Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children
Phase: NA
Conditions: Hospitalization
Sponsor: Intermountain Health Care, Inc.

 
1 
 
PROTOCOL SUMMARY 
Title 
 
Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized 
Children 
Protocol ID # 
1052853 
Protocol Issue Date 
March 25, 2024 
IRB Approval Date 
 
June 27, 2024 
Amendment Date(s) 
November 15, 2024; February 13, 2025 
Location of 
Research 
Primary Children’s Hospital, 100 Mario Capecchi Dr., Salt Lake City, 
UT 
 
Principal 
Investigator 
Leandra Bitterfeld, RN, MSN, PhD(c), Research Nurse Coordinator, 
Primary Children’s Hospital 
 
Co-Principal 
Investigator, if 
applicable 
Not applicable 
 
Sub-Investigators 
 
Brianna Peterson Waldron, RN, BSN 
Julianne Mathias, RN, BSN, CPN 
 
Internal 
Collaborators 
 
Jody Osteyee, DNP, APRN, CPNP-PC, EBP-C 
Scott Short, MD 
Frank Cipriano, MD 
 
External 
Collaborators 
 
Not applicable 
 
Sponsor 
Intermountain Foundation at Primary Children’s Hospital 
 
Contract Research 
Organization (CRO) 
(if applicable) 
Not applicable 
 
Study Team 
 
PROTOCOL 
SUMMARY 
 
Purpose of Study 
 
To understand the effect of forgone overnight vital signs on sleep 
quality and duration among children hospitalized in medical-surgical 
units, compared with children who receive standard of care vital 
signs. 
Design 
 
Non-randomized controlled study 
 
Study Duration 
March 2024-March 2025 
 
Number of Subjects 
 
160 
 

 
2 
Description of 
Subject Population 
Patients hospitalized on a pediatric medical-surgical floor who are 
eligible for reduced overnight vital signs monitoring, as described 
below.  
 
Eligibility Criteria 
Inclusion criteria:  
- 
Hospitalized at Primary Children's Hospital on units 3SE, 3NE, 
3NW 
- 
Age 1-18 years 
- 
PEWS score ≤ 1 at 2000  
- 
A parent/home caregiver present to consent to study 
- 
Patient and home caregiver speak English or Spanish. 
- 
Deemed appropriate for forgone overnight vital signs by care 
team (attending MD/Advanced Practice Provider and bedside 
RN).    
Exclusion Criteria 
- 
Pre-existing diagnosis of hypertension, kidney disease, 
pulmonary hypertension, chronic lung disease, congenital 
heart disease causing cardiopulmonary compromise, 
obstructive sleep apnea, seizure disorder, neuromuscular 
disability.  
- 
Patients requiring O2 monitoring at home.  
- 
The following medications in the previous 24 hours: opioids, 
intravenous immunoglobulin, intravenous magnesium, 
continuous albuterol, benzodiazapines, other sedating 
medications beyond home regimen.  
- 
Anaphylaxis within 24 hours 
- 
Within the first 24 hours post-operative period 
- 
Requiring oxygen above baseline 
- 
Fever in the last 24 hours.  
- 
Sepsis alert in the last 72 hours.   
 
Screening and/or 
Recruitment 
Location 
 Medical-surgical units (3SE, 3NE, 3NW) at Primary Children’s 
Hospital 
 
Brief Description of 
Study Procedures 
 
Patients will be screened at Primary Children’s Hospital. Patients who 
are deemed eligible to forgo overnight vital signs will be considered 
for study.  After written informed consent (parental permission/assent) 
is obtained, subjects who meet eligibility criteria will be allocated 1:1 
to 2 treatment arms in sequential order: Group 1: standard of care 
vital signs monitoring and Group 2: no overnight vital signs at 0000 
and 0400.  The study period is approximately 24 hours, including one 
night of sleep. All participants will wear an actigraphy watch for one 
night and complete a sleep diary and sleep disruption survey after the 
study night.  
 
Primary Endpoint 
 
The primary endpoint is total sleep time, as measured by actigraphy.  
 
Secondary 
Endpoints 
 
- 
Nocturnal wake frequency, nocturnal wake duration 
(actigraphy) 
- 
Self-reported total sleep time (sleep diary) 

 
3 
- 
Self-reported overnight disruptions (sleep diary) 
- 
Self-reported restfulness upon waking (sleep diary) 
- 
Self-reported sleep disturbances (sleep disturbance survey) 
 
Analysis 
Population(s) 
Intent-to-treat 
Benefits 
The direct benefit to the research participants is that they may 
experience improved sleep related to forgoing overnight vital signs 
monitoring. Furthermore, the information gleaned from this study may 
inform policies and practices that inform sleep for hospitalized 
children in the future.  
Risks 
 
This study presents no more than minimal risk. Risks associated with 
wearing the actigraphy watch include potential minor discomfort. The 
risk associated with forgoing vital signs administration is an unnoticed 
decline in clinical status. This risk will be mitigated by q. 4 hour PEWS 
score monitoring by the bedside nurse. This risk will be further 
mitigated by allowing for as needed vital signs administration if 
anyone in the clinical team is concerned about the participant’s 
clinical status.  
Authors 
N/A 
 
Disclaimer: 
The information in this document is confidential and will not be disclosed to others without 
written authorization from Intermountain Healthcare. 

 
4 
TABLE OF CONTENTS 
 
1.0 
INTRODUCTION .............................................................................................................................. 8 
1.1 
Background and Rationale ...................................................................................................... 8 
1.2 
Previous Work ........................................................................................................................... 8 
2.0 
STUDY OBJECTIVES/PURPOSE OF THE STUDY .................................................................. 8 
2.1 
Hypothesis/Research Questions ............................................................................................ 8 
3.0 
STUDY DESIGN ............................................................................................................................... 9 
3.1 
Study Duration ........................................................................................................................... 9 
3.2 
Number of Subjects .................................................................................................................. 9 
3.3 
Screening and Selection of Subjects ..................................................................................... 9 
3.3.1 
Inclusion Criteria ................................................................................................................... 9 
3.3.2 
Exclusion Criteria .................................................................................................................. 9 
4.0 
STUDY PROCEDURES ................................................................................................................ 10 
4.1 
Informed Consent ................................................................................................................... 10 
4.2 
Methods .................................................................................................................................... 11 
4.3 
Study Treatments .................................................................................................................... 11 
4.4 
Study Visits/Study Evaluations ............................................................................................. 12 
4.5 
Clinical Tests and Procedures .............................................................................................. 12 
4.5.1 
Pre-Intervention Tests and Procedures .......................................................................... 13 
4.5.2 
Intra-Intervention Tests and Procedures ........................................................................ 13 
4.5.3 
Post-Intervention Tests and Procedures ........................................................................ 13 
4.5.4 
Follow-Up Evaluations ....................................................................................................... 14 
4.6 
Risks ......................................................................................................................................... 14 
4.7 
Benefits ..................................................................................................................................... 14 
5.0 
CONCOMITANT MEDICAL THERAPY ...................................................................................... 14 
5.1 
Pre-Intervention Medications ................................................... Error! Bookmark not defined. 
5.2 
Peri-Intervention Medications .................................................. Error! Bookmark not defined. 
5.3 
Post-Intervention Medications.................................................. Error! Bookmark not defined. 
6.0 
MONITORING AND SAFETY REPORTING .............................................................................. 14 
6.1 
Monitoring ................................................................................................................................ 14 
6.2 
Safety Reporting ..................................................................................................................... 14 

