A Single Arm, Open-Label, Multi-Center, and Comparative Study of the Anne Sleep System Versus Polysomnography to Diagnose Obstructive Sleep Apnea: ANNE Program for the Non-Invasive Evaluation of Apnea in Sleep (APNEAs)
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Sponsor: Northwestern University

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Title: A Single Arm, Open-Label, Multi-Center, and Comparative Study of the ANNE™  
Sleep System versus Polysomnography to Diagnose Obstructive Sleep Apnea: ANNE 
Program for the Non-Invasive Evaluation of Apnea in Sleep (APNEAs)
Protocol Version: v1.1
Principal Investigator(s):  
Phyllis Zee MD PhD
Chief of Sleep Medicine
Northwestern Memorial Hospital
Professor of Neurology
Northwestern University Feinberg School of Medicine 
P: 312-503-4409
Email: p-zee@northwestern.edu
676 N St Clair St Arkes Pavilion, Ste 7-701, Chicago, IL 60611
Co-Principal Investigator(s): 
Charles Davies MD PhD
Program Lead, Sleep Medicine
Carle Foundation Hospital
Clinical Research Associate Professor
Carle Illinois College of Medicine
P: 217-383-3440
Email: Charles.Davies@carle.com
602 W University Ave, Urbana, IL 61801
Central DuPage Hospital (CDH). 
Kuljeet Gill MD
25 N Winfield Rd Ste 204, Winfield, IL 60190-1295
Email: KellyGill@northwestern.edu
P: 630-232-0202
Northwestern Lake Forest Hospital
Jennifer Cooksey, MD
676 N St Clair St, Ste 7-701, Chicago, IL 60611
Email: jessica.cooksey@northwestern.edu
P: 312-695-1800 
Sponsor:  
Sibel Inc
Representative: Peter Xu., MD, PhD.
6650 W Touhy Ave
Niles, IL 60714
P:  224-251-8859
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Confidentiality Statement
The information in this document contains information that is privileged or confidential and may 
not be disclosed unless such disclosure is required by applicable laws and regulations. In any 
event, persons to whom the information is disclosed must be informed that the information is 
privileged or confidential and may not be further disclosed by them. These restrictions on 
disclosure will apply equally to all future information supplied to you, which is indicated as 
privileged or confidential.
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Signature Pages
Principal Investigator(s):
                 
Name: Phyllis Zee MD PhD
        Date:
Title: Chief of Sleep Medicine
Northwestern Memorial Hospital
Professor of Neurology
Northwestern University Feinberg School of Medicine 
P: 312-503-4409
Email: p-zee@northwestern.edu
676 N St Clair St Arkes Pavilion, Ste 7-701, Chicago, IL 60611
Co- Principal Investigator(s):
      
Name: Charles Davies MD PhD
        Date:
Title: Program Lead, Sleep Medicine
Carle Foundation Hospital
Clinical Research Associate Professor
Carle Illinois College of Medicine
P: 217-383-3440
Email: Charles.Davies@carle.com
602 W University Ave, Urbana, IL 61801
Northwestern Lake Forest Hospital
Jennifer Cooksey, MD
1000 N Westmoreland Rd Pavilion B, Level 1, Lake Forest, IL 60045Email: 
jessica.cooksey@northwestern.edu
P: 847-535-7647
Central DuPage Hospital (CDH). 
Kuljeet Gill MD
25 N Winfield Rd Ste 204, Winfield, IL 60190-1295
Email: KellyGill@northwestern.edu
P: 630-232-0202
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Signature page
Sponsor:
      
Name: Peter Xu, MD, PhD
        Date:
Title: Sibel Health’s Chief Operating Officer
6650 W Touhy Ave
Niles, IL 60714
P:  224-251-8859
Email: peter.xu@sibelhealth.com
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PROTOCOL SUMMARY
Protocol Title (Long 
Title)
A Single Arm, Open-Label, Multi-Center, and Comparative Study of 
the ANNE™  Sleep System versus Polysomnography to Diagnose 
Obstructive Sleep Apnea: ANNE Program for the Non-Invasive 
Evaluation of Apnea in Sleep (APNEAs)
Protocol Title (Short 
Title)
ANNE Program for the Non-Invasive Evaluation of Apnea in Sleep 
(APNEAs)
Protocol Number
TP-210216-01-A
Phase
Clinical Validation
Study Design
Single-Arm, Open Label, Multicenter, Comparative Study
Study Duration
Start: March 2021
End: December 2021
Setting
Multiple Centers:
1.
Carle Foundation Hospital 
2.
Northwestern Memorial Hospital (NMH)
3.
Northwestern Lake Forest Hospital
4.
Northwestern Medical Group (NMG)
5.
Central DuPage Hospital (CDH)
Sample Size
A total of approximately 214 subjects may be recruited to complete 
the study. All sites will aim to contribute an equal or similar number of 
subjects to contribute to the sample size.
Main Inclusion 
Criteria
●
22 years old or older
●
Subjects with suspected OSA based on history and physical who 
qualify for, and have PSG or HST ordered, as determined by their 
regular healthcare provider
●
Persons with a previous diagnosis of OSA
●
Subjects with self-reported symptoms of OSA
●
Willingness to give consent and comply with study procedures
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Primary Objectives:
The main objective of this study is to evaluate the accuracy of the 
ANNETM Sleep system to serve as a diagnostic aid for moderate to 
severe obstructive sleep apnea (OSA) in adults. Our primary 
hypothesis is that the ANNETM Sleep system is non-inferior compared 
to polysomnography (PSG) for the diagnosis of moderate to severe 
OSA. 
Investigational 
Product and Planned 
Use
ANNETM Sleep System
Statistical Analysis
The apnea-hypopnea index (AHI) will be calculated in ranges of 15 – 
30 apnea/hypopnea events per hour for moderate OSA and ≥30 
apnea/hypopnea events per hour for severe OSA. The oxygen 
desaturation index (ODI), the hourly average number of desaturation 
episodes, will also be calculated. The accuracy (sum of the number of 
true positives and true negatives divided by the sum of the number of 
true positives, true negatives, false positives, and false negatives), 
sensitivity, specificity, positive predictive value, and negative 
predictive value of ANNE™ Sleep to detect moderate to severe 
obstructive sleep apnea will be compared to outputs from PSG.
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Table of Contents
1. LIST OF ABBREVIATIONS
9
2. OBJECTIVES
11
3. INTRODUCTION
11
4.  STUDY ENDPOINTS
12
4.1 Primary Outcome Measures
12
4.2 Exploratory measures
12
5.  RECRUITMENT METHODS
12
5.1 Recruitment centers
12
5.2 Recruit procedures
12
5.2.1 Screening potential patients
12
5.2.2 Assess eligibility of subjects for the study
13
5.2.3 Informed Consent Form (ICF)
13
5.2.4 Subject Screening/Enrollment Log
13
5.3 Recruitment monitoring
13
6.0 INCLUSION AND EXCLUSION CRITERIA
14
6.1 Inclusion Criteria
14
6.2 Exclusion Criteria
14
7.  STUDY INVESTIGATIONAL DEVICE
14
ANNE™ Sleep system
14
8.  PREPARATION OF ANNE™ SLEEP SYSTEM
15
8.1 Standard study supply kit
15
8.2 Study Kit Cleaning
16
9.  STUDY PROCEDURES
17
9.1 Pre-study
17
9.2 Study procedures
17
9.2.1 PSG procedures
17
9.2.2    ANNETM Sleep procedures
18
9.2.3    Completion of PSG/ANNE Sleep Study
19
9.2.4    Checklist for scheduled events
20
10. SCORING
20
11.  STATISTICAL ANALYSIS
23
11.1 Determination of Sample Size
23
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11.2 Power Calculation
23
11.3 Disposition of Subjects
23
11.4 General Methodology
24
11.5 Exploratory measurements for research purposes
24
11.6 Data Analysis Presentation
25
11.6.1  Center Pooling
25
11.6.2 Handling of Missing Data and Dropouts
25
11.6.3 Major Protocol Deviations
26
11.6.4 Adjustments for Multiple Comparisons
26
11.6.6 Primary Endpoint
26
11.6.7 Safety Evaluation
27
12. COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
27
13.  WITHDRAWAL OF PARTICIPANTS
27
14.  RISKS TO PARTICIPANTS
27
15.  ADVERSE EVENTS
28
16.  POTENTIAL BENEFITS TO PARTICIPANTS
29
17.  DATA MANAGEMENT AND PARTICIPANT CONFIDENTIALITY
29
17.1 SOURCE DOCUMENTS AND CASE REPORT FORM COMPLETION
29
17.2 CONSENT PROCESS (ALL PARTICIPANTS)
30
17.3 PARTICIPANT CONFIDENTIALITY
30
17.4 ADDITIONAL PRIVACY NOTE
30
17.5 PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
31
18. MULTI-SITE RESEARCH
19.  PROTOCOL DEVIATIONS
31
20.  NON-ENGLISH SPEAKING PARTICIPANTS
31
21.  GOOD CLINICAL PRACTICE
31
22.  INSTITUTIONAL REVIEW BOARD (IRB)
31
23.  REFERENCES
33
APPENDIX A - PHONE RECRUITMENT SCRIPT
35
APPENDIX B - EMAIL RECRUITMENT SCRIPT
37
APPENDIX C – PATIENT RECRUITMENT FLYERS
38
Flyer 3 (Facebook or other localized social media)
39
APPENDIX D - STOP-BANG QUESTIONNAIRE
40
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APPENDIX E - SLEEP DIARY
43
APPENDIX F – PATIENT SURVEYS
44
APPENDIX G - INFORMED CONSENT FORM (ICF)
47
47
APPENDIX H - STUDY KIT CLEANING INSTRUCTION
57
APPENDIX I – DEMOGRAPHIC, MEDICAL HISTORY AND SLEEP SURVEY
58
1. LIST OF ABBREVIATIONS
AASM 
American Academy of Sleep Medicine
AHI  
Apnea-Hypopnea Index 
CDH
 
Central DuPage Hospital
ECG
Electrocardiogram
EDF 
European Data Format
EDW  
Electronic Data Warehouse
EHR 
 
Electronic Health Record
EMG
Electromyography
FAS
Full Analysis Set
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act of 1996
HR
Heart Rate
HST 
Home Sleep Test
ICF  
Informed Consent Form
ICH-GCP
International Conference on Harmonization Good Clinical Practice
IRB  
Institutional Review Board
MRN  
Medical Record Number
NMG  
Northwestern Medical Group
NMH  
Northwestern Memorial Hospital
NPV  
Negative Predictive Value
OSA 
 
Obstructive Sleep Apnea 
ODI  
Oxygen Desaturation Index
PAP
Positive Airway Pressurewas
PAT
Peripheral Arterial Tonometry
PHI
Protected Health Information
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PI
Principal Investigator
PPAS
Per Protocol Analysis Set
PPV 
 
Positive Predictive Value
PSG
 
Polysomnography
PTT
Pulse Transit Time
RPSGT
Registered Polysomnography Technicians
RR
Respiratory Rate
SDB
Sleep Disordered Breathing
SL
Sleep Latency
SoC
System-on-Chip
TRT
Total Recording Time
TST
Total Sleep Time
WASO
Wake after sleep onset
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2. OBJECTIVES
The main objective of this study is to evaluate the accuracy of the ANNETM Sleep system to serve 
as a diagnostic aid for moderate to severe obstructive sleep apnea (OSA) in adults. Our primary 
hypothesis is that the ANNETM Sleep system is non-inferior compared to polysomnography (PSG) 
for the diagnosis of moderate to severe OSA. 
3. INTRODUCTION 
Sleep disordered breathing (SDB) is an increasingly common disorder characterized by a 
pathological increase in upper airway resistance experienced during sleep that ranges from 
benign snoring to its most severe form of obstructive sleep apnea (OSA). OSA is characterized 
by recurrent episodes of cessation of breathing and physiological stress as a result of intermittent 
periods of hypoxemia, and arousals. Studies have demonstrated that OSA leads to profound 
sleep fragmentation, disturbance of the autonomic nervous system, insulin resistance, increased 
systemic inflammation, oxidative stress, and subsequent vascular endothelial dysfunction. These 
physiologic changes cause significant morbidity; OSA is an independent risk factor for wide 
ranging adverse health outcomes including cardiovascular disease (hypertension, stroke, 
myocardial infarction), metabolic disorders (insulin insensitivity, diabetes), neurological 
(dementia), motor vehicle accidents, and mood disorders.1-5 
The ANNETM Sleep system has been validated in multiple clinical studies including a pilot 
investigation of its performance against a Type III Home Sleep Apnea Test (HST). In controlled 
clinical testing scenarios (n=13) with breathe-down studies of gases with lower and lower amounts 
of oxygen to induce hypoxia, the system has validated heart rate, respiratory rate, and oxygen 
saturation (SpO2) against gold-standard monitoring systems. The average root mean square error 
(ARMS) is <1 heart beats per minute, 2.9% blood oxygenation, and 1.3 breaths per minute. The 
ARMS in the pediatric population (>150 subjects) is <2.5 heart beats per minute, 2.9% blood 
oxygenation, and 1.9 breaths per minute. In a comparison study of ANNETM Sleep vs HST in n=46 
high-risk individuals, the sensitivity of 85% and specificity of 95% for the diagnosis of moderate 
to severe OSA was defined by an apnea-hypopnea index >15. The system is indicated for 
detection limits as follows:
●
Heart rate: 0 to 300 beats per minute
●
Respiratory rate: 0 to 60 breaths per minute
●
Oxygen Saturation (SpO2): 70 – 100%
In this context, this study is designed to evaluate the accuracy of the ANNETM Sleep system to 
serve as a diagnostic aid for moderate to severe OSA.
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4.  STUDY ENDPOINTS
4.1 Primary Outcome Measures
The diagnosis of moderate to severe OSA by determining a patient’s Apnea-Hypopnea Index 
(AHI) using the ANNETM Sleep system compared to Polysomnography (PSG) over one (1) night 
worn concurrently.
4.2 Exploratory measures
The following subset of exploratory measures are intended to provide additional information. A 
full list is provided in section 11.5.

Evaluation of the predictive value of the ANNETM Sleep system to differentiate obstructive vs 
central apnea events using the system’s onboard sensors

Patient reported preferences between PSG and ANNETM Sleep

Patient reported survey results for the ANNETM Sleep system
5.  RECRUITMENT METHODS
5.1 Recruitment centers
Study subjects will be recruited in 4 centers if they self-report symptoms of OSA or are 
prescribed either a PSG or HST by their regular healthcare provider when OSA is suspected 
from one of the following study sites: 
1) Carle Foundation Hospital 
2) Northwestern Memorial Hospital (NMH)
3) Northwestern Lake Forest Hospital
4) Northwestern Medical Group (NMG)
5) Central DuPage Hospital (CDH)
5.2 Recruitment procedures 
All recruiting processes will follow this protocol and meet the inclusion and exclusion criteria. 
Recruitment will occur in via two main strategies. The first will be community based and clinic 
based advertisements via social media ads, and physical fliers. The second will be center based 
recruitment via Electronic Health Records (EHRs).
5.2.1 Screening potential patients
A study coordinator may flag orders for PSG or HST studies via screening of EHRs. An algorithm 
will be set up based on the eligibility criteria of the trial to identify potential patients who have met 
enrollment criteria to establish a roster of potential subjects to be recruited. Study subjects who 
have a previous diagnosis of OSA or self-reported OSA symptoms may be enrolled in the study.
For all Northwestern Hospitals, additional methods of identifying participants will be through the 
Electronic Data Warehouse (EDW) and through the use of study flyers and recruitment materials. 
The EDW at Northwestern is updated daily. An algorithm can be set up based on the eligibility 
criteria of the trial to identify potential participants that have met enrollment criteria. Data gathered 
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in the EDW request will include Name, contact information (address, email and/or phone), Date 
of Birth, MRN, hospitalization date(s), and if applicable, date that a HST or PSG is ordered. The 
EDW request may exclude people based on the exclusion criteria. The use of the EDW will be 
used exclusively for recruitment purposes and no data from the warehouse will be added to the 
study data set for research analysis. The use of study flyers or advertisements will also be shared 
with potential study subjects who will be given contact information to follow up with the study 
team. For Carle Foundation Hospital, the site may utilize MyCarle, a patient database, to locate 
and contact potential participants using the approved scripts (Appendix A & B).
5.2.2 Assess eligibility of subjects for the study
Potential subjects will be further screened for eligibility per the inclusion/exclusion criteria. A study 
coordinator will contact potential subjects either in person or by phone and provide an overview 
of the study using an approved phone script (Appendix A), email (Appendix B), or patient 
recruitment flyer (Appendix C). The screening questionnaire will be asked during phone 
interviews and or email. An additional tool for screening study subjects will be completed with the 
use of the STOP-BANG questionnaire and Epworth Sleepiness Scale (Appendix D) and 
screening questions which may be done over the phone, in-person, or using a link to an electronic 
survey. 
5.2.3 Informed Consent Form (ICF)
If a subject is deemed eligible, the study coordinator will explain that if they consent they will wear 
the ANNE Sleep during an attended PSG study for one (1) night.  The coordinator will also inform 
subjects that they will be asked to complete the Sleep Diary log (Appendix E) during the morning 
following data collection and a patient survey at the end of the study (Appendix F). 
If subjects are interested in participating in the study, the subject will sign the IRB approved 
Informed Consent Form (ICF) (Appendix G). Subjects may provide an electronic signature via 
REDCap, a secure web application for building and managing online data capture for research 
studies. Study subjects may also be asked to be photographed in-person at the time of their PSG 
study to demonstrate and document the location of the ANNE™ Sleep sensors. 
5.2.4 Subject Screening/Enrollment Log
When a signed consent form is completed, the coordinator will obtain the subject’s medical history 
from the EHR and information including name, date of birth, address, telephone number, email, 
demographics, age, and sex. Each consented subject will be assigned a unique subject number. 
Subject numbers will not be reassigned or reused for any reason. Only their assigned subject 
number will identify subjects. The investigator must maintain a list of potential subjects and 
enrolled subjects using the Subject Screening/Enrollment Log.
5.3 Recruitment monitoring
Recruitment for all sites will be monitored carefully with weekly meetings between study 
coordinators and study investigators. Barriers to recruitment will be identified and addressed to 
ensure recruitment remains on track.
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6.0 INCLUSION AND EXCLUSION CRITERIA
Eligible participants will be screened using electronic medical records from their respective study 
sites. Eligible participants may also be screened over the phone. No special populations will be 
targeted for the enrollment in this study. Additional patient referrals will be made by the physicians 
who are participating as investigators on this study. The referring physicians of patients to the 
study will make an assessment if a potential study subject is capable of providing informed 
consent and will not refer patients unlikely to understand what is being asked of them. All potential 
subjects will be evaluated by research staff in order to match them to the inclusion and exclusion 
criteria that has been established.
6.1 Inclusion Criteria
1) ≥22 years old.
2) Subjects with suspected OSA based on history and physical who qualify for, and have 
either a PSG or HSAT ordered, as determined by their regular provider. Subjects with self-
reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative 
answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners 
who have observed the subject stopping breathing or choking/gasping during sleep. 
Persons with a previous diagnosis of OSA are also eligible.
3) Willingness to give written consent and comply with study procedures
6.2 Exclusion Criteria
1)  An unstable medical condition, acute or chronic, that in the opinion of the investigator 
puts the subject at health risks related to this trial or interferes with the clinical trial and 
data collection based on the opinion of the investigator, this includes but is not limited to: 
A. Significant cardiorespiratory disease: patients that are oxygen dependent, 
previous hospitalization for cardiorespiratory issues
B.
Respiratory muscle weakness due to a neuromuscular condition 
C.
Awake hypoventilation or suspicion of sleep related hypoventilation 
D. Chronic opioid medication use
E.
History of stroke 
F.
History of severe insomnia
2)  Inability to understand instructions
3)  Has an active skin abnormality that precludes assessment
4)  Has a history of dementia
5)  Patients with implanted pacemakers or defibrillators
6)  Subject is pregnant, nursing or planning a pregnancy over the expected course of the study
7.  STUDY INVESTIGATIONAL DEVICE
ANNE™ Sleep system
Sibel’s ANNE™ Sleep system includes two skin-mounted, bio-integrated sensors to record vital 
signs, a wireless charger, a wireless charger adaptor, single-use chest adhesives, single-use over 
the sensor adhesives, single-use finger adhesives, and a mobile device with a mobile software 
application that enables data recording for download for further analysis. 
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Heart rate (HR), respiratory rate (RR), actigraphy, and skin temperature are recorded from the 
ANNE™ Chest sensor. Blood oxygenation (SpO2), peripheral arterial tonometry (PAT), and skin 
temperature are recorded from the ANNE™ Limb sensor. PAT is indicative of vasoconstriction, 
which can serve as a proxy for respiratory disturbances and accepted by the American Academy 
of Sleep Medicine for use as part of home sleep testing. The ANNETM Sleep system also 
calculates pulse transit time (PTT), a measure of time for a pulse generated from the heart to 
travel to the peripheral limb. It is used as a surrogate marker of respiratory effort, apnea, and 
hypopnea events. 
The first sensor (chest unit) located on the chest contains a 3-axis gyroscope and 3-axis 
accelerometer, Bluetooth Low Energy System-on-Chip (SoC), a Lithium-Polymer battery, power 
management 
component, 
an 
analog 
front-end 
component, 
passive 
electrodes 
for 
electrocardiogram (ECG) and electromyography (EMG), bio-impedance feature for RR, and a 
temperature sensing unit.  
The second sensor (limb unit) located on the finger of a patient contains Bluetooth Low Energy 
SoC, a Lithium-Polymer battery, power management solution, low-power microcontroller, an 
analog front-end component, pulse oximeter (SpO2), and a temperature-measuring unit. 
The chest sensor is placed on the body via a single-use chest adhesive as well as an optional 
over the sensor adhesive. Both adhesives will be removed and discarded after one use. The limb 
sensor is held in place by a single-use finger adhesive, which is removed and discarded after one 
use, then replaced with a new finger adhesive.
Chest Unit
Limb Unit
Multi-Use
Figure 1.  The ANNE™ Sleep consists of 2 sensors, a chest unit worn on the thorax and a limb 
unit that wraps around a finger. 
8.  PREPARATION OF ANNE™ SLEEP SYSTEM
8.1 Standard study supply kit
The study sponsor will ship ANNE™ Sleep system (study supply kit) to the study centers.
Study supply kit list
●
Cardboard mailer box
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●
Wearable study sensors
●
Study devices (Tablet(s) or smart phone(s) with sensor application pre-loaded). 
●
Wireless charger(s), charger adaptors
●
Device accessories; chest adhesives, over the sensor adhesives, finger adhesives
●
Printed instructions or other study materials
The research coordinator from the sponsor will document tracking records of each device. All 
adhesives are single use with new ones provided to each new subject. 
8.2 Study Kit Cleaning
Study sensors are reusable after completion of study procedures and data collection. Used study 
kit containers will be wiped on the outside using Sani-Cloth before handling and placed in a fume 
hood labeled “Contaminated Study Kits”.
The below table lists materials and PPE for sanitation.
Table 1. (Part 1: Sanitation procedure for wearable study devices and device 
accessories)
Materials and PPE
Study supply kit list
●
70% ETOH
●
Super Sani-Cloth Germicidal 
Wipe*
●
Disposable paper towel
●
Nitrile Gloves
●
Lab coat
●
Face mask*
●
Cardboard mailer box. 
●
Wearable study sensors
●
Study devices (Tablet(s) or smart 
phone(s) with sensor application). 
●
Wireless charger(s), charger cords, 
bricks
●
Device accessories; adhesives for 
both sensors
●
Printed instructions or study other 
study materials
*Super Sani-Cloth is an EPA registered hospital-grade disinfectant to accommodate the many 
situations and hard non-porous environmental surfaces found in healthcare settings. 
This wipe kills bacteria, viruses and yeast.
*Face masks are to be used only if social distancing cannot be maintained.
The detailed sanitation instructions for the study kit are attached as APPENDIX G.
The study sponsor should perform an inspection of each device and ensure cleaning procedures 
should be conducted before shipping and after receiving the return shipment per guidance from 
the Center for Disease Control8. 
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9.  STUDY PROCEDURES
9.1 Pre-study 
The study coordinator will schedule a conversation, via phone or in person, with the potential 
study subjects.
To minimize the risk of loss of privacy and enhance confidentiality, the subject may have the 
option to discuss with the study coordinator over the phone or by a Zoom teleconference from the 
subject’s personal device. If Zoom communication is selected a unique meeting number and 
password known only to the subject will be provided. The study coordinator will monitor the 
number of attendees in the meeting and restrict meetings to IRB approved researchers on this 
study, the study subject, and additional people at the subject's discretion. Researchers will host 
the Zoom sessions and will utilize the waiting room feature to ensure that only the appropriate 
participants are included on the call.
The study coordinator will cover following topics associated with the study:
(1) The qualified subject will be asked to schedule a PSG study to operate concurrently with 
the ANNE™ Sleep system for one supervised night at the sleep center with the assistance 
of a study coordinator as needed. The target time frame will be to complete the sleep night 
within 2 weeks of enrollment and confirm when they will be completing the PSG night.
(2) Advise subjects to avoid alcohol and sleep medication use such as antihistamine (OTC) 
or prescribed medicines for sleep support on the testing night. Any use of these 
substances on the night of monitoring sleep will be asked to be recorded in the diary.
(3) Discuss with the subjects regarding the completion of the Demographic, Medical History 
and Sleep Survey (Appendix I) sleep diary (Appendix E) and usability survey (Appendix 
F). The sleep diary and usability survey should be available to complete via an email link 
through REDCap or printed out forms.
Any subject’s questions or concerns associated with the study will 
also be addressed. 9.2 Study procedures
The following summarizes the procedure subjects will go through during the PSG/ANNETM 
Sleep night. At least 24 hours prior to the subject’s PSG/ANNE™ Sleep study, the study 
coordinator will contact the participant by phone to confirm their scheduled appointment. Once 
confirmed, the study coordinator will meet the subject at their respective sleep health centers on 
the night of the PSG/ANNE™ Sleep study. 
9.2.1 PSG procedures
The subject should expect the following PSG procedures to be conducted by a sleep technician 
following established AASM practice parameters for PSG.
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1)
Subjects will follow all typical PSG procedures and wear all appropriate PSG 
equipment as instructed by their sleep technician. 
2)
Set up PSG
a) Electrodes placed on the scalp, outer edges of the eyes, and chin to record 
brain, heart and muscle activity, cannula for airflow, and eye movement; 
elastic belt around the chest and abdomen to monitor breathing; a sensor 
on the index finger to check oxygen levels in blood and heart rate.  
b) Subjects will also be videotaped while they sleep to review any changes 
observed during the PSG study.
3)
The data collection for PSG procedures
The data collection during the study night will be handled by the sleep technician. 
After a full night of data collection, the data will be stored in a secure and private 
database designated in the respective sleep laboratories. 
9.2.2    ANNETM Sleep procedures
After PSG equipment is applied, the ANNE™ Sleep will be applied on the subject by the principal 
investigators (PIs) or study coordinators. 
1)
The PI or study coordinator will ensure the ANNE™ Sleep sensors are functional 
and collecting data properly.  The study coordinator will provide instructions for use 
of the ANNE™ Sleep system to the sleep technician as well. 
2)
Place sensors on subjects
The subject should expect the following ANNE™ Sleep procedures to be 
conducted by the PI or study coordinator: 
a)
Using IPA alcohol wipes, the areas on the skin where the sensors will be 
placed will be wiped down thoroughly to remove any dirt, oils, etc. IPA 
alcohol wipes will be used to clean the surface of the sensors before 
placement. If necessary, the chest may be shaved to provide better 
adhesion and comfort of the sensor.  
b)
A single use adhesive will be applied to the chest sensor and placed on the 
subject’s chest at the suprasternal notch (see Figure 2). When the chest 
sensor is placed, an over the sensor adhesive will be applied around the 
sensor as well to enhance the adhesion of the sensor to the subject. The 
limb sensor will be attached to the subject’s finger using a single-use 
adhesive (see Figure 2).
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Figure 2.  Placement of the ANNETM chest and limb sensors
3) Photographs of the ANNE™ Sleep sensors on the subjects will be obtained in-person 
at the time of the PSG study to demonstrate and document the location of the ANNE™ 
Sleep sensors.  Photographs will be taken by research personnel with a research-
dedicated mobile phone. Photographs will not include the patients face or identifying 
features. All photographs will be stored on a secure server maintained by the study 
team and will be labeled with a unique subject study number. 
4) Set up a mobile device with an ANNE Sleep application
a)
The ANNE™ Chest and ANNE™ Limb sensors are paired with the ANNE 
Sleep mobile application by following the instructions on mobile device
b) 
After checking that the sensors are placed correctly and the signal quality 
is adequate, subjects will then proceed to sleep. 
5)  Data collection and storage
a)
After a full night of data collection, data will be collected through the ANNE 
Sleep application by downloading the data from the sensor through 
Bluetooth.
b)
The data will be uploaded automatically to ANNE™ Hub, a secure data 
repository from the application, and will be associated with the subject ID.
c)
The data will be stored in an EDF data format for further analysis.
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9.2.3    Completion of PSG/ANNE Sleep Study
(1)
After completing data collection, subjects will complete their sleep diary (Appendix 
D) and be given surveys (Appendix E) to complete in print material or by email 
link via REDCap.
(2)
Once the surveys are complete, the study coordinator will let the subject know that 
their participation is complete. A compensation gift card will then be mailed to the 
subject’s home address or given to them in-person.
(3)
After completing the PSG/ANNE™ Sleep study night, the study coordinator will 
have a phone call with the subject or discuss in person to confirm testing was 
successful and address any issues if needed. 
After review of sleep technician’s report, study coordinator will send 
out risk letter to subject if applicable. Study physician will review study 
and/or follow-up with subject’s physician regarding critical values as 
medically necessary. 9.2.4    Checklist for scheduled events
             The study coordinator should review the schedule of events, summarized below:
Initial Visit Day: 
Screening/
Enrollment
PSG/ANNETM 
Sleep  night
End of Study*
Eligibility
X
Consent
X
Demographics, Medical Hx 
and Sleep Survey
X
ANNETM Sleep
X
PSG
X
Photos of ANNETM Sleep 
on Subject
X
Sleep Diary
X
Phone follow-up (which 
may occur up to 1 week 
after the study)
X
Usability Survey
X
Adverse Events
X
X
        * Immediately following the PSG test night 
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10. SCORING
10.1 PSG Scoring
The data from PSG will be reviewed and scored for sleep staging and respiratory events by 3 
registered polysomnography technicians (RPSGT) who are blinded to the experimental 
condition, the scoring of the ANNETM sleep system, and represent scorers in clinical practice in 
AASM accredited sleep disorder centers. In order to minimize interscorer variability, the 
technicians will have >85% concordance and to ensure quality and reproducibility, a board 
certified sleep medicine physician who is blinded to the experimental condition will review all 
raw PSG data If AHI determined from PSG do not meet the 85% concordance between three 
RPSGTs, a board-certified sleep medicine physician will provide the final determination of the 
AHI.
Scoring of PSG data will follow guidelines established by the American Academy of Sleep 
Medicine Manual for the Scoring of Sleep and Associated Events (v2.6)6. Sleep scoring includes 
the following variables: clock time (hr:min) of lights off and lights on; total recording time (TRT= 
duration in minutes from lights off to lights on); total sleep time (TST= time in minutes spent in 
sleep stages N1 + N2 + N3 + REM); sleep latency (SL= time in minutes from lights off to the first 
epoch of any sleep stage); REM latency (time in minutes from lights off to the first epoch of 
REM sleep); wake after sleep onset (WASO= duration in minutes of TRT minus TST minus SL); 
sleep efficiency (SE= TST/TRT*100%); time in minutes in each sleep stage (N1, N2, N3 and 
REM sleep); percentage of time spent in each sleep stage (time in minute in each stage/TST 
*100%). Arousal events are quantified as total number of arousals and as arousal index (AI= 
number of arousals x 60/TST). The scoring of respiratory events to evaluate for sleep 
disordered breathing will also follow AASM scoring rules. The thermistor will be used for scoring 
apneas, and the pressure transducer and pulse oximetry will be used for scoring hypopneas. 
Chest and abdominal belts will be used to determine apnea type. 
The apnea-hypopnea index (AHI) will be calculated in ranges of 15–30 apnea/hypopnea events 
per hour for moderate OSA and ≥30 apnea/hypopnea events per hour for severe OSA. The 
oxygen desaturation index (ODI), the hourly average number of desaturation episodes, will also 
be calculated based on similar criteria. 
An apnea event is defined when BOTH of the following criteria are met: 

There is a drop in the peak signal excursion by ≥90% of pre-event baseline using an 
oronasal thermal sensor (diagnostic study), PAP device flow (titration study) or an 
alternative apnea sensor (diagnostic study). 

The duration of the ≥90% drop in sensor signal is ≥10 seconds
Hypopnea is defined when ALL of the following criteria are met:

The peak signal excursions drop by ≥30% of pre-event baseline using nasal pressure 
(diagnostic study), PAP device flow (titration study), or an alternative hypopnea sensor 
(diagnostic study).

The duration of the ≥30% drop in signal excursion is ≥10 seconds.

There is a ≥4% oxygen desaturation from pre-event baseline.
AHI will be calculated manually by its standard formula—AHI = apneas + hypopneas * 60/TST).:
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𝑻𝒐𝒕𝒂𝒍 𝑵𝒖𝒎𝒃𝒆𝒓 𝒐𝒇 𝑨𝒑𝒏𝒆𝒂 𝑬𝒗𝒆𝒏𝒕𝒔 +  𝑻𝒐𝒕𝒂𝒍 𝑵𝒖𝒎𝒃𝒆𝒓 𝒐𝒇 𝑯𝒚𝒑𝒐𝒑𝒏𝒆𝒂 𝑬𝒗𝒆𝒏𝒕𝒔
𝑻𝒐𝒕𝒂𝒍 𝑵𝒖𝒎𝒃𝒆𝒓 𝒐𝒇 𝑴𝒊𝒏𝒖𝒕𝒆𝒔 𝑨𝒔𝒍𝒆𝒆𝒑
× 𝟔𝟎
10.2 ANNETM Sleep Scoring
The data from ANNETM will be reviewed and scored for respiratory events by 3 registered 
polysomnography technicians (RPSGT) who are blinded to the scoring of the PSG, and 
represent scorers in clinical practice in AASM accredited sleep disorder centers. An average will 
be taken of the three scores. In order to minimize interscorer variability, the technicians will have 
>85% concordance and to ensure quality and reproducibility, a board certified sleep medicine 
physician who is blinded to the experimental condition will review all raw PSG data. If AHI 
determined from ANNETM Sleep exhibits greater than 20% difference between three RPSGTs, a 
board-certified sleep medicine physician will provide the final determination of the AHI.
Scoring of ANNETM Sleep data will follow guidelines established by the American Academy of 
Sleep Medicine Manual for the Scoring of Sleep and Associated Events (v2.6)6. Sleep scoring 
includes the following variables: total recording time (TRT= duration in minutes from sensor 
activation to sensor disconnection). The scoring of respiratory events to evaluate for sleep 
disordered breathing will also follow AASM scoring rules. 
The ANNETM Sleep will be scored similarly with the system’s onboard sensors as an alternative 
hypopnea and apnea sensor via PAT. The definition of mild, moderate, or severe obstructive 
sleep apnea is based on AHI.
●
AHI < 5: Normal 
●
AHI ≥ 5 – <15: Mild 
●
AHI ≥15 – <30: Moderate 
●
AHI ≥ 30: Severe
The AHI calculated from ANNETM Sleep will be considered an estimation of AHI, coined as Sibel-
AHI.
An apnea event is defined as: 
●
A drop in peak signal excursion by ≥ 90% of pre-event baseline for ≥ 10 seconds using an 
oronasal thermal signal, PAP device flow, or an alternative apnea sensor. 
●
No requirement for a desaturation or an arousal
Hypopnea will be defined by:
●
The peak signal excursions drop by ≥30% of pre-event baseline using nasal pressure 
(diagnostic study), PAP device flow (titration study), or an alternative hypopnea sensor 
(diagnostic study)
●
The duration of the ≥30% drop in signal excursion is ≥10 seconds
●
There is a ≥4% oxygen desaturation from pre-event baseline and/or the event is 
associated with an arousal
The scoring of respiratory events to evaluate for sleep disordered breathing will also follow 
AASM scoring rules. Apnea-hypopnea index will be used to determine the presence and 
severity of sleep apnea (AHI= apneas + hypopneas *60/TRT). 
The accuracy (sum of the number of true positives and true negatives divided by the sum of the 
number of true positives, true negatives, false positives, and false negatives), sensitivity, 
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specificity, positive predictive value, and negative predictive value of the ANNE™ Sleep to detect 
moderate to severe obstructive sleep apnea will be compared to outputs from PSG.
11.  STATISTICAL ANALYSIS 
11.1 Determination of Sample Size 
The sample size determination is based on the primary endpoint of determining the ANNETM Sleep 
system’s diagnostic test characteristics (sensitivity and specificity) when compared to the gold 
standard, PSG for AHI. The calculations are based on parameters derived from a pilot program 
conducted in a similar patient population of subjects (n=46) who self-reported symptoms of OSA 
based on the STOP-BANG questionnaire. In this program, an overall prevalence of moderate to 
severe sleep apnea was 58%. We assume that the patient population from which this current 
study will be recruited will have a similar burden of moderate to severe OSA. We assume the 
prevalence to be 50% given that broader community outreach may reduce the total prevalence of 
moderate to severe OSA in our final cohort. For the primary objective, we will compare the 
sensitivity, specificity, positive predictive value, and negative predictive value of ANNETM Sleep 
against the gold standard of diagnosis, the PSG for the diagnosis of moderate to severe OSA. 
11.2 Power Calculation
Power Calculation Assumptions for Primary Endpoint of Sensitivity:
●
Prevalence of moderate to severe OSA in the population = 50%
●
H0: sensitivity of 80%
●
HA: sensitivity of 90%
A total of approximately 214 subjects may be recruited to complete the study. A minimum sample 
size of 164 subjects will be required to achieve a minimum power of 80% (actual power = 80.6%) 
in order to detect a change in the percentage value of sensitivity greater than or equal to 0.80, 
based on a target significance level of 0.05. 
Power Calculation Assumptions for Primary Endpoint of Specificity:
●
Prevalence of moderate to severe OSA = 50%
●
H0: specificity of 80%
●
HA: specificity of 90%
A minimum sample size of 164 subjects will be required to achieve a minimum power of 80% 
(actual power = 80.6%) in order to detect a change in the percentage value of specificity greater 
than or equal to 0.80, based on a target significance level of 0.05. Assuming a PSG and/or 
ANNETM Sleep failure rate of 10% of study subjects, the target sample size is 181.259 E.. Erie, 
Lavin, 
The power analysis was conducted in the statistical software PASS v15.0.11 following established 
statistical references.9-12 
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11.3 Disposition of Subjects 
Disposition status of the enrolled patients (Full Analysis Set) will be summarized using 
frequencies and percentages. Frequency and percentage of FAS patients with full follow-up will 
be reported, as well as patients with early withdrawal from the study, and the related reasons. 
The following disposition status for subjects will be summarized overall and by group:
1) Number and percentage of subjects in each FAS and per protocol analysis set (PPAS) 
analysis population
2) Number and percentage of subjects who completed the study/withdrew from the study 
(and reasons for premature discontinuations)
Analysis Sets
Two analysis sets will be created for study purpose: 
Full Analysis Set (FAS). FAS includes all enrolled subjects (those who signed the informed 
consent and who satisfied the eligibility criteria). FAS will be used for subjects’ disposition, 
population description, and for Safety analysis.
The PPAS is a subset of the FAS, restricted to subjects who adhere to the protocol and complete 
the PSG sleep night and ANNE sleep night concurrently without technical failures. The PPAS will 
be used for the performance analyses. The PPAS will serve as the primary analysis for the 
performance endpoints. If the FAS population is different from the PPAS population, then the 
analyses will be repeated for the FAS population. 
11.4 General Methodology
Continuous variables will be summarized using tables of descriptive statistics: number of patients 
with recorded observations, mean, standard deviation, median, minimum and maximum. 
Categorical variables will be summarized using counts and percentages. Descriptive statistics will 
be presented by diagnosis and clinical center. Diagnostic outcomes will be tabulated and 
compared for ANNETM Sleep vs PSG. 
11.5 Exploratory measurements for research purposes
Additional statistical analyses will be performed to compare outputs of AHI between the different 
systems. Specifically, these analyses include:
1) Evaluation of the predictive value of the ANNETM Sleep system to differentiate 
obstructive vs central apnea events using the system’s onboard sensors
2) Linear regression to establish correlation between AHI determined by ANNETM Sleep vs 
PSG on the same night
3) Bland-Altman plots will be created to establish bias and 95% confidence intervals of 
agreement between AHI determined by ANNE™ Sleep and PSG.
4) Summary statistics of the sensitivity, specificity and accuracy of the classification of the 
severity of OSA (normal, mild, moderate, and severe OSA) determined by AHI between 
PSG vs ANNETM Sleep.
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5) Accuracy analysis between AHI determined by ANNETM Sleep vs AHI determined by PSG 
on the same night.
6) Descriptive analysis of patients’ characteristics and assessments (e.g. sleep diary) before 
and after study procedures. Patient characteristics include age, gender, ethnicity, race, 
height, weight, baseline vital signs, relevant medical and surgical co-morbidities will be 
abstracted from the medical record or by direct survey of the participants. (Appendix I)
7) Descriptive and comparative analysis of safety parameters related to between ANNETM 
Sleep and PSG.
Parameters ascribed to the safety of patients will be summarized by diagnosis and clinical center. 
All available data from patients who fail to complete this study will be included in all safety 
summaries. Accuracy analysis will be run to provide % of agreement (overall, positive and 
negative agreement) between both procedures, p-value and 95% confidence interval. Correlation 
analysis (between two quantitative parameters) will be run: Pearson coefficient, p-value and 95% 
confidence interval will be calculated.
For other analyses:
●
Continuous variables will be summarized using descriptive statistics, specifically the 
mean, standard deviation, median, minimum and maximum. Comparison of continuous 
parameters between two groups will be performed using T-test or Wilcoxon Mann-Whitney 
U test, or Wilcoxon signed rank test (non-parametric) for paired data, as appropriate.
●
Categorical variables will be summarized using frequencies and percentages, and 
compared between two groups using Chi-Square or Fisher exact test, or Mac Nemar Chi- 
square test for paired data, as appropriate.
●
Subject disposition and follow-up, as well as demographic and baseline characteristics of 
patients, or to any questionnaire will be described for each clinical center in the follow up 
phone call within 1 week of completing the study.
11.6 Data Analysis Presentation
All data analysis will be performed by HealthCore Inc. Statistical programming and analyses will 
be performed using SAS Version 9.4 or higher. Raw data (i.e., minimum and maximum values 
presented for range in continuous variables) will be reported out to the precision with which it 
was collected. Means will be reported to 1 decimal place more than the raw data. SD will be 
reported to 1 decimal place more than the mean. Percentages will be reported to 1 decimal 
place. Trailing zeros will be presented to maintain a consistent level of precision, e.g. 2.0 rather 
than 2. All p-values will be rounded to 3 decimal places. If a rounded p-value is 0.000 (i.e., the 
actual p-value is less than 0.0005), then the p- value will be presented as ‘p< 0.001.’ 
The listings, specifically adverse events and major protocol deviations, will be ordered by site, 
subject and visit as applicable, unless otherwise stated. 
11.6.1 Center Pooling 
Descriptive statistics will be presented by diagnosis and clinical center. Parameters ascribed to 
the safety of patients will be summarized by diagnosis and clinical center. 
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11.6.2 Handling of Missing Data and Dropouts 
Missing data will not be imputed and excluded from calculations. A summary of missing data will 
be provided according to the number of subjects, the time points where the data are missing and 
the clinical center. For each clinical center, number and percent of subjects with no missing data 
will be presented in tabular form. All final variables will undergo assessments of missingness to 
ensure that there is no systematic pattern of missing data. 
11.6.3 Major Protocol Deviations 
Major protocol deviations will be summarized by type (e.g. informed consent, inclusion or 
exclusion criteria error, unreported serious adverse events (SAEs), treatment violation, study visit 
not per protocol, other). In addition, any patient-specific protocol deviations will be listed for each 
subject. Each individual site will record protocol deviations. 
11.6.4 Adjustments for Multiple Comparisons 
No adjustment will be made. 
11.6.5 Demographics and Baseline Characteristics 
Patients’ characteristics and other baseline data will be summarized (see section 11.3 General 
Methodology). 
11.6.6 Primary Endpoint
Analysis of the primary endpoint will evaluate the accuracy of the ANNETM Sleep system as a 
diagnostic aid of moderate to severe OSA via AHI derived from both systems based on the gold 
standard, PSG. Sensitivity is defined as the number of true positives divided by the sum of the 
number of true positives and the number of false negatives. Specificity is defined as the number 
of true negatives divided by the sum of the number of true negatives and the number of false 
positives. Positive predictive value (PPV) is defined as the proportion of people with a test result 
who actually have the disease: the number of true positives divided by the sum of the number of 
true positives and the number of false positives. Negative predictive value (NPV) is defined as 
the proportion of those with a negative test result who do not have the disease: the number of 
true negatives divided by the sum of the number of true negatives and the number of false 
negatives. Evaluation of the ANNETM Sleep System as a diagnostic tool for moderate to severe 
OSA will be assessed based on the following criteria:
●
A goal of sensitivity and specificity of greater than 80% in diagnosing moderate or 
severe OSA in comparison with the ANNETM Sleep against PSG.
●
PPV and NPV will be calculated along with 95% confidence intervals.
PSG: AHI ≥15
PSG: AHI <15
ANNE Sleep: AHI ≥15
True Positive
False Positive
ANNE Sleep: AHI <15
False Negative
True Negative
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11.6.7 Safety Evaluation
Adverse events should be assessed in terms of their seriousness, duration, intensity, and 
relationship to the study and use of the study device. All anticipated and unanticipated adverse 
events will be collected. Subjects will be able to contact the investigator at any time during the 
study if they note any change in their medical condition. The outcome of each adverse event will 
be observed and documented. Safety analysis, including adverse events and device deficiencies’ 
incidence and description will be run on FAS only.
12. COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
Subjects will receive $150 in gift cards for their time and effort. Compensation will be given to 
participants directly or mailed to the participant’s home within 3 weeks after study completion 
(which includes participating in a PSG and wearing ANNE™ Sleep for one night and completing 
the diary and usability survey). 
The cost of the PSG will be covered by the research study unless ordered as Standard of Care 
and approved by the study subjects’ insurance provider. Participants will not be informed of the 
results of this research. 
13.  WITHDRAWAL OF PARTICIPANTS
Participants may end their participation at any time during the study. The study investigators may 
choose to withdraw a study subject if he or she is unable to use the devices or complete the 
survey and diary. The study investigators may withdraw a patient if they develop skin sensitivity 
or have a medical complication that precludes wearing of the sensors on the suprasternal notch. 
If a subject is withdrawn from the study, they will be asked to return the study kit that is given to 
them at the start of the study. Unless specifically requested in writing, researchers will maintain 
and use data from patients that end their participation early. 
14.  RISKS TO PARTICIPANTS
Risk category: minimal
Potential risk: There is a risk of skin irritation or allergic reaction to the ANNE™ Sleep sensors.  
The devices will be placed on skin epidermis without conductive gel, thereby minimizing the risk 
of any skin irritation or allergic reaction. In addition, there will be no skin preparation except the 
use of a sterile alcohol pad (provided) to gently exfoliate the dead skin cells or dirt on epidermis. 
The adhesives have passed both biocompatibility, skin sensitization and cytotoxicity testing.
There is a risk of Protected Health Information (PHI) disclosure. Subject data will be de-identified 
and stored securely to prevent PHI disclosure.
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Any adverse events during the PSG will be addressed by the sleep technicians in accordance 
with the sleep lab’s standard procedure for handling adverse events. Any unique risks associated 
with the investigational sensors (as above) will be addressed by the study investigator and inform 
the sleep technicians of these risks prior to the PSG. The sleep technicians will be instructed to 
contact the study investigator if any skin irritation or allergic reactions occur.  If significant, the 
study will be terminated and usual medical care will be provided.
Protection against risks: there is a high probability OSA subjects will be closely monitored by sleep 
technicians during their sleep study to avoid adverse events.  The ANNE™ Sleep sensors will be 
removed if associated with significant discomfort or rash.  
SURVEY/DIARY: Some questions may make subjects uncomfortable or upset. Subjects do not 
have to answer these questions if they do not want to.
15.  ADVERSE EVENTS
The PI will determine whether adverse events are related to the study or unrelated to the study. 
The length of the study will be 1 night determined by the completion of the PSG night with the 
sensor concurrently. All serious adverse events – even if not deemed to be study-related – will be 
reported to the IRB. This includes a participant’s death, life-threatening condition, hospitalization, 
or disability. All study-related adverse events determined by the PI as serious will be recorded 
and reported to the IRB and the sponsor within 1 business day. Serious study-related adverse 
events are defined as adverse skin effects that warrant prescription medical therapy, skin tears 
leading to bleeding or an open wound, or skin burns. Study-related adverse events will be 
recorded on the adverse event form. If participation is discontinued, the timing of this will be 
recorded. Adverse events or protocol deviations that will be reported include, but are not limited 
to the following:
●
Skin related irritation or injury related to application or removal of the sensor.
●
Any evidence of discomfort during device use will be recorded by observation and by 
interview of the subject.
●
Human subjects research conducted without IRB approval.
●
Research personnel do not obtain written consent or assent for a study when the IRB has 
determined that consent or assent is required. While no harm occurred, failure to obtain 
consent/assent is a violation of the research participant’s rights.
●
Enrollment of participants before IRB approval has occurred and/or after IRB approval has 
lapsed.
●
Continued treatment of participants after IRB approval has lapsed without first obtaining 
permission from the IRB.
●
PI enrolls a participant that does not meet all of the inclusion/exclusion criteria. The criteria 
that were not met puts the participant at risk of harm.
●
Enrollment of children, prisoners, pregnant women and fetuses, without prior IRB 
approval.
●
Use of an unapproved consent form.
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●
Use of unauthorized study personnel to conduct study procedures, obtain informed 
consent, or have access to identifiable participant information.
●
Assessment for any inclusion/exclusion criterion was not done prior to beginning if study 
procedures. The criteria that were not evaluated prior to study procedures puts the 
participant at risk of harm.
●
A procedure, treatment, or visit specified in the protocol is conducted outside of the 
required time frame and has clinical consequence; poses risk of harm to the subject or 
others; and/or is thought to be impactful to the scientific integrity of the study.
16.  POTENTIAL BENEFITS TO PARTICIPANTS
There is no expected benefit for individuals participating in the OSA study. If a result is 
concerning, the subject will be notified via risk letter and/or study physician will follow-up with 
subject’s physician if deemed medically necessary.
17.  DATA MANAGEMENT AND PARTICIPANT CONFIDENTIALITY
Subject identifiable medical information obtained as a result of this study is considered 
confidential and disclosure to third parties other than the PI and the co-investigators is prohibited. 
All reports and communications relating to subjects in this study will refer to each subject only by 
their study identification number. Data generated as a result of this study are available for 
inspection on request by Food and Drug Administration or other government regulatory agency 
auditors, Sibel business partners specifically HealthCore, Inc. and the Institutional Review Board 
(IRB).
Subject identity will be protected through use of a coded list of identifiers which will be maintained 
separately from the data set. Source documents, questionnaires, and CRFs are kept in a secured 
area (in a locked cabinet in a locked room) and all electronic data is password protected so that 
only authorized personnel can have access. Photographs may be taken of the sensor on the 
suprasternal notch and finger for scientific and publication purposes only. Photographs and videos 
will be labeled only by subject identification number. All photos will be taken by research personnel 
with a research-dedicated phone and will be stored on a password protected server accessed by 
a password protected computer. Only authorized research personnel listed on the IRB protocol 
will have direct access to this data set, although there may be collaborative exchange of de-
identified data with other research institutions for assistance in the analysis of raw data. De-
identified sleep study raw data will be uploaded to a secure cloud-based platform, Sharefile, for 
use by Sibel study personnel.
Data stored and used for future research will be de-identified. Data will not be used for future 
research outside of the scope of this study. 
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17.1 SOURCE DOCUMENTS AND CASE REPORT FORM COMPLETION
The Investigator and local site study personnel will be trained on case report form (CRF) 
completion and data entry into the REDCap system. The investigator is responsible for all entries 
in the CRF for completeness, accuracy and clarity. The investigator or designee should complete 
the CRF as soon as possible after the information is collected. The investigator is responsible to 
endorse all the information recorded in the CRF and will provide formal approval of the final 
submitted data.
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness 
of the data reported. All source documents should be attributable, legible, contemporaneous, 
original, accurate, and complete to ensure accurate interpretation of data. Clinical site monitoring 
is conducted to ensure that the rights and well-being of human subjects are protected, that the 
reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in 
compliance with the currently approved protocol, ICH Good Clinical Practice (GCP), and 
applicable local regulatory requirement(s).
17.2 CONSENT PROCESS (ALL PARTICIPANTS)
To protect participant confidentiality, we will conduct all research-related discussions and 
informed consent procedures in a private room. If a private room is not available, a designated 
area far enough away from other patients such that they cannot hear the conversation will be 
used. We will obtain written informed consent from the participant in English, using the IRB-
approved consent form, prior to conducting any study procedure. 
The consent process will be completed either in person or remotely by using an electronic consent 
document and collection of an electronic signature with REDCap or other electronic signature 
service like Adobe. The study coordinator will review the Informed Consent in person, by phone 
or in Zoom during the remote informed consent discussion. 
The study procedures, risks, and benefits will be discussed and the study team will answer all 
questions prior to obtaining consent. The person performing the Informed Consent process, will 
ask questions of the study subject to confirm understanding and comprehension of the study. All 
versions of the consent forms will be approved by the relevant ethics committees prior to study 
initiation. 
Eligible participants who do not wish to participate in this study will continue to receive care 
according to local clinical standards.  
17.3 PARTICIPANT CONFIDENTIALITY
Study sites must keep original source documents in secured locations with access limited to 
approved study personnel or team members. Electronic documents will be stored in secure, 
encrypted servers maintained by the study site. 
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17.4 ADDITIONAL PRIVACY NOTE
This study is funded by Sibel Health. Sibel Health has a research collaboration with Anthem and 
its subsidiary companies, a U.S. based health insurer. This additional data privacy notice contains 
information on the transfer of de-identified health information to and use by Sibel Health and 
Anthem Health for internal research purposes or regulatory filings for FDA clearance.
17.5 PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
The following PHI will be collected, and is also listed on the consent form for study enrollment:
●
All information in a medical record 
●
Results of physical examinations
●
Medical history
●
Patient demographics
●
Patient address, phone number and email address
Entry of any data into a study site clinical record during the duration of the research study is also 
PHI that may be collected and listed in the consent form. PHI from the above categories may be 
obtained from the respective study sites and affiliated entities listed as study locations.  
Any research information shared with outside entities during the study will not contain the name, 
address, telephone or social security number or any other personal identifier unless disclosure of 
the identifier is necessary for review by such parties or is required by law or study site policy 
except that such information may be viewed by the Study sponsor and its partners or contractors 
at the Principal Investigator’s office.
18.  MULTI-SITE RESEARCH
Study participants from external (non-Northwestern affiliated sites) may recruit potential study 
subjects by in person solicitation at the approved site by approved research personnel or 
investigators on the study. Study investigators may review their active patients to see if they 
meet enrollment criteria and invite them to participate in the study in person. 
External study sites may create local recruitment or marketing materials and must have those 
materials reviewed and approved by the IRB prior to use. 
Communication and responsibilities of each site are outlined in document (HRP-830) which is 
shared with each external site investigator. All sites will have the most current version of the 
protocol, consent document, and HIPAA authorization provided to them by the Lead Study 
Team. The Lead Study Team and sponsor of this study are responsible for communicating all 
study up-dates, will provide training, and ensure the completion of study training logs for 
external sites.  
All non-compliance with the study protocol or applicable requirements will be reported in 
accordance with local policy and communicated to the lead study site and sponsor. 
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Data will be stored and de-identified locally at each study site. Data sharing and storage will 
follow local site policy and procedures specified in section 17. Data Management and participant 
confidentiality section in this protocol. Each study team is responsible for their study site data, 
de-identification of data and storage of study data in physically or digitally secure methods 
approved at each site. Local data may be transported within the site by approved research team 
members. 
19.  PROTOCOL DEVIATIONS
Any deviation from this protocol will be reported within 5 business days to the responsible IRB.
20.  NON-ENGLISH SPEAKING PARTICIPANTS
Non-English speaking participants may be enrolled if the study team acquires an official 
translation of the approved informed consent form or performs consent with a translator and 
completes the accompanying short form in the participant’s native language. 
The research team will only enroll non-English speaking participants if a member of the study 
team is a fluent or native speaker of their language and assigned to them specifically. This is to 
ensure that continued support, clear communication and study training is possible for all study 
participants. 
21.  GOOD CLINICAL PRACTICE
The current study will be conducted in compliance with the protocol, International Conference on 
Harmonization Good Clinical Practice (ICH-GCP), and the applicable regulatory requirements. 
Study personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective task(s) in accordance with GCP.
22.  INSTITUTIONAL REVIEW BOARD (IRB)
All relevant documents for this study will be submitted to an appropriate Institutional Review Board 
(IRB) for review. A signed and dated letter documenting IRB approval must be obtained prior to 
entering participants at the site. IRBs must be constituted and their authority delegated through 
the institution's normal process of governance according to applicable regulatory requirements 
for each participating site. Each participating institution must provide for the review and approval 
of this protocol and the associated informed consent documents and relevant participant materials 
by an appropriate IRB. For each participating site, the protocol and associated informed consent 
and relevant participant materials will be submitted for approval to the local IRB, as per site local 
regulatory policies and procedures. The study will not commence at any site until initial approval 
is obtained from the designated IRB and an approval to enroll notification is released to the site.
The investigators must obtain approval from the IRB for all protocol amendments and, when 
warranted, changes to the informed consent document and/or participant materials. Protocol and 
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informed consent form amendments can be made only with the prior approval from the PI. The 
investigator may not implement any protocol deviation except where necessary to eliminate an 
immediate hazard to study participants, or when change(s) involve only logistical or administrative 
aspects of the trial, i.e., change of monitor(s) or telephone number(s) (ICH 4.5.2). The investigator 
shall notify the IRB of deviations from the protocol or serious adverse events occurring at the site.
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23.  REFERENCES
1) Senaratna CV, Perret JL, Lodge CJ, et al. Prevalence of obstructive sleep apnea in the 
general population: a systematic review. Sleep Med Rev 2017;34:70-81. 
2) Peppard, PE, Young T, Palta M, Skatrud J. Prospective study of the association between 
sleep disordered breathing and hypertension. New Eng J Med 2000;342:1378-84. 
3) Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with 
obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway 
pressure: an observational study. Lancet 2005;365(9464):1046-53. 
4) Peppard PE, Szklo-Coxe M, Hla KM, Young T. Longitudinal association of sleep-related 
breathing disorder and depression. Arch Intern Med 2006;66(16):1709-15. 
5) Mulgrew AT, Nasvadi G, Butt A, Cheema R, Fox N, Fleetham JA, Ryan CF, Cooper P, Ayas 
NT. Risk and severity of motor vehicle crashes in patients with obstructive sleep 
apnoea/hypopnoea. Thorax 2008;63(6):536-41. 
6) The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and 
Technical Specifications, Version 2.6. www.aasmnet.org, Darien, Illinois: American Academy of 
Sleep Medicine, 2020
7) Sleep-related breathing disorders in adults: recommendations for syndrome definition and 
measurement techniques in clinical research. The Report of an American Academy of Sleep 
Medicine Task Force, Sleep, 1999, vol. 22 (pg. 667-89)
8) Cleaning and Disinfecting Your Facility. Centers for Disease Control and Prevention. January 
5, 2021. https://www.cdc.gov/coronavirus/2019-ncov/community/disinfecting-building-
facility.html
9) Obuchowski NA et al. Prospective studies of diagnostic test accuracy when disease 
prevalence is low. Biostatistics, Volume 3, No. 4, pages 477-492.
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10) Li J et al. On sample size for sensitivity and specificity in prospective diagnostic accuracy 
studies. Statistics in Medicine, Volume 23, pages 2537-2550.
11) Machin D et al. Sample Size Tables for Clinical Studies, Third Edition. Wiley-Blackwell, 
Chichester, United Kingdom.
12) Zhou XH et al. Statistical Methods in Diagnostic Medicine. Wiley-Interscience, New York.
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APPENDIX A - PHONE RECRUITMENT SCRIPT
Hello, my name is _______________ and I am a part of the research team at <insert site>. We 
are currently working on a research study with your physician and care team who provided us 
with your information or you have reached out to us after seeing our flyers about the study. We 
are currently working on a study which uses a wireless, wearable device to remotely diagnose 
sleep related breathing disorders at home.
Are you interested in speaking with me for a few minutes about this?
No? Okay thank you for your time!
Yes? Continue: Before we begin, I’d like to confirm that you’re 22 years old or older and have 
recently been prescribed a Polysomnography (PSG) test or Home Sleep Test by your doctor.  Are 
you currently pregnant, nursing, or planning to become pregnant in the next 6 months? Also, do 
you have any skin disorders on your chest or hands? Do you have a history of dementia?
No? I’m sorry. It is required that you must fall under these inclusion criteria and exclusion criteria 
in order to participate in this study. Have a nice day! 
Yes? Great. The study entails wearing a small, flexible, wireless device on your chest and a small, 
flexible, wireless device wrapped around your finger. You will wear the device over one night 
during an in lab Polysomnography sleep test coordinated by our team. You will also be asked to 
complete a dairy and a survey on the usability of the sensors. This study pays $150. If you are 
interested, we will schedule approximately 1 hour to discuss the study in greater detail, show you 
the device, and set you up as a study participant.
Does this sound like something you are interested in participating?
No? That’s perfectly okay. Thank you again for your time and if you change your mind, please 
feel free to call back at (your phone number).
Yes? That’s great! 
Recruitment instructions:
Remote: I can share the informed consent document with you electronically and I am available 
to review with you over the phone. Is now an okay time to send that and discuss?
Yes? Great, please confirm that <contact information> is correct and the best place to share 
this with you. 
No? Ok, please let me know the best <contact information> to use for sharing this with you and 
when is a good time to review together. 
If leaving a voicemail message: 
Hello, this is <name> calling from <study site>. I am following up on an email that was sent to 
you about a paid, 1 night sleep study. If you are interested in hearing more about this research 
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volunteer opportunity please contact me at <contact number, email> or reply to the email sent to 
you about this study. Thank you!
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APPENDIX B - EMAIL RECRUITMENT SCRIPT
Subject: Recruiting Volunteers for paid Sleep Study
The following is a letter letting you know about a research volunteer opportunity with 
<insert site name>. If you do not wish to be contacted to learn more about this or other 
research opportunities please reply to this email and state that you do not wish to be 
contacted.
Hello,
I am writing to tell you about a research volunteer opportunity at <insert site name>.  You are 
being contacted because you have been or currently are a patient at <insert site name> or you 
have reached out to us after seeing our flyers about the study. 
Who is this study for?
This study is for adults who may have Obstructive Sleep Apnea (OSA) and a Polysomnography 
Test (PSG) ordered by their doctor.
What is the study about?
The purpose of this study is to test a small wearable sensor that can monitor and evaluate 
people’s health, detect sleep related respiratory problems, and to see how well it can find OSA 
compared to other kinds of tests.
What will you do if you participate?
If you qualify and decide to participate, you will be asked to: 
Complete informed consent where we talk about the study in detail and then review how to use 
the sensors. The sensors are wireless, small, and soft devices that sticks to the skin with an 
adhesive or wraps around the finger. It is worn on overnight.
Participation in this study will involve minimal to no cost to you, and you will be paid for 
participating in this study for 1 day. Your participation is completely voluntary. You can leave the 
study at any time, and it will not be held against you, nor will it have an effect on the medical care 
you receive here at <insert site>.    
What should you do if you are interested in participating?
Please compete go to this survey to see if you are eligible:
●
<insert survey link>
If you would like to learn more about this study, you can contact the research team: 
●
<insert contact information>
A study coordinator will call you in the next week to tell you more about the study and answer 
any questions you may have. If you do not wish to be contacted, please call or email the contacts 
above. 
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Sincerely,
<Insert contact information>
APPENDIX C – PATIENT RECRUITMENT FLYERS
Flyer 1
Flyer 2
 
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Flyer 3 (Facebook or other localized social media)
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APPENDIX D - STOP-BANG QUESTIONNAIRE
Snoring: Do you snore? Loud enough to be heard through closed doors or loud enough 
to disturb your partner?
Yes
No
 Tired: Do you often feel tired, fatigued or sleepy during the daytime?
Yes
No
Observed: Has anyone observed you stop breathing, choking or gasping while you were 
sleeping?
Yes
No
Pressure: Are you being treated for high blood pressure?
Yes
No
Body Mass: What is your Body Mass Index (BMI)?
Height (in inches):
Weight (in pounds):
Less than 25
 
Greater than 25
Greater than 30
 
Greater than 35
 
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Age: Are you older than 50?
Yes
No
Is your shirt collar 16 inches / 40 cm or larger?
Yes
No
Unknown
Gender: Are you male?
Yes
No
OSA - Low Risk: Yes to 0 - 2 questions
OSA - Intermediate Risk: Yes to 3 - 4 questions
OSA - High Risk: Yes to 5 - 8 questions
or Yes to 2 or more of 4 STOP questions + male gender
or Yes to 2 or more of 4 STOP questions + BMI > 35kg/m2
or Yes to 2 or more of 4 STOP questions + neck circumference 17 inches / 43cm in male or 16 
inches / 41cm in female
Eligibility Screening questions:
Are you 22 or older?
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 Do you have significant cardiorespiratory disease including any of the following?
        
Chronic obstructive pulmonary disease (COPD)
        
Congestive Heart Failure
        
Atrial Fibrillation
        
Other (please describe)
Have you previously been hospitalized for cardiorespiratory issues?
-If yes, please describe.
Do you have an implanted pacemaker or defibrillator?
Do you use oxygen while sleeping?
Do you have respiratory muscle weakness due to neuromuscular condition?
Have you experienced awake hypoventilation or suspicion of sleep related hypoventilation 
(breathing at an abnormally slow rate)?
Have you used opioid medication for more than 3 months?
Have you ever had a stroke?
Do you have a history of severe insomnia?
Do you have a history of dementia?
Epworth Sleepiness Scale (ESS)Please rate how likely you are to doze or fall asleep in 
the following situations by selecting the response that best applies. If you have not done 
some of these activities recently, select what would most likely happen if you were in 
that situation.
Scale: 
0: Never doze
1: Slight chance of dozing
2: Moderate chance of dozing
3: High chance of dozing
Activities: 
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Sitting and reading 0 1 2 3
Watching television 0 1 2 3
Sitting inactive in a public place (eg, a theater or a meeting) 0 1 2 3
As a passenger in a car for an hour without a break 0 1 2 3
Lying down to rest in the afternoon when circumstances permit 0 1 2 3
Sitting and talking to someone 0 1 2 3
Sitting quietly after a lunch without alcohol 0 1 2 3
In a car, while stopped for a few minutes in traffic 0 1 2 3
Follow up enrollment questions:
What is the best phone number to reach you at?
What is your preferred email address?
What is the best time to contact you? (Day(s), time(s))
Are you fully vaccinated for Covid-19? 
(2 weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or 
2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine)

Please indicate your preferred participation site (one in-person visit required for this 
study): Northwestern Medicine Center for Circadian and Sleep Medicine (676 N Saint 
Clair St, Chicago, IL 60611)

Northwestern Medicine Central DuPage Hospital Sleep Health Center (25 N. Winfield 
Road, Winfield, IL 60190)

Northwestern Medicine Grayslake Outpatient Center (1475 E. Belvidere Road, 
Grayslake, IL 60030)
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APPENDIX E - SLEEP DIARY
                                
          
           ID/NAME: 
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APPENDIX F – PATIENT SURVEYS
APNEAS ANNE Sleep Sensor Survey
Subject #: _________
 Date: ____/_____/_____
Thank you for participating in wearing the ANNE Sleep system. This survey helps researchers better 
understand your experience with wearing sensors and helps develop and improve them for future patients. 
Please provide one answer to each of the following questions. You can skip any questions you do not 
know the answer to or do not want to answer. 
1. Overall, PSG was comfortable for me to sleep with:
Strongly 
Agree
Agree
Neither 
agree or 
disagree
Disagree
Strongly 
Disagree
2. Overall, ANNE Sleep sensors were comfortable for me to sleep with:
Strongly 
Agree
Agree
Neither 
agree or 
disagree
Disagree
Strongly 
Disagree
3. How quickly you fell asleep comparing to typical nights for you 
Much 
Slower
Slower
About 
the same
Faster
Much 
Faster
4. The ANNE Sleep Sensors would be more comfortable to wired sensors used in a PSG (sleep test) in the 
hospital
Strongly 
Agree
Agree
Neither 
agree or 
disagree
Disagree
Strongly 
Disagree
5. The application of the ANNE Sleep Sensors was easy and comfortable.
Strongly 
Agree
Agree
Neither 
agree or 
disagree
Disagree
Strongly 
Disagree
6. The removal of the ANNE Sleep Sensors was easy and comfortable.
Strongly 
Agree
Agree
Neither 
agree or 
disagree
Disagree
Strongly 
Disagree
7. Using wireless ANNE Sleep Sensors would be easy to do at home. 
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Strongly 
Agree
Agree
Neither 
agree or 
disagree
Disagree
Strongly 
Disagree
8. Please describe how the wireless Chest sensor felt while sleeping.
Very 
uncomfortable
Uncomfortable
No 
change
Comfortable 
Very 
comfortable
9. Please describe how the wireless Limb sensor felt on your finger while sleeping.
Very 
uncomfortable
Uncomfortable
No 
change
Comfortable 
Very 
comfortable
10. Please indicate if you experienced the following while wearing the wireless sensors:
Redness
Irritation
Both
None
11. Having my sleep data collected at home and sent to my doctor would be more convenient for me.
Strongly 
Agree
Agree
Neither 
agree or 
disagree
Disagree
Strongly 
Disagree
12. I could see myself using ANNE Sleep at home to monitor my breathing while I sleep. 
Strongly 
Agree
Agree
Neither 
agree or 
disagree
Disagree
Strongly 
Disagree
13. Please provide any other thoughts about the concerns or benefits of wireless monitoring:  
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APPENDIX G - INFORMED CONSENT FORM (ICF) <See separate document>
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APPENDIX H - STUDY KIT CLEANING INSTRUCTION
Study sensors are reusable after completion of study procedures and data collection. Used study 
kit containers will be wiped on the outside using Sani-Cloth before handling and placed in a fume 
hood labeled “Contaminated Study Kits” in accordance with the study protocol.
The following procedures will be conducted by a research assistant from the study sites:
1.
The researcher assistant is to wear appropriate PPE including lab coat, and nitrile gloves 
before handling any study supplies.
2.
The fume hood labeled “Contaminated Study Kits” will have all surfaces cleaned and 
wiped down with Sani-Cloth and/or 70% EtOH solution. 
3.
The outside of study kit containers will be cleaned and wiped down with Sani-Cloth and/or 
70% ETOH solution.
4.
Once all used study kits are cleaned on the outside they may be opened, one at a time, 
to have contents cleaned. All study sensors, devices, chargers, cords and accessories will 
be wiped with Sani-Cloth and allowed 2 minutes to air dry on a cleaned surface. 
5.
Sensors will be closely examined for physical breaks, holes or tears in the silicone 
packaging. Any sensors that have physical damage will be sealed in separate plastic 
containers or plastic bags and labeled for return to the manufacturer. 
6.
Do not reuse towelette. Dispose of used Sani-Cloth in trash. 
7.
Individually wrapped, sealed adhesives may be cleaned in the same process. 
8.
Unsealed adhesives will be discarded along with any printed materials from the study kit. 
9.
Once all contents of the study kit have been removed from the container, inside of study 
kit containers will be cleaned and wiped down with Sani-Cloth and/or 70% EtOH solution. 
Allow to air dry for 2 minutes.
10. Return study kit contents to the study container. 
11. The fume hood with Contaminated Study Kits will have all surfaces cleaned and wiped 
down with Sani-Cloth and/or 70% EtOH solution. 
12. Cleaned study kits may be placed in the “Clean Kits” designated area for reuse.
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APPENDIX I – DEMOGRAPHIC, MEDICAL HISTORY AND SLEEP SURVEY
Field Label
Choices, Calculations, OR Slider Labels
In order to ensure that this research serves all people living in the U.S., we need to ask you 
how identify your ethnic and racial background. This information will remain confidential, and 
will not affect your participation in the study in any way. It will only be used for reporting 
general demographics or statistics.
The following questions are about your demographic background:
Gender
1, Male | 2, Female
Race:
1, American Indian or Alaska Native | 2, Asian | 3, Native Hawaiian or Pacific 
Islander | 4, Black or African American | 5, White | 6, More than once race | 
7, Choose not to answer
Ethnicity:
1, Hispanic or Latino | 2, Non-Hispanic or Latino | 3, Choose not to answer
Highest 
Education 
Level 
completed:
1, Never attended school or only attended kindergarten | 2, Grades 1 through 
8 (Elementary) | 3, Grades 9 through 11 (Some high school) | 4, Grade 12 or 
GED (High school graduate) | 5, College 1 year to 3 years (Some college or 
technical school) | 6, College 4 years of more (College graduate)
Current 
Marital 
Status:
1, Married | 2, Single | 3, Widowed | 4, Divorced/Seperated | 5, Domestic 
partner
Current 
Employment 
Status:
1, Employed | 2, Unemployed | 3, Retired | 4, Retired due to disability
The following questions are about your Health:
Date of last 
medical 
exam:
Primary Care 
Provider:
Primary Care 
Provider 
Address:
Primary Care 
Provider 
Phone 
Number:
Sleep 
Provider:
Location:
1, Northwestern Memorial Hospital (Downtown) | 2, Carle Hospital | 3, 
Northwestern Lake Forest Hospital | 4, Central DuPage Hospital (CDH) | 5, 
IRB #: STU00213322-MODCR0001 Approved by NU IRB for use on or after 9/13/2021 through 9/12/2022.

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Northwestern Medical Group (NMG)
Height:
Weight:
Are you currently diagnosed or do you have a history of any cardiovascular disorders? 
Please select 
all that apply:
1, Hypertension (high blood pressure) | 2, Congenital heart disease 
(malformations of heart structure existing at birth) | 3, Arrhythmia (abnormal 
heart rhythm) | 4, Coronary artery disease (narrowing of the arteries) | 5, 
Deep vein thrombosis (blood clot in lower extremities) | 6, Pulmonary 
embolism (blood clot in the lungs) | 7, Heart attack | 8, Heart failure | 9, 
Cardiomyopathy (heart muscle disease) | 10, Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any pulmonary or respiratory system 
disorders? 
Please select 
all that apply:
1, Asthma | 2, Chronic Obstructive Pulmonary Disease (COPD) | 3, Chronic 
Bronchitis | 4, Lung Cancer | 5, Pneumonia | 6, Emphysema | 7, COVID-19 | 
8, Plueral Effusion (collection of fluid between the lung and chest wall) | 10, 
Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any gastrointestinal (GI) disorders? 
Please select 
all that apply:
1, Acid reflux | 2, Heartburn | 3, GERD | 4, Crohn's disease | 5, Ulcerative 
colitis | 6, Irritable Bowel Syndrome (IBS) | 7, Peritonitis | 8, Fibrosis adn 
cirrhosis of liver | 9, Cholecystitis | 10, Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any endocrine system disorders? 
Please select 
all that apply:
1, Hyperthrodism | 2, Hypothyroidism | 3, Throtoxicosis | 4, 
Hypoparathyrodism | 5, Type I Diabetes | 6, Type II Diabetes | 7, Adrenal 
disorder | 8, Cushing's syndrome | 10, Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
IRB #: STU00213322-MODCR0001 Approved by NU IRB for use on or after 9/13/2021 through 9/12/2022.

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status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any neurological disorders? 
Please select 
all that apply:
1, Dementia | 2, Huntington's Disease | 3, Parkinson's Disease | 4, 
Alzheimer's Disease | 5, Bell's Palsy | 6, Cerebral Aneurysm | 7, Epilepsy or 
Seizures | 8, Fibromyalgia | 9, Amyotrophic Lateral Sclerosis (ALS) | 10, 
Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any sleep disorders? 
Please select 
all that apply:
1, Insomnia | 2, Restless Leg Syndrome | 3, Parasomnia | 4, Sleep Apnea 
(confirmed diagnosis) | 5, Narcolepsy | 10, Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any psychiatric or psychological 
disorders? 
Please select 
all that apply:
1, Bipolar disorders | 2, Depression | 3, Anxiety | 4, Post-traumatic stress 
disorder (PTSD) | 5, Schizophrenia | 6, Personality disorders | 10, Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any lymphatic or hematologic 
disorders? 
Please select 
all that apply:
1, Lymphedema | 2, Hodgkin's Lymphoma | 3, Non-Hodgkin's Lymphoma | 4, 
Anemia | 5, Sickle cell | 6, Leukemia | 10, Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any skin or dermatological disorders? 
Please select 
all that apply:
1, Acne | 2, Hives | 3, Rosacea | 4, Eczema | 5, Psoriasis | 6, Melanoma | 10, 
Other
If other, 
please 
explain:
IRB #: STU00213322-MODCR0001 Approved by NU IRB for use on or after 9/13/2021 through 9/12/2022.

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If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Are you currently diagnosed or do you have a history of any musculoskeletal disorders? 
Please select 
all that apply:
1, Carpal tunnel | 2, Arthritis | 3, Osteoporosis | 4, Tension Neck Syndrome | 
5, Tendonitis | 6, Broken bone | 7, Tendon or Ligament Sprain | 8, Torn 
Rotator Cuff | 9, Ruptured or Herniated Disc | 10, Other
If other, 
please 
explain:
If you selected any of the above disorders, please include dates of diagnosis and current 
status (ongoing or resolved). If resolved, please include end date:
Do you have a history of any allergies? This can include seasonal, skin, food, or 
drug/medicine allergies.
Please list allergies here, including start dates and current status (ongoing or resolved). If 
resolved, please include end date:
Do you have a history of any other medical illness? 
The following questions are about your sleep last night (before study visit).
Please list all other medical illnesses here, including start dates and current status (ongoing 
or resolved). If resolved, please include end date:
2. Did you wear CPAP Device last night?
If yes, level of 
titration:
3. What time did you go into bed? {time_in_bed} 
4. What time did you try to go to sleep? {time_sleep} {ampm}
1, AM | 2, PM
5. How long did it take you to fall asleep?
6a. How many times did you wake up, not counting your final awakening?
6b. In total, how long did these awakenings last? 
7a. What time was your final awakening? 
7b. After your final awakening, how long did you spend in bed trying to fall back asleep?
7c. Did you wake up earlier than you planned?
7d. If yes, 
how much 
earlier?
8. What time did you get out of bed for the day? {time_up} {am_and_pm}
9. In total, how long did you sleep?
10. How 
would you 
rate the 
quality of your 
sleep?
1, Very poor | 2, Poor | 3, Fair | 4, Good | 5, Very good
IRB #: STU00213322-MODCR0001 Approved by NU IRB for use on or after 9/13/2021 through 9/12/2022.

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Protocol Version 1.1 Date:  08.22.2021
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11. How 
rested or 
refreshed did 
you feel when 
you woke up 
for the day?
1, Not at all rested | 2, Slightly rested | 3, Somewhat rested | 4, Well-rested | 
5, Very well-rested
12a. How many times did you nap or doze?
12b. In total, how long did you nap or doze?
13a. How many drinks containing alcohol did you have?
13b. What time was your last drink? {time_drink}{am_pm_2}
14a. How many caffeinated drinks (coffee, tea, soda, energy drinks) did you have?
14b. What time was your last drink? {time_coffee}{am_pm_3}
15. Did you take any over-the-counter or prescription medication(s) to help you sleep?
Type of 
medication:
Dose:
Time taken:
Did you take any additional medications?
Type of 
medication:
Dose:
Time taken:
16. 
Comments, if 
applicable:
IRB #: STU00213322-MODCR0001 Approved by NU IRB for use on or after 9/13/2021 through 9/12/2022.