive sleep apnea. Expert Rev Respir Med 2012; 6
(5): 557–66. Doi: 10.1586/ers.12.44.
4 Pépin J-L, Viot-Blanc V, Escourrou P, et al: Prevalence of residual excessive sleepiness in CPAP-
treated sleep apnoea patients: the French multicentre study. Eur Respir J 2009; 33(5): 1062–7. 
Doi: 10.1183/09031936.00016808.
5 Giles TL, Lasserson TJ, Smith BJ, White J, Wright J, Cates CJ: Continuous positive airways 
pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev 2006; (1): 
CD001106. Doi: 10.1002/14651858.CD001106.pub2.
6 Gagnadoux F, Le Vaillant M, Goupil F, et al: Depressive symptoms before and after long-term 
CPAP therapy in patients with sleep apnea. Chest 2014; 145(5): 1025–31. Doi: 10.1378/chest.13-
2373.
7 Mulgrew AT, Ryan CF, Fleetham JA, et al: The impact of obstructive sleep apnea and daytime 
sleepiness on work limitation. Sleep Med 2007; 9(1): 42–53. Doi: 10.1016/j.sleep.2007.01.009.
8 Pagel JF: The burden of obstructive sleep apnea and associated excessive sleepiness. J Fam 
Pract 2008; 57(8 Suppl): S3-8.
9 Tranah GJ, Blackwell T, Stone KL, et al: Circadian activity rhythms and risk of incident dementia 
and mild cognitive impairment in older women. Ann Neurol 2011; 70(5): 722–32. Doi: 
10.1002/ana.22468.
10 Guo VY, Cao B, Wong CKH, Yu EYT: The association between daytime napping and risk of 
diabetes: a systematic review and meta-analysis of observational studies. Sleep Med 2017; 37: 
105–12. Doi: 10.1016/j.sleep.2017.01.018.
11 Groeger JA, Lo JCY, Burns CG, Dijk D-J: Effects of sleep inertia after daytime naps vary with 
executive load and time of day. Behav Neurosci 2011; 125(2): 252–60. Doi: 10.1037/a0022692.
12 Moreira S, Rodrigues R, Barros AB, et al: Changes in Expression of the CLOCK Gene in 
Obstructive Sleep Apnea Syndrome Patients Are Not Reverted by Continuous Positive Airway 
Pressure Treatment. Front Med 2017; 4: 187. Doi: 10.3389/fmed.2017.00187.
13 Burioka N, Koyanagi S, Endo M, et al: Clock gene dysfunction in patients with obstructive sleep 
apnoea syndrome. Eur Respir J 2008; 32(1): 105–12. Doi: 10.1183/09031936.00138207.
14 Hernández C, Abreu J, Abreu P, Castro A, Jiménez A: Nocturnal melatonin plasma levels in 
patients with OSAS: the effect of CPAP. Eur Respir J 2007; 30(3): 496–500. Doi: 
10.1183/09031936.00051906.
15 van Maanen A, Meijer AM, van der Heijden KB, Oort FJ: The effects of light therapy on sleep 
problems: A systematic review and meta-analysis. Sleep Med Rev 2016; 29: 52–62. Doi: 
10.1016/j.smrv.2015.08.009.
16 Mårtensson B, Pettersson A, Berglund L, Ekselius L: Bright white light therapy in depression: A 
critical review of the evidence. J Affect Disord 2015; 182: 1–7. Doi: 10.1016/j.jad.2015.04.013.
17 Ancoli-Israel S, Rissling M, Neikrug A, et al: Light Treatment Prevents Fatigue in Women 
Undergoing Chemotherapy for Breast Cancer. Support Care Cancer 2012; 20(6): 1211–9. Doi: 
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10.1007/s00520-011-1203-z.
18 Rod NH, Kjeldgård L, Åkerstedt T, et al: Sleep Apnea, Disability Pensions, and Cause-Specific 
Mortality: A Swedish Nationwide Register Linkage Study. Am J Epidemiol 2017; 186(6): 709–18. 
Doi: 10.1093/aje/kwx138.
19 Zhao Y, Yu BY-M, Liu Y, Liu Y: Meta-Analysis of the Effect of Obstructive Sleep Apnea on 
Cardiovascular Events After Percutaneous Coronary Intervention. Am J Cardiol 2017; 120(6): 
1026–30. Doi: 10.1016/j.amjcard.2017.06.035.
20 Ruel G, Martin SA, Lévesque J-F, et al: Association between multimorbidity and undiagnosed 
obstructive sleep apnea severity and their impact on quality of life in men over 40 years old. Glob 
Health Epidemiol Genomics 2018; 3: e10. Doi: 10.1017/gheg.2018.9.
21 Vinnikov D, Blanc PD, Alilin A, Zutler M, Holty J-EC: Fatigue and sleepiness determine 
respiratory quality of life among veterans evaluated for sleep apnea. Health Qual Life Outcomes 
2017; 15(1): 48. Doi: 10.1186/s12955-017-0624-x.
22 Roure N, Gomez S, Mediano O, et al: Daytime sleepiness and polysomnography in obstructive 
sleep apnea patients. Sleep Med 2008; 9(7): 727–31. Doi: 10.1016/j.sleep.2008.02.006.
23 Vgontzas AN, Tan TL, Bixler EO, Martin LF, Shubert D, Kales A: Sleep apnea and sleep 
disruption in obese patients. Arch Intern Med 1994; 154(15): 1705–11.
24 Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S: The occurrence of sleep-disordered 
breathing among middle-aged adults. N Engl J Med 1993; 328(17): 1230–5. Doi: 
10.1056/NEJM199304293281704.
25 Bixler EO, Vgontzas AN, Ten Have T, Tyson K, Kales A: Effects of age on sleep apnea in men: I. 
Prevalence and severity. Am J Respir Crit Care Med 1998; 157(1): 144–8. Doi: 
10.1164/ajrccm.157.1.9706079.
26 Bixler EO, Vgontzas AN, Lin HM, et al: Prevalence of sleep-disordered breathing in women: 
effects of gender. Am J Respir Crit Care Med 2001; 163(3 Pt 1): 608–13. Doi: 
10.1164/ajrccm.163.3.9911064.
27 Marshall NS, Barnes M, Travier N, et al: Continuous positive airway pressure reduces daytime 
sleepiness in mild to moderate obstructive sleep apnoea: a meta-analysis. Thorax 2006; 61(5): 
430–4. Doi: 10.1136/thx.2005.050583.
28 Patel SR, White DP, Malhotra A, Stanchina ML, Ayas NT: Continuous positive airway pressure 
therapy for treating sleepiness in a diverse population with obstructive sleep apnea: results of a 
meta-analysis. Arch Intern Med 2003; 163(5): 565–71.
29 LaGrotte C, Fernandez-Mendoza J, Calhoun SL, Liao D, Bixler EO, Vgontzas AN: The relative 
association of obstructive sleep apnea, obesity and excessive daytime sleepiness with incident 
depression: a longitudinal, population-based study. Int J Obes 2005 2016; 40(9): 1397–404. Doi: 
10.1038/ijo.2016.87.
30 Björnsdóttir E, Benediktsdóttir B, Pack AI, et al: The Prevalence of Depression among 
Untreated Obstructive Sleep Apnea Patients Using a Standardized Psychiatric Interview. J Clin 
Sleep Med JCSM Off Publ Am Acad Sleep Med 2016; 12(1): 105–12. Doi: 10.5664/jcsm.5406.
31 Meijer JH, Colwell CS, Rohling JHT, Houben T, Michel S: Dynamic neuronal network 
organization of the circadian clock and possible deterioration in disease. Prog Brain Res 2012; 
199: 143–62. Doi: 10.1016/B978-0-444-59427-3.00009-5.
32 Abbott SM, Zee PC: Circadian Rhythms: Implications for Health and Disease. Neurol Clin 2019; 
37(3): 601–13. Doi: 10.1016/j.ncl.2019.04.004.
33 Duffy JF, Czeisler CA: Effect of Light on Human Circadian Physiology. Sleep Med Clin 2009; 4
(2): 165–77. Doi: 10.1016/j.jsmc.2009.01.004.
34 Phipps-Nelson J, Redman JR, Dijk D-J, Rajaratnam SMW: Daytime exposure to bright light, as 
compared to dim light, decreases sleepiness and improves psychomotor vigilance performance. 
Sleep 2003; 26(6): 695–700.
35 Viola AU, James LM, Schlangen LJM, Dijk D-J: Blue-enriched white light in the workplace 
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improves self-reported alertness, performance and sleep quality. Scand J Work Environ Health 
2008; 34(4): 297–306.
36 Lockley SW, Evans EE, Scheer FAJL, Brainard GC, Czeisler CA, Aeschbach D: Short-wavelength 
sensitivity for the direct effects of light on alertness, vigilance, and the waking 
electroencephalogram in humans. Sleep 2006; 29(2): 161–8.
37 Beaven CM, Ekström J: A comparison of blue light and caffeine effects on cognitive function 
and alertness in humans. PloS One 2013; 8(10): e76707. Doi: 10.1371/journal.pone.0076707.
38 Smolders KCHJ, de Kort Y a W, Cluitmans PJM: A higher illuminance induces alertness even 
during office hours: findings on subjective measures, task performance and heart rate measures. 
Physiol Behav 2012; 107(1): 7–16. Doi: 10.1016/j.physbeh.2012.04.028.
39 Wulff K, Gatti S, Wettstein JG, Foster RG: Sleep and circadian rhythm disruption in psychiatric 
and neurodegenerative disease. Nat Rev Neurosci 2010; 11(8): 589–99. Doi: 10.1038/nrn2868.
40 Caldwell JA, Knapik JJ, Lieberman HR: Trends and factors associated with insomnia and sleep 
apnea in all United States military service members from 2005 to 2014. J Sleep Res 2017; 26(5): 
665–70. Doi: 10.1111/jsr.12543.
41 Omachi TA, Claman DM, Blanc PD, Eisner MD: Obstructive Sleep Apnea: A Risk Factor for Work 
Disability. Sleep 2009; 32(6): 791–8.
42 Stepnowsky C, Sarmiento KF, Bujanover S, Villa KF, Li VW, Flores NM: Comorbidities, Health-
Related Quality of Life, and Work Productivity Among People With Obstructive Sleep Apnea With 
Excessive Sleepiness: Findings From the 2016 US National Health and Wellness Survey. J Clin 
Sleep Med JCSM Off Publ Am Acad Sleep Med 2019.
43 Fischer D, Lombardi DA, Marucci-Wellman H, Roenneberg T: Chronotypes in the US - Influence 
of age and sex. PloS One 2017; 12(6): e0178782. Doi: 10.1371/journal.pone.0178782.
44 Zhu L, Zee PC: Circadian Rhythm Sleep Disorders. Neurol Clin 2012; 30(4): 1167–91. Doi: 
10.1016/j.ncl.2012.08.011.
45 Burgess HJ, Rizvydeen M, Kimura M, et al: An Open Trial of Morning Bright Light Treatment 
Among US Military Veterans with Chronic Low Back Pain: A Pilot Study. Pain Med Malden Mass 
2018. Doi: 10.1093/pm/pny174.
46 Weaver TE, Laizner AM, Evans LK, et al: An instrument to measure functional status outcomes 
for disorders of excessive sleepiness. Sleep 1997; 20(10): 835–43.
47 Burgess HJ, Savic N, Sletten T, Roach G, Gilbert SS, Dawson D: The relationship between the 
dim light melatonin onset and sleep on a regular schedule in young healthy adults. Behav Sleep 
Med 2003; 1(2): 102–14. Doi: 10.1207/S15402010BSM0102_3.
48 Kantermann T, Burgess HJ: Average mid-sleep time as a proxy for circadian phase. PsyCh J 
2017; 6(4): 290–1. Doi: 10.1002/pchj.182.
49 Marler MR, Gehrman P, Martin JL, Ancoli-Israel S: The sigmoidally transformed cosine curve: a 
mathematical model for circadian rhythms with symmetric non-sinusoidal shapes. Stat Med 2006; 
25(22): 3893–904. Doi: 10.1002/sim.2466.
50 Smagula SF, Boudreau RM, Stone K, et al: Latent activity rhythm disturbance sub-groups and 
longitudinal change in depression symptoms among older men. Chronobiol Int 2015; 32(10): 
1427–37. Doi: 10.3109/07420528.2015.1102925.
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ID: Pro00003376
View: 15 Miscellaneous Documents
Miscellaneous Documents
If you have any documents that need to be included in this submission, but do not fit in any of the 
previous sections please upload them here.
Document
Description Version 
Number
View BrightDayS Info Sheet v1.2_072720-CLEAN.irb (1).doc(0.01)
0.01
View Pro 3376 DSMB comment 5_4_2020.pdf(0.01)
0.01
View Pro 3376_Investigator COVID Risk Assessment v8.7.6.2020. IS 
SIGNED_Soreca_FC.pdf(0.01)
0.01
View TRACKED- Bright DayS Remote Consent Script 10.8.2020.docx
(0.01)
0.01
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ID: Pro00003376
View: SF - Final Page
Final Page
You have completed your application!
Please hit "Finish" to save and exit the application.  Doing so will NOT submit the application for 
review.
Please note that a submission may only be forwarded to the IRB by the Principal Investigator.  To 
do this, the Principal Investigator must press the "SUBMIT STUDY" button in My Activities for this 
Study ID:Pro00003376.
You can track the ongoing status of your submission by logging into the study workspace.
Please feel free to contact the IRB with any questions or concerns.
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ID: Pro00003376
View: Create/Edit
Study Funding Source
1.0
* Funding Source Name:
Rehabilitation R&D (Prog 822)
If you can't find the Funding Source above, choose "Other" and enter it here:
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ID: Pro00003376
View: VA Create-Edit
* Device Name:
ActiWatch
* Use of Device:
FDA Approved Device used in approved manner
Manufacturer:
Respironics
IDE Class:
IDE Number(if Applicable):
Risk Level Determined by Sponsor: Non-Significant Risk
Upload Device Brochure
ActiWatch brochure(0.01)
Provide any other notes about how this device will be used or justification for lack of IDE number
The VA Sleep Clinic has a license for use of this device. The participant will be asked to wear a wrist actigraph. 
This is a small device that they wear on their wrist like a watch. The actigraph measures body movement, and 
helps us to see patterns of sleep, wakefulness, and activity. It is to be worn during the entire 9 weeks of the 
study. It can be worn while they sleep as well as when showering.
Is the investigator hold the IDE for this device?
Yes 
No
If yes please provide a basis for risk level. 
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ID: Pro00003376
View: VA Create-Edit
* Device Name:
Re-timer bright light therapy glasses
* Use of Device:
Investigational Device Not Yet Approved for use
Manufacturer:
Re-timer
IDE Class:
IDE Number(if Applicable):
Risk Level Determined by Sponsor: Non-Significant Risk
Upload Device Brochure
ReTimer glasses brochure(0.01)
Provide any other notes about how this device will be used or justification for lack of IDE number
The FDA has guidelines regarding the use of non-prescription sunglasses available for review. Bearing in mind 
that the device being used in this study are not sunglasses, we will refer to these guidelines in answering the 
comment as to why an IDE is not necessary. 
These glasses are commercially available and in use by the general population. They can be purchased online. 
This agrees with the guidelines stating that it is “…marketed directly to the end user (i.e., consumer) without 
the need for a prescription or any other order issued by a licensed eyecare practitioner….”
Also that they are”… Nonprescription devices are commonly sold or distributed as "over-the-counter" (OTC) 
devices.”
Finally, they meet international UV and blue light safety standards, they are brighter than most indoor lighting 
but dimmer than outdoor light on a bright day."
Is the investigator hold the IDE for this device?
Yes 
No
If yes please provide a basis for risk level. 
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ID: Pro00003376
View: Risk Detail Entry
Address for each screening procedure, research intervention/interatction, and follow-up/monitoring procedure: 
* Research Activity:
wearing bright light therapy glasses
Common Risks: 
Infrequent Risks:
headache, eyestrain
Other Risks:
discomfort
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ID: Pro00003376
View: Risk Detail Entry
Address for each screening procedure, research intervention/interatction, and follow-up/monitoring procedure: 
* Research Activity:
Privacy and confidentiality
Common Risks: 
Infrequent Risks:
Other Risks:
As a part of this study, private information is being collected; for that reason there is a risk to the subject's 
privacy and confidentiality. The research staff will take every precaution to protect the subject's identity 
and the confidentiality of the information collected.
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ID: Pro00003376
View: Risk Detail Entry
Address for each screening procedure, research intervention/interatction, and follow-up/monitoring procedure: 
* Research Activity:
Wearing ActiWatch
Common Risks: 
Infrequent Risks:
skin irritation
Other Risks:
discomfort
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