 
5 
7.0 
END OF STUDY CONSIDERATIONS ........................................................................................ 15 
7.1 
Study Completion .................................................................................................................... 15 
7.2 
Voluntary Withdrawal of Consent ......................................................................................... 15 
7.3 
Early Termination .................................................................................................................... 15 
7.4 
Lost to Follow-Up Subjects .................................................................................................... 16 
7.5 
Disposition of Investigational Product .................................................................................. 16 
7.6 
Records Retention .................................................................................................................. 16 
8.0 
DATA MANAGEMENT AND STATISTICAL ANALYSIS .......................................................... 16 
8.1 
Data Collection ........................................................................................................................ 17 
8.2 
Sample Size Calculation ........................................................................................................ 17 
8.3 
Evaluation Endpoints .............................................................................................................. 18 
8.3.1 
Primary Endpoint ................................................................................................................ 18 
8.3.2 
Secondary Endpoints ......................................................................................................... 18 
8.3.3 
Tertiary Endpoints ................................................................. Error! Bookmark not defined. 
8.4 
Statistical Analysis .................................................................................................................. 18 
8.4.1 
Populations for Analysis .................................................................................................... 18 
8.4.2 
Statistical Methods ............................................................................................................. 18 
9.0 
DISSEMINATION OF RESULTS ................................................................................................. 18 
9.1 
Release of Information to Participants ................................................................................. 18 
9.2 
Public Release of Information ............................................................................................... 19 
9.3 
Data-Sharing with Collaborators ........................................................................................... 19 
9.4 
Publications .............................................................................................................................. 19 
10.0 FINANCIAL CONSIDERATIONS ................................................................................................. 19 
10.1 
Funding Source ....................................................................................................................... 19 
10.2 
Compensation ......................................................................................................................... 20 
10.3 
Disclosure of Conflicts of Information .................................................................................. 20 
11.0 REFERENCES ............................................................................................................................... 21 
12.0 APPENDICES ................................................................................................................................. 23 
Appendix A:  Study Tools and Investigational Product Information ................................................. 24 
Appendix B:   Safety-Related Events .................................................................................................... 32 
Appendix C:   Other Oversight ............................................................................................................... 33 
Appendix D:   Declaration of Helsinki .................................................................................................... 34 

 
6 
13.0 PROTOCOL SIGNATURE PAGE ................................................................................................ 40 
 
 
 
 

 
7 
DEFINITIONS 
 
• 
Q4: every 4 hours 
• 
Q12: Every 12 hours 
• 
Q4 vital signs: measurement of blood pressure (BP), heart rate (HR), respiratory rate 
(RR), oxygen saturation level (SpO2), and temperature.  
• 
Routine vital signs: measurement of blood pressure q12 hours and measurement of HR, 
RR, SpO2 and temperature every 4 hours.  
• 
Standard of care vital signs: Q4 or routine vital signs as ordered by the care team prior 
to study enrollment.  
• 
PEWS: Pediatric Early Warning Sign  
 
 

 
8 
1.0     INTRODUCTION 
 
1.1 
Background and Rationale 
 
Adequate sleep is vital for healing and optimal functioning, and sleep deprivation negatively 
impacts the body’s breathing, circulation, immune system function, endocrine function, and 
metabolism (American Academy of Nursing [AAN], 2015). A lack of sleep is also associated with 
diminished cognitive and emotional functioning (Vriend et al., 2015), an increase in self-reported 
pain, altered pain threshold (Schrimpf et al., 2015), and depressive symptoms (Hillman, 2021). 
Hospitalized children are at high risk for disturbed sleep and its physiological effects given the 
high-sensory and unfamiliar nature of hospitals.   
 
Overnight vital signs are typically done every four hours on pediatric acute care units, despite 
limited evidence supporting the efficacy of this practice (Mann, 2019). Additionally, vital signs 
are often ordered and collected without considering the patient’s clinical status or the potential 
impact that they may have on sleep. This practice is in direct contradiction to guidance from the 
American Academy of Nursing’s Choosing Wisely Campaign that states: “Don’t wake the patient 
for routine care unless the patient’s condition or care specifically requires it” (AAN, 2015).   
 
This team’s previously published scoping review (Bitterfeld et al., 2023) found that vital sign 
checks and nursing cares are the most frequent cause of nighttime awakenings among 
hospitalized children (Crawford et al., 2019; Herbert et al., 2014; Meltzer et al., 2012; Stremler 
et al., 2021).Additionally, only one study included sleep duration as an outcome of reducing vital 
signs. They found that sleep duration increased by 82.4 minutes for children older than 24 
months (p < 0.001) when forgoing nonessential blood pressures overnight, and there was no 
significant difference in sleep duration among children less than 24 months old (Cook et al., 
2020). Three quality improvement projects (Cook et al., 2020; Lee et al., 2021; Lin et al., 2022) 
experienced no escalations of care (PICU transfer or rapid response team calls) or code blue 
events among children where overnight vital signs were reduced.  
 
1.2 
Previous Work 
 
The PI and sub-Is of this study recently published a scoping review of the effect of reduced 
overnight vital signs on sleep among hospitalized children. The PI is a nurse and PhD candidate 
with extensive research experience. The sub-Is are both nurses who completed the 
Intermountain Evidence-based Practice (EBP) course and are involved in additional research 
and quality improvement (QI) projects.  
 
2.0     STUDY OBJECTIVES/PURPOSE OF THE STUDY 
 
Understand the effect of forgone overnight vital signs on sleep quality and duration among 
children hospitalized in medical-surgical units, compared with children who receive standard of 
care vital signs.  
 
2.1 
Hypothesis/Research Questions 
 
Children who do not have vital signs taken overnight, defined as no vital signs measured at 
0000 and 0400, will experience significantly greater sleep quality and longer periods of 
uninterrupted sleep, when compared with children who experience standard of care vital signs 
monitoring, defined as vital signs taken every 4 hours.  

 
9 
 
3.0 STUDY DESIGN 
 
This is a non-randomized controlled study to evaluate the effect of forgoing overnight vital signs 
on sleep quality and duration. Patients will be screened at a single center. Subjects will be 
sequentially recruited, first into the control cohort, and then into the experimental cohort.  
 
3.1 Study Duration 
 
The study will last for approximately 12 months (a target of up to 8 months to recruit the 
required subjects and 4 months for study closure and analysis). The approximate target start 
and stop dates for the study are March 2024 and March 2025, respectively. 
 
2.2 
Number of Subjects 
Approximately 160 patients will be enrolled/consented into the study (1:1 ratio; see section 4.3 
for details). 
The expected drop-out rate for this study is 20%. Hence, it is expected that 160 patients will be 
enrolled to meet the target of 128 subjects who will complete the trial (see section 8.2 for 
sample size calculation).  
 
2.3 
Screening and Selection of Subjects 
Patients hospitalized on a medical-surgical unit at Primary Children’s Hospital will be screened 
for this study.  The Principal Investigator, Sub-Investigator and/or the designated Clinical 
Research Coordinator will review the patient’s history and medical records and discuss eligibility 
with the attending medical provider or Advanced Practice Provider.  Data gathered is used to 
evaluate the patient in relation to the inclusion and exclusion criteria listed below.  It may be 
necessary to exclude subjects based on this assessment.     
 
A patient-screening log will be maintained throughout the study.  The log will record all subjects 
considered for enrollment in the trial and indicate whether they were enrolled or not enrolled.  In 
the case of non-enrollment, an explanation will be provided on the log as to the reason for their 
exclusion. 
 
2.3.1 Inclusion Criteria  
Iris section 5.1 
Inclusion criteria:  
- 
Hospitalized at Primary Children's Hospital on units 3SE, 3NE, 3NW 
- 
Age 1-18 years 
- 
PEWS score ≤ 1 at 2000  
- 
A parent/legal guardian present and willing to consent to study 
- 
Patient and home caregiver speak English or Spanish. 
- 
Deemed appropriate for forgone overnight vital signs by daytime care team (attending 
MD and bedside RN).    
Exclusion Criteria 
Iris section 5.1 
- 
Pre-existing diagnosis of hypertension, kidney disease, pulmonary hypertension, chronic 
lung disease, congenital heart disease causing cardiopulmonary compromise, 
obstructive sleep apnea, seizure disorder, neuromuscular disability, unless explicitly 
approved and acknowledged by attending physician_.  
- 
Patients requiring O2 monitoring (pulse oximetry) at home.  

 
10 
- 
The following medications in the previous 24 hours: intravenous immunoglobulin, 
intravenous magnesium, continuous albuterol,  
- 
The following medications in the previous 12 hours: opioids, benzodiazapines, other 
sedating medications beyond home regimen. Children on clonidine alone need not be 
excluded.  
 
- 
Anaphylaxis within 24 hours 
- 
Within the first 24 hours post-operative period 
- 
Requiring oxygen above baseline 
- 
Fever in the last 24 hours.  
- 
Sepsis alert in the last 72 hours.   
 
 
3.0 STUDY PROCEDURES 
 
This study will be conducted in accordance with the ICH Good Clinical Practice guidelines (E6), 
the Code of Federal Regulations (CFR), and the Declaration of Helsinki (see Appendix D).  
Study-specific procedures and tests are described in the sections below. 
 
3.1 
Informed Consent 
Iris section 8.0 
Patients and children that meet eligibility criteria and agree to participate will be considered for 
the study.  Written informed consent using a form that is approved by the Intermountain 
Healthcare Institutional Review Board (IRB) will be obtained prior to study inclusion, signed by 
the subject or his/her legally authorized representative, in accordance with applicable 
regulations.  The LAR can be a family member, health care agent or legal guardian as defined 
by the State of Utah.  
 
Parental permission will be required of all subjects who are under 18 years of age.  In addition 
to parental permission, subjects who are between 7 and 17 years of age will be asked to 
provide assent, and an IRB-approved assent document will be used to document the subject’s 
agreement to participate in this study. In determining whether subjects are capable of assenting, 
the consenter shall take into account the age, maturity and psychological state of the participant 
involved. Assent will be obtained from all children that are deemed capable of providing assent 
by the investigator. If the potentially eligible participant is deemed incapable of providing assent 
due to a cognitive impairment, the research may proceed with permission of the parent(s) alone. 
If the participant gains capacity to provide assent during the course of the study, they will be 
reapproached to obtain assent.  The Principal Investigator or an appropriately delegated 
member of the study team under his/her supervision, will administer the parental permission and 
assent process.   
 
If these subjects turn 18 years old while participating in this study, they will be asked to re-
confirm their agreement to continue their participation by signing a new informed consent form. 
If the participant is unable to give consent, surrogate consent will be obtained from the 
participant’s legally authorized representative, in accordance with applicable regulations.  This 
authorized representative can be a family member, health care agent or legal guardian, as 
defined by the State of Utah. A prospective enrollee’s capacity to provide informed consent for 
research participation will be determined by the Principal Investigator and/or his/her delegate, in 
collaboration with the participant’s inpatient attending physician.  

 
11 
 
The informed consent process will be conducted at an Intermountain Healthcare facility.  The 
Principal Investigator or an appropriately delegated member of the study team (e.g. the Clinical 
Research Coordinator) under his/her supervision, will administer the informed consent process.   
 
Following assessment of qualification for study participation as per inclusion/exclusion criteria, 
eligible patients will be presented with protocol information and will be invited to participate in 
this project. Patients and parents will be provided as much time as they need to consider 
participation, ask questions, and obtain satisfactory answers to their questions.  Patients and 
parents will be asked to provide written consent by signing the informed consent document.  
Unless otherwise indicated, consent will be obtained only after the Principal Investigator and/or 
his/her delegate has/have reviewed and approved the inclusion and exclusion criteria.   
 
3.2 
Methods 
 
Patients will be screened for eligibility per inclusion and exclusion criteria (See Sections 3.3.1 
and 3.3.2 respectively) and consented as described in Section 4.1. 
 
The following information (history) will be obtained from each subject at study onset: 
• 
Age, gender, height, weight 
• 
Location of hospitalization (unit) 
• 
Medical history 
• 
Admitting diagnosis 
 
The following tests/interventions will be conducted: 
• 
Sleep duration recording via actigraphy watch.  
• 
Daily sleep diary completion. 
• 
Sleep disturbance survey completion.  
 
3.3 
Study Treatments 
 
After verifying study eligibility and a written informed consent has been obtained, subjects will 
receive either standard of care vital signs monitoring or forgone overnight vital signs monitoring 
in a 1:1 ratio, as indicated in the Treatment Arm/Intervention Table below. Patients will be 
allocated to these groups sequentially, meaning the first 64 enrolled children will receive 
standard of care vital signs monitoring and the next 64 children will receive no overnight vital 
signs monitoring.   
 
 
Treatment/Intervention 
Arm 
 
Intervention 
Intervention 
Children in the intervention group will not have vital signs taken 
at 0000 and 0400. Bedside nurses will be asked to monitor a 
PEWS score every four hours to assess patient’s clinical status 
and ensure safety. If a patient has a change in clinical status at 
any point during the study period, such that PEWS>1, or if a 
nurse/provider has a concern about a patient’s clinical status, 
vital signs may be taken as the nurse/provider feel is most 
appropriate.  

 
12 
Control 
Standard of care vital signs and PEWS monitoring (ie – no 
change from current orders). This monitoring may include 
routine vital signs or Q4 vital signs 
 
 
3.4 
Study Visits/Study Evaluations 
 
The study period will be one approximately 24-hour period. The study period will be mid-day on 
day 0 to mid-day on day 1. See time and event schedule below.  
 
After obtaining informed consent, subjects will be fitted with an actigraphy watch and instructed 
on survey completion. This visit must be conducted prior to the child’s bedtime (Day 0). After 
fitting the actigraphy watch, subjects will wear the watch for the entire duration of the study 
period, which will be ~24 hours. At the completion of the study period (Day 1), Children 
/caregivers will complete a sleep diary and the PROMIS 8-item Pediatric Sleep Disturbance 
short form. 
 
Time and Events Schedule 
 
Day 0 
Night 1 
Day 1 
Night 2 
Day 2 
Informed consent signed 
X 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
History 
X 
 
 
 
 
Actigraphy 
X 
X 
X 
 
 
Sleep Diary 
 
 
X 
 
 
Sleep Disruption Survey 
(age≥5) 
 
 
X  
 
 
Discontinue actigraphy 
 
 
X  
 
 
Safety events 
X 
X 
X 
X 
X 
 
 
3.5 
Clinical Tests and Procedures 
  
A description of the clinical tools and surveys are outlined below: 
 
Appendix 
Tool 
Concept 
Measured 
Brief 
Description 
Reliability and 
validity 
Score Range 
Completion 
instructions 
A-1 
PEWS score 
Clinical 
status 
Reproducible 
assessment 
of clinical 
status 
Associated with 
lower risk of 
mortality and 
unplanned code 
events (Chong et 
al., 2022).  
0-11, lower is 
greater 
clinical 
stability 
Bedside 
nurse q. 4 hrs 

 
13 
A-2 
Basic Mini 
Motionlogger 
actigraph 
watch 
Total sleep 
time, 
nocturnal 
wake 
frequency, 
nocturnal 
wake 
duration 
according to 
Meltzer, 
Montgomery-
Downs et al. 
(2012)  
An actigraphy 
watch that 
has been 
validated in 
children as 
young as 
three years 
old.  
Sensitivity=0.89 and 
specificity=0.73 
when compared to 
polysomnography. 
Underestimated 
sleep efficacy by 
~4.4%. (Meltzer, 
Walsh et al., 2012).  
N/A 
Apply watch 
prior to 2000 
on day 0. 
Wear 
continuously 
until after 
awakening on 
day 1.  
 
 
A-3 
Sleep Diary 
Self-reported 
sleep 
duration and 
interruptions 
A sleep diary 
modified from 
the National 
Sleep 
Foundation 
(Carney et al., 
2012) to 
accommodate 
study period 
and only 
capture 
information of 
interest.  
The sleep diary was 
developed in 
collaboration with 
insomnia experts 
and potential users. 
Our modifications 
are similar to those 
made by the 
Children’s Hospital 
of Orange County 
sleep diary.  
NA 
Complete by 
children≥8 yo, 
parents for 
children <8 
years old 
(Mazza et al., 
2020). 
 
 
A-4 
PROMIS 8-
item 
Pediatric 
Sleep 
Disturbance 
short form 
Sleep 
disturbances/ 
sleep quality 
A validated 
measure of 
self-reported 
sleep 
disturbances.  
Cronbach’s α=0.91, 
adequate structural 
validity. Concurrent 
validity with general 
health, chronic 
health conditions, 
use of other 
medications for 
sleep (Forrest et al., 
2018). Also 
validated in children 
with 
neurodevelopmental 
disorders (Meltzer 
et al., 2020).  
8-40, higher 
scores 
indicating 
worse sleep/ 
fewer 
disturbances. 
Scores can 
be convered 
to T scores 
Complete by 
children≥8 yo, 
parents for 
children <8 
years old 
 
See Time and Events Schedule table above for specific tests and procedures to be obtained at 
each visit, as follows: 
• 
 
3.5.1 Pre-Intervention Tests and Procedures 
 
None 
 
3.5.2 Intra-Intervention Tests and Procedures 
 
During the study period the following tests and procedures will be done: 
• 
Actigraphy watch sleep monitoring 
• 
Sleep diary 
• 
PROMIS 8-item Pediatric Sleep Disturbance short form survey 
 
3.5.3 Post-Intervention Tests and Procedures 
 

 
14 
Immediately after completion of the study period, no further tests and procedures will be done. 
The clinical status of the patient will be monitored for 24 hours after study completion to monitor 
for any potential safety events, as described in section 5.1.  
 
3.5.4 Follow-Up Evaluations 
 
There are no follow-up evaluations.  
 
3.6 
Risks 
Iris section 7.8 
This study presents no more than minimal risk. Risks associated with wearing the actigraphy 
watch include potential minor discomfort. The risk associated with forgoing vital signs 
administration is an unnoticed decline in clinical status. This risk will be mitigated by q. 4 hour 
PEWS score monitoring by the bedside nurse. The PEWS score is used to identify patients at 
risk for clinical deterioration and has been validated as a predictor of ICU transfer (Agulnik, et 
al., 2017). PEWS scores are routinely documented once per shift and Intermountain policies 
indicate that a PEWS score of 0-2 indicates no additional assessment or intervention is needed. 
This risk will be further mitigated by allowing for as needed vital signs administration if anyone in 
the clinical team is concerned about the participant’s clinical status.  
 
3.7 
Benefits 
Iris section 7.10 
The direct benefit to the research participants is that they may experience improved sleep 
related to forgoing overnight vital signs monitoring. Furthermore, the information gleaned from 
this study may inform policies and practices that improve sleep for hospitalized children in the 
future.  
 
4.0 CONCOMITANT MEDICAL THERAPY 
 
N/A 
     
5.0 MONITORING AND SAFETY REPORTING 
 
5.1 
Monitoring 
Iris section 7.12 
Safety Events 
Safety events of concern include any unnoticed, clinically significant change in clinical status, 
measured as an unplanned transfer to the PICU/CICU, rapid response activation, code sepsis 
alert, or code blue event.  
Safety Monitoring and Reporting 
All safety-related data for this study will be collected on standardized Case Report Forms. The 
PI will be notified of any safety-related events within 12 hours of the occurrence. If a safety 
event occurs, enrollment will be paused while the PI and consulting physicians debrief the event 
and identify underlying causes. Appropriate changes will be made to the protocol if needed. 
Enrollment will resume once any necessary changes are made and amendments approved by 
the IRB.  
 

 
15 
6.0    END OF STUDY CONSIDERATIONS  
 
6.1 
Study Completion 
 
A participating subject will be considered as having completed the study if the subject has met 
the following: 
• 
Completed the treatment/intervention course described in this protocol. 
• 
Has complied with all the procedures as required by the study.  
 
6.2 
Voluntary Withdrawal of Consent 
 
Subjects shall have the ability to withdraw consent for study participation and/or the use of their 
clinical information at any time, without penalty or loss of benefit to which the subject is 
otherwise entitled, by contacting the Principal Investigator or a designated member of his 
research team, preferably in writing and addressed to the Principal Investigator at the address 
indicated on the cover page of this protocol. 
 
In the case a subject enrolled in this study decides to withdraw from the research, or an 
Investigator decides to terminate a subject’s participation, study investigators must follow 
accepted standard practices regarding the management of collected data about these subjects, 
as follows:  
• 
Investigators must document in the research record each instance of a subject’s withdrawal, 
including the reasons for the withdrawal, if known. 
• 
Previously collected information that has been gathered, and all material from the subject's 
identifiable samples that they have at the time of the subject's withdrawal from the study will 
remain in the study to maintain the integrity of the research, in accordance with current FDA 
regulations. 
• 
The investigator(s) may ask the subject whether he/she will agree to continued follow-up 
and further collection of clinical information following his/her withdrawal.   
• 
If the subject withdraws and does not consent to continued follow-up and collection of 
clinical information, the investigator(s) will discontinue access to the subject’s medical record 
or other confidential records, for purposes related to the study. 
• 
Following the subject’s withdrawal from the study, the Study Team will no longer contact the 
subject nor have access to his/her medical records for research purposes (unless specific 
informed consent has been obtained as described above). 
 
In the event of study withdrawal is a participant receiving the forgone vital signs intervention, the 
subject will receive standard of care vital signs monitoring  
 
6.3 
Early Termination 
 
The study sponsor or Principal Investigator of the study may decide to suspend or terminate a 
study for various reasons, including but not limited to the occurrence of an unanticipated 
problem, evidence of noncompliance or serious and/or continuing noncompliance.  If this 
occurs, the Principal Investigator will notify the IRB in writing within three days of the 
suspension/termination.  This communication will include a description of what steps have or will 
be taken to protect the welfare of currently enrolled participants, and what corrective actions, if 
applicable, will be taken to address the root cause for the suspension/termination.  
 

 
16 
The IRB has the authority to suspend the approval of research when it is suspected or 
determined that the following has/have occurred: an unanticipated problem associated with 
unexpected serious harm to research participants, the research is not being conducted in 
accordance with the IRB requirements with possible risk of harm to research participants, and/or 
serious or continuing noncompliance has taken place.   
 
After a suspension of an IRB approval, the IRB has the authority to terminate the research if the 
event(s) prompting the suspension of research approval cannot be corrected in a way that 
serves the best interests of the research participants.  The IRB may also terminate a research 
study if the noncompliance with the IRB requirements is serious and/or continuing and the 
proposed corrective action plan is not sufficient to alleviate or rectify the noncompliance. The 
termination of research involves all research activities (enrollment, treatment and/or 
intervention, follow-up, and data analysis). 
 
6.4 
Lost to Follow-Up Subjects 
 
Because this is a single encounter study, with no periods of time between research-related 
interactions, retention of participating subjects until study completion will not be a challenge. 
There will be no need to recontact subjects.  
 
6.5 
Disposition of Investigational Product  
 
N/A 
 
6.6 
Records Retention  
 
The Principal Investigator and his/her designated research staff are responsible for maintaining 
accurate, complete, and current records relating to the conduct of the investigation, in 
accordance with ICH Good Clinical Practice guidelines (E6) and the Code of Federal 
Regulations (CFR) (refer to ICH GCP 8.1 to 8.4 for a list of essential documents for retention).   
 
In addition, the Principal Investigator and his/her designated research staff are responsible for 
retaining any additional documents as required by Intermountain Health, in accordance with 
departmental and/or institutional records retention policy. 
 
If there is inadequate records storage space at any Intermountain facility, all or part of the 
clinical study records can be sent to an Intermountain-approved archival storage facility that has 
a current executed service contract with Intermountain.  As appropriate, the study sponsor and 
other stakeholders will be notified. 
 
If the Principal Investigator transfers custody of all or part of the clinical study records to another 
person or entity, the IRB must be notified within 10 working days after the transfer occurs.  In 
addition, and as appropriate, the study sponsor and other stakeholders will be notified. 
 
 
7.0 DATA MANAGEMENT AND STATISTICAL ANALYSIS 
 

 
17 
7.1 
Data Collection  
Iris section 11.0 
All required data for this study will be collected on standardized Case Report Forms (CRFs) in 
RedCap, to be created by the Principal Investigator, Clinical Research Coordinator (CRC) or a 
designated member of the study team.  A duly-assigned CRC will perform primary data 
collection drawn from review of source-documents (hospital charts) and from on-going study 
procedures.  
Data will be gathered in several ways.  
 
EHR Data elements: data from the electronic health record will be collected on Day 0-1 and 
entered into RedCap by a CRC. The elements collected and their definition are described 
below.  
 
Element 
Day 
collected 
Definition/Notes 
Age 
0 
Years, gathered from DOB 
Sex 
0 
Male/Female 
Race 
0 
As listed in EHR 
Ethnicity 
0 
As listed in EHR 
Height 
0 
At admission, cm 
Weight 
0 
At admission, kg 
Medical History 
0 
All conditions listed in the “Past Medical History” 
section of the admission H&P note.  
Admitting diagnosis 
0 
Primary reason, collected from admission H&P 
Hospital unit 
0 
Location during study, 3SE, 3NE or 3NW 
Vital signs measurements 
0-1 
HR, RR, BP, temp, SpO2 
PEWS scores 
0-1 
 
Safety events – code blue, 
rapid response, unplanned 
transfer 
0-1 
Gathered from event or transfer notes. Type of 
event, date, time.  
 
Sleep diary and survey: Participants will complete the sleep diary and survey as described 
above in a paper form. The CRC will transcribe the paper responses into the RedCap CRF.  
 
Actigraphy: Actigraphy records will be uploaded onto a secure Intermountain computer. 
Variables of interest will be transcribed into the RedCap CRF.  
 
Every precaution will be taken to protect the privacy of research subjects and the confidentiality 
of their personal information.  The Principal Investigator, Intermountain Regulatory Specialists 
and Clinical Research Coordinator will maintain all patients’ information supplied by the clinical 
investigators in accordance with Health Insurance Portability and Accountability Act of 1996 
(HIPAA) and Intermountain Healthcare’s guidelines for compliance and privacy. For example, 
the patient files will be secured at Primary Children’s Hospital, using alphanumeric codes to 
identify each subject (sequential number + first letter of first, middle and last names: 001 ABC).  
  
7.2 
Sample Size Calculation 
 

 
18 
To detect a moderate effect size (Cohen’s d=0.50) difference between the intervention and 
comparison group with adequate power (β=.80) and a significance criterion of α=.05, a sample 
size of 128 (64 in each group) is needed. We will aim to enroll 80 children in each group to allow 
for participant attrition due to unexpected change in clinical status, dropout, or incomplete 
outcome data.  
 
Considering that prior studies demonstrated an in-hospital total sleep time of m(SD)=412(73.3) 
by actigraphy (Meltzer, Walsh et al., 2012), an effect size of d=0.5 equates to an increase in 
sleep of approximately 37 minutes (Becker, 2000).  
 
7.3 
Evaluation Endpoints 
 
7.3.1 Primary Endpoint 
 
The primary endpoint is total sleep time, as measured by actigraphy.  
 
7.3.2 Secondary Endpoints 
 
The secondary endpoints are as follow: 
- 
Nocturnal wake frequency, nocturnal wake duration (actigraphy) 
- 
Self-reported total sleep time (sleep diary) 
- 
Self-reported overnight disruptions (sleep diary) 
- 
Self-reported restfulness upon waking (sleep diary) 
- 
Self-reported sleep disturbances (sleep disturbance survey) 
 
7.4 
Statistical Analysis 
 
7.4.1 Populations for Analysis 
 
All children with at least one night of complete actigraphy data will be included.  
 
7.4.2 Statistical Methods 
 
Independent samples T tests and Chi square tests will be used to compare continuous and 
nominal data, respectively, between the case and control group. If continuous data do not meet 
the assumptions needed for a T test, namely normal distribution, a Mann-Whitney U test will be 
used instead.  
 
 
8.0 DISSEMINATION OF RESULTS 
 
8.1 
Release of Information to Participants 
 
Whenever possible within the limits of the study, effort will be made to keep study participants 
informed of significant study results.  This will mainly be a 1:1 discussion between the subject 
and Principal Investigator, as appropriate.  All other results will be considered for research only 
and will not be shared with the individual subject directly.   
 
Other methods of informing participants may also include web announcements or press 
releases. IRB approval will be obtained prior to use of any method for study progress 
information dissemination to participants. 

 
19 
 
8.2 
Public Release of Information 
 
Methods of disseminating study results and/or study progress to the public may include web 
announcements or press releases/newsletters.  IRB approval will be obtained prior to use of any 
method for information dissemination to the public. 
 
Requests for interviews, comments, or press conferences with the study investigators will be 
honored to more fully describe the results or explain the implications of the results, following 
consultation with the Intermountain public relations team.  Any direct request to the investigators 
will be sent to the public relations team first, before the investigator responds to the media 
request. 
 
8.3 
Data-Sharing with Collaborators 
Iris section 10.5 
• The results of this study will be shared with the University of Utah as per the 
clinical research agreement and as defined in the informed consent document. 
The physicians in this study team are employed by the University of Utah and 
sharing data is necessary for ensuring safety of the participants and study 
monitoring.  
 
The CRF will be fully deidentified. The study team will assign each participant an identifier as 
described in section 7.1. A separate record will be maintained that links the study identifier to 
the patients identifying information. All study data will be maintained on a secure Intermountain 
server, and the CRF will be maintained on a secure electronic data capture platform (RedCap). 
Information will be shared either via login to the study RedCap or encrypted email. Data may be 
reidentified if needed to evaluate safety events.  
 
All shared data will be de-identified as per the Privacy Rule of the NIH (National Institutes of 
Health, 2007) and in accordance with Intermountain policies.  
 
8.4 
Publications 
The results of this study may be published as a paper, abstract or poster, or may be presented 
orally at a conference or symposium.  Any publication resulting from this study will comply with 
the guidelines recommended by the International Council of Medical Journal Editors (i.e., 
Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in 
Medical Journals, 2013). 
 
9.0 FINANCIAL CONSIDERATIONS 
 
9.1 
Funding Source 
Iris section 13.1 
This study is funded by The Intermountain Foundation at Primary Children’s Hospital 
 
The tests and procedures listed below are considered non-standard of care and will be paid for 
by the study budget.  All other tests, procedures, and study visits are either conducted by study 
personnel (e.g. questionnaire administration, etc.) or charged to the patient as routine, standard 
of care activities.  The budget, contract and financial agreements will be available in a separate 
document.  
 

 
20 
Non-standard of care tests and procedures covered by the study budget are as follows: 
• 
Actigraphy watch sleep measurement 
• 
Survey administration 
 
9.2 
Compensation 
Iris section 7.4 
Subjects will not receive any monetary or other forms of compensation for participating in this 
research study. 
 
Likewise, the investigators and their research staff will not receive any monetary or other forms 
of direct compensation for conducting this research study. Payment is made directly to 
Intermountain Healthcare to cover the costs of study conduct. 
 
9.3 
Disclosure of Conflicts of Information 
Iris section 13.3 
The Principal Investigator, Sub-Investigators and protocol authors declare that they have no 
conflicts of interest relevant to this study. 
 

 
21 
 
10.0 
REFERENCES 
 
Agulnik, A., Méndez Aceituno, A., Mora Robles, L. N., Forbes, P. W., Soberanis Vasquez, D. J., 
Mack, R., Antillon-Klussmann, F., Kleinman, M., & Rodriguez-Galindo, C. (2017). Validation of a 
pediatric early warning system for hospitalized pediatric oncology patients in a resource-limited 
setting. Cancer, 123(24), 4903–4913. https://doi.org/10.1002/cncr.30951 
 
American Academy of Nursing. (2015). American Academy of Nursing announced engagement 
in National Choosing Wisely Campaign. Nurs Outlook. 2015;63(1):96-98.     
 
Becker, L.A. (2000, March 20). Effect Size Calculators. https://lbecker.uccs.edu/  
 
Bitterfeld, L., Mathias, J., Waldron, B. P., & Kranz, C. (2023). Understanding the effects of 
overnight vital signs monitoring on sleep duration and disruptions in hospitalized children: A 
scoping review. Journal of Pediatric Nursing, S0882-5963(23)00180-X. Advance online 
publication. https://doi.org/10.1016/j.pedn.2023.07.002 
 
Carney, C. E., Buysse, D. J., Ancoli-Israel, S., Edinger, J. D., Krystal, A. D., Lichstein, K. L., & 
Morin, C. M. (2012). The consensus sleep diary: standardizing prospective sleep self-
monitoring. Sleep, 35(2), 287–302. https://doi.org/10.5665/sleep.1642  
 
Chong, S. L., Goh, M. S. L., Ong, G. Y., Acworth, J., Sultana, R., Yao, S. H. W., Ng, K. C., & 
International Liaison Committee on Resuscitation (ILCOR) and ILCOR Pediatric Life Support 
Task Force (2022). Do paediatric early warning systems reduce mortality and critical 
deterioration events among children? A systematic review and meta-analysis. Resuscitation 
plus, 11, 100262. https://doi.org/10.1016/j.resplu.2022.100262 
 
Cook, D. J., Arora, V. M., Chamberlain, M., Anderson, S., Peirce, L., Erondu, A., Ahmed, F., 
Kilaru, M., Edstrom, E., Gonzalez, M., Ridgeway, R., Stanly, S., LaFond, C., Fromme, H. B., 
Clardy, C., & Orlov, N. M. (2020). Improving hospitalized children's sleep by reducing excessive 
overnight blood pressure monitoring. Pediatrics, 146(3), e20192217. 
https://doi.org/10.1542/peds.2019-2217  
 
Crawford, S., Utt, A., Beebe, C., Armbruster, R., Fisher, A., Olney, A., Sherman, A. K., & 
Roberts, C. (2019). Quality of sleep in a pediatric hospital: a descriptive study based on an 
assessment of interruptions, perceptions, and the environment. The Journal of nursing 
administration, 49(5), 273–279. https://doi.org/10.1097/NNA.0000000000000750  
 
Forrest, C. B., Meltzer, L. J., Marcus, C. L., de la Motte, A., Kratchman, A., Buysse, D. J., 
Pilkonis, P. A., Becker, B. D., & Bevans, K. B. (2018). Development and validation of the 
PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep, 41(6), 
10.1093/sleep/zsy054. https://doi.org/10.1093/sleep/zsy054 
 
Herbert, A. R., de Lima, J., Fitzgerald, D. A., Seton, C., Waters, K. A., & Collins, J. J. (2014). 
Exploratory study of sleeping patterns in children admitted to hospital. Journal of paediatrics and 
child health, 50(8), 632–638. https://doi.org/10.1111/jpc.12617 
 
Hillman D. R. (2021). Sleep loss in the hospitalized patient and its influence on recovery from 
illness and operation. Anesthesia and analgesia, 132(5), 1314–1320. 
https://doi.org/10.1213/ANE.0000000000005323     

 
22 
 
Lee, C. C., Savage, N. M., Wilson, E. K., Brigle, J., Poliakoff, D., Shah, R., & Lowerre, T. (2021). 
Sleeping safely! A quality improvement project to minimize nighttime interruptions without 
compromising patient care. Pediatric quality & safety, 6(3), e404. 
https://doi.org/10.1097/pq9.0000000000000404 
  
Lin, H. M., Macias, C., McGee, C., Ribbeck, M., Drees, D., Koti, A., & Perry, M. F. (2022). "Help 
me sleep": A quality initiative to reduce overnight vital signs. Hospital pediatrics, 12(2), 142–147. 
https://doi.org/10.1542/hpeds.2021-006250 Mann D. L. (2019). Q4 vital signs: Can machine 
learning protect patients from the machinery of modern medicine?. JACC. Basic to translational 
science, 4(3), 468–469. https://doi.org/10.1016/j.jacbts.2019.05.002 
 
Mazza S, Bastuji H, Rey AE. Objective and Subjective Assessments of Sleep in Children: 
Comparison of Actigraphy, Sleep Diary Completed by Children and Parents' Estimation. Front 
Psychiatry. 2020;11:495. Published 2020 Jun 10. doi:10.3389/fpsyt.2020.00495  
Meltzer, L. J., Davis, K. F., & Mindell, J. A. (2012). Patient and parent sleep in a children's 
hospital. Pediatric nursing, 38(2), 64–72.  
 
Meltzer, L. J., Montgomery-Downs, H. E., Insana, S. P., & Walsh, C. M. (2012). Use of 
actigraphy for assessment in pediatric sleep research. Sleep medicine reviews, 16(5), 463–475. 
https://doi.org/10.1016/j.smrv.2011.10.002  
  
Meltzer, L. J., Walsh, C. M., Traylor, J., & Westin, A. M. (2012). Direct comparison of two new 
actigraphs and polysomnography in children and adolescents. Sleep, 35(1), 159–166. 
https://doi.org/10.5665/sleep.1608  
 
Meltzer, L. J., Forrest, C. B., de la Motte, A., & Bevans, K. B. (2020). Clinical Validity of the 
PROMIS Pediatric Sleep Measures across Populations of Children with Chronic Illnesses and 
Neurodevelopment Disorders. Journal of pediatric psychology, 45(3), 319–327. 
https://doi.org/10.1093/jpepsy/jsz088 
 
Schrimpf, M., Liegl, G., Boeckle, M., Leitner, A., Geisler, P., & Pieh, C. (2015). The effect of 
sleep deprivation on pain perception in healthy subjects: a meta-analysis. Sleep medicine, 
16(11), 1313–1320. https://doi.org/10.1016/j.sleep.2015.07.022    
 
Stremler, R., Micsinszki, S., Adams, S., Parshuram, C., Pullenayegum, E., & Weiss, S. K. 
(2021). Objective sleep characteristics and factors associated with sleep duration and waking 
during pediatric hospitalization. JAMA network open, 4(4), e213924. 
https://doi.org/10.1001/jamanetworkopen.2021.3924    
 
Vriend, J., Davidson, F., Rusak, B., & Corkum, P. (2015). Emotional and cognitive impact of 
sleep restriction in children. Sleep medicine clinics, 10(2), 107–115. 
https://doi.org/10.1016/j.jsmc.2015.02.009     
 
 
 
 

 
23 
11.0 
    APPENDICES 
 
Appendices A to D are standard appendices to be attached to all protocols for clinical studies to 
be conducted at Intermountain CVR.  Standard statements are suggested below.  As 
appropriate, changes can be made to fit the needs of the clinical study. 
 
The researcher is advised not to delete any of the standard appendices in this protocol 
template.  These appendices serve as an information source, as well as a reminder of what the 
Study Team must be aware of, during the study conduct.  In the instance that an appendix is 
assessed as not necessary or not relevant (e.g., for data-only studies), enter “Not Applicable” 
under the specific appendix.  Other appendices can be added, for efficiency or clarification 
purposes.   
 
Examples of documents, tools, information, collection forms, etc. that can go into an appendix:  
• 
Investigator agreement document  
• 
Flow charts for the randomization sequence or procedures that must be performed for 
every subject  
• 
Instruction sheets for treatment regimen or special procedures  
• 
Patient questionnaires  
• 
Subject recruitment plan  
• 
Statistical analysis plan 
 
Ideally, study-specific patient questionnaires/surveys can be developed as documents separate 
from the protocol.  This will prevent inconsistencies when the protocol and/or questionnaire 
is/are revised independently. 
 
 
 
 
 

 
24 
APPENDIX A:  STUDY TOOLS AND INVESTIGATIONAL PRODUCT INFORMATION  
 
 
Appendix A-1 PEWS Score Tool 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
25 
Appendix A2 
 
 
 
Micro  
Motionlogger® Watch 
 
 
 
 
 The Excellence of a 
Motionlogger® 
 
✓ The highest agreement 
with PSG 
✓  2 Mb Non-Volatile 
Memory 
✓  Multiple Modes of 
Operation 
✓ Temperature Channel 
✓ Ambient Light Channel 
✓  Off-Wrist Detection 
✓  Event Marking with 
Visual Feedback 
✓  Status indicator 
✓  30 day runtime  
 No Interface Required (for IR 
enabled devices) 
  
PLUS a Watch 
 
 
✓  Rugged Plastic Case 
✓  Water Resistant – 100M  
✓  Date Display 
✓  Time Display Adjust 
Feature 
✓  Easy Battery Changing 
 
 
 
info@ambulatory-monitoring.com 
www.ambulatory-monitoring.com 

 
26 
Sleep Scoring Details 
 
The Sadeh (age>1 year) or Sadeh infant (age<1 year) algorithm using one minute epochs will 
be used to automatically score the data. For children that have more than one sleep period, 
based on sleep diary response, where the additionally periods are not automatically captured, 
they will be manually marked and then automatically scored. 
 
The collected variables will be: 
- 
Sleep minutes (total if>1 sleep period) 
- 
Sleep efficacy (mean if >1 sleep period) 
- 
Wake after sleep onset (total if>1 sleep period) 
- 
Wake episodes (total if>1 sleep period) 
- 
Mean wake episode (mean if >1 sleep period) 
- 
Mean lux (mean if >1 sleep period) 
- 
Mins > 20 lux (total if>1 sleep period) 
- 
Sleep onset latency (mean if>1 sleep period) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
27 
Appendix A-3i Patient Version Sleep Diary 
 
 
 
 
 
 
 
 
 
 
Study ID
________________
Date 
__ /__ /__ 
I fell asleep at:
AM / PM
I woke up at:
AM / PM
I woke up during the night:
# of times
# of minutes 
(total)
When I woke up for the day I felt:
Rested
o
Somewhat rested
o
Tired
o
Hours slept (to be completed by study staff)

 
28 
Appendix A-3ii. Parent Version Sleep Diary 
 
 
 
 
 
 
 
 
 
 
Study ID
________________
Date 
__ /__ /__ 
My child fell 
asleep at:
AM / PM
My child woke up 
at:
AM / PM
My child woke up during the night:
# of times
# of minutes 
(total)
When my child woke up for the day they felt:
Rested
o
Somewhat rested
o
Tired
o
Hours slept (to be completed by study staff)

 
29 
Appendix A-4 Sleep Disturbance Survey 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Last night…
Never
Almost 
Never
Sometimes
Almost 
Always
Always
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
I tossed and turned at night
Pediatric Sleep Disturbance Survey
Please respond to each question or statement by marking one box per row.
I had difficulty falling asleep
I slept through the night
I had a problem with my sleep
I had trouble sleeping
It took me a long time to fall asleep
I worried about not being able to fall 
asleep
I woke up at night and had trouble 
falling back to sleep
Last night…
Never
Almost 
Never
Sometimes
Almost 
Always
Always
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
q
My child tossed and turned at night
My child had a problem with my sleep
My child had trouble sleeping
It took my child a long time to fall asleep
My child worried about not being able 
to fall asleep
My child woke up at night and had 
trouble falling back to sleep
Pediatric Sleep Disturbance Survey - Parent Version
Please respond to each question or statement by marking one box per row.
My child had difficulty falling asleep
My child slept through the night

 
30 
PROMIS Sleep Disturbance Survey T-score conversion table 
 
Sleep Disturbance Child-Report 
Look-Up Table 
SF8 
Raw Score 
T Score 
T Score SE 
8 
36.6 
5.6 
9 
42.1 
3.8 
10 
44.8 
3.4 
11 
46.8 
3 
12 
48.5 
2.8 
13 
50 
2.6 
14 
51.3 
2.5 
15 
52.5 
2.5 
16 
53.7 
2.4 
17 
54.9 
2.4 
18 
56 
2.4 
19 
57.1 
2.5 
20 
58.2 
2.5 
21 
59.3 
2.5 
22 
60.3 
2.5 
23 
61.4 
2.5 
24 
62.4 
2.5 
25 
63.5 
2.5 
26 
64.5 
2.5 
27 
65.6 
2.5 
28 
66.6 
2.4 

 
31 
Look-Up Table 
SF8 
Raw Score 
T Score 
T Score SE 
29 
67.6 
2.4 
30 
68.7 
2.4 
31 
69.7 
2.4 
32 
70.7 
2.4 
33 
71.8 
2.5 
34 
72.9 
2.5 
35 
74.1 
2.6 
36 
75.4 
2.7 
37 
76.8 
2.9 
38 
78.5 
3.1 
39 
80.3 
3.3 
40 
82.7 
3.5 

 
32 
Appendix B:   Safety-Related Events 
 
Safety-related events information, as defined by ICH Good Clinical Practice guidelines (E6) 
(ICH GCP E6), the Code of Federal Regulations (CFR), and Intermountain research policy,  ( 
standard operating procedures (SOPs), will be collected throughout the study and will be 
reported using the appropriate case report forms, in accordance with relevant 
regulations/guidelines and Intermountain policy.   
 
Adverse Events 
All adverse events related to the subject’s participation in the research (serious and non-
serious, anticipated and unanticipated) will be assessed and recorded by the Principal 
Investigator and/or his/her delegate (, Sub-Investigators, Clinical Research Coordinator, etc), as 
per reporting timelines set forth by the guidelines, policies and regulations mentioned above.  
The Principal Investigator or his/her delegate will follow all adverse events until they are 
adequately resolved or explained.  The follow-up process and actions taken will be appropriately 
documented on the source documents and/or progress notes. 
 
Serious Adverse Events and Death 
The Principal Investigator or his/her delegate must decide whether a safety-related event meets 
the definition of a "serious" adverse event, guided by ICH GCP E6 and CFR definitions.  
Further, the Principal Investigator will collaborate with attending physicians and exercise their 
medical and scientific judgment in deciding whether important medical events, other than those 
defined by ICH GCP E6 and/or CFR, should be considered as serious adverse events.  
 
Anticipated Adverse Events 
Anticipated adverse events include: no anticipated adverse events.  
 
Unanticipated Problems Involving Risks to Subjects or Others 
Any event that meets all the following criteria is considered an Unanticipated Problem Involving 
Risk to Subjects or Others (UP).  This includes both adverse events and other types of 
incidences, experiences and outcomes that occur during the conduct of a research study.  
These events generally will warrant consideration of substantive changes in the research 
protocol or informed consent process/document or other corrective actions, to protect the safety, 
welfare, or rights of subjects or others: 
 
• 
Unexpected – considering the research procedures described in the protocol, 
investigator’s brochures and informed consent documents, and in consideration of the 
characteristics of the study population; 
• 
Is related or possibly related to the subject’s participation in the research; and 
• 
Suggests that the research places subjects or others at greater risk of harm than was 
previously known or recognized. 
 
 The Principal Investigator must report UPs that are not adverse events to the IRB within 10 
business days/14 calendar days.  
 

 
33 
 
APPENDIX C:   OTHER OVERSIGHT  
 
 
Data and Safety Monitoring Board 
A Data and Safety Monitoring Board (DSMB) will not be used for this study.  The Principal 
Investigator and his research team will monitor subject safety in accordance with ICH GCP E6, 
CFR, Declaration of Helsinki, Intermountain policies, Intermountain CVR SOPs, and all 
applicable local regulations.  
 
 
 
 

 
34 
APPENDIX D:   DECLARATION OF HELSINKI 
 
 
WMA Declaration of Helsinki – 
Ethical Principles for Medical Research Involving Human Subjects 
 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 
and amended by the: 
29th WMA General Assembly, Tokyo, Japan, October 1975 
35th WMA General Assembly, Venice, Italy, October 1983 
41st WMA General Assembly, Hong Kong, September 1989 
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 
52nd WMA General Assembly, Edinburgh, Scotland, October 2000  
53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification 
added) 
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 
59th WMA General Assembly, Seoul, Republic of Korea, October 2008 
64th WMA General Assembly, Fortaleza, Brazil, October 2013 
 
Preamble 
 
1.         The World Medical Association (WMA) has developed the Declaration of Helsinki as a 
statement of ethical principles for medical research involving human subjects, including 
research on identifiable human material and data. 
            The Declaration is intended to be read as a whole and each of its constituent 
paragraphs should be applied with consideration of all other relevant paragraphs. 
 
2.         Consistent with the mandate of the WMA, the Declaration is addressed primarily to 
physicians. The WMA encourages others who are involved in medical research involving human 
subjects to adopt these principles.  
 
General Principles 
 
3.         The Declaration of Geneva of the WMA binds the physician with the words, “The health 
of my patient will be my first consideration,” and the International Code of Medical Ethics 
declares that, “A physician shall act in the patient's best interest when providing medical care.” 
 
4.         It is the duty of the physician to promote and safeguard the health, well-being and rights 
of patients, including those who are involved in medical research. The physician's knowledge 
and conscience are dedicated to the fulfilment of this duty. 
 
5.         Medical progress is based on research that ultimately must include studies involving 
human subjects. 
 
6.         The primary purpose of medical research involving human subjects is to understand the 
causes, development and effects of diseases and improve preventive, diagnostic and 
therapeutic interventions (methods, procedures and treatments). Even the best proven 
interventions must be evaluated continually through research for their safety, effectiveness, 
efficiency, accessibility and quality. 
 

 
35 
7.         Medical research is subject to ethical standards that promote and ensure respect for all 
human subjects and protect their health and rights. 
 
8.         While the primary purpose of medical research is to generate new knowledge, this goal 
can never take precedence over the rights and interests of individual research subjects. 
 
9.         It is the duty of physicians who are involved in medical research to protect the life, 
health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal 
information of research subjects. The responsibility for the protection of research subjects must 
always rest with the physician or other health care professionals and never with the research 
subjects, even though they have given consent. 
 
10.       Physicians must consider the ethical, legal and regulatory norms and standards for 
research involving human subjects in their own countries as well as applicable international 
norms and standards. No national or international ethical, legal or regulatory requirement should 
reduce or eliminate any of the protections for research subjects set forth in this Declaration. 
 
11.       Medical research should be conducted in a manner that minimises possible harm to the 
environment. 
 
12.       Medical research involving human subjects must be conducted only by individuals with 
the appropriate ethics and scientific education, training and qualifications. Research on patients 
or healthy volunteers requires the supervision of a competent and appropriately qualified 
physician or other health care professional. 
 
13.       Groups that are underrepresented in medical research should be provided appropriate 
access to participation in research. 
 
14.       Physicians who combine medical research with medical care should involve their 
patients in research only to the extent that this is justified by its potential preventive, diagnostic 
or therapeutic value and if the physician has good reason to believe that participation in the 
research study will not adversely affect the health of the patients who serve as research 
subjects. 
 
15.       Appropriate compensation and treatment for subjects who are harmed as a result of 
participating in research must be ensured. 
 
Risks, Burdens and Benefits  
 
16.       In medical practice and in medical research, most interventions involve risks and 
burdens. 
           Medical research involving human subjects may only be conducted if the importance of 
the objective outweighs the risks and burdens to the research subjects. 
 
17.       All medical research involving human subjects must be preceded by careful assessment 
of predictable risks and burdens to the individuals and groups involved in the research in 
comparison with foreseeable benefits to them and to other individuals or groups affected by the 
condition under investigation. 
           Measures to minimise the risks must be implemented. The risks must be continuously 
monitored, assessed and documented by the researcher.  
 

 
36 
18.       Physicians may not be involved in a research study involving human subjects unless 
they are confident that the risks have been adequately assessed and can be satisfactorily 
managed. 
           When the risks are found to outweigh the potential benefits or when there is conclusive 
proof of definitive outcomes, physicians must assess whether to continue, modify or 
immediately stop the study.    
 
Vulnerable Groups and Individuals 
 
19.       Some groups and individuals are particularly vulnerable and may have an increased 
likelihood of being wronged or of incurring additional harm. 
           All vulnerable groups and individuals should receive specifically considered protection. 
20.       Medical research with a vulnerable group is only justified if the research is responsive to 
the health needs or priorities of this group and the research cannot be carried out in a non-
vulnerable group. In addition, this group should stand to benefit from the knowledge, practices 
or interventions that result from the research. 
 
Scientific Requirements and Research Protocols  
 
21.       Medical research involving human subjects must conform to generally accepted 
scientific principles, be based on a thorough knowledge of the scientific literature, other relevant 
sources of information, and adequate laboratory and, as appropriate, animal experimentation. 
The welfare of animals used for research must be respected. 
 
22.       The design and performance of each research study involving human subjects must be 
clearly described and justified in a research protocol. 
           The protocol should contain a statement of the ethical considerations involved and 
should indicate how the principles in this Declaration have been addressed. The protocol should 
include information regarding funding, sponsors, institutional affiliations, potential conflicts of 
interest, incentives for subjects and information regarding provisions for treating and/or 
compensating subjects who are harmed as a consequence of participation in the research 
study. 
           In clinical trials, the protocol must also describe appropriate arrangements for post-trial 
provisions. 
 
Research Ethics Committees 
 
23.       The research protocol must be submitted for consideration, comment, guidance and 
approval to the concerned research ethics committee before the study begins. This committee 
must be transparent in its functioning, must be independent of the researcher, the sponsor and 
any other undue influence and must be duly qualified. It must take into consideration the laws 
and regulations of the country or countries in which the research is to be performed as well as 
applicable international norms and standards but these must not be allowed to reduce or 
eliminate any of the protections for research subjects set forth in this Declaration.  
            
The committee must have the right to monitor ongoing studies. The researcher must 
provide monitoring information to the committee, especially information about any serious 
adverse events. No amendment to the protocol may be made without consideration and 
approval by the committee. After the end of the study, the researchers must submit a final report 
to the committee containing a summary of the study’s findings and conclusions.  
 

 
37 
Privacy and Confidentiality  
 
24.       Every precaution must be taken to protect the privacy of research subjects and the 
confidentiality of their personal information. 
 
Informed Consent  
 
25.       Participation by individuals capable of giving informed consent as subjects in medical 
research must be voluntary. Although it may be appropriate to consult family members or 
community leaders, no individual capable of giving informed consent may be enrolled in a 
research study unless he or she freely agrees. 
 
26.       In medical research involving human subjects capable of giving informed consent, each 
potential subject must be adequately informed of the aims, methods, sources of funding, any 
possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits 
and potential risks of the study and the discomfort it may entail, post-study provisions and any 
other relevant aspects of the study. The potential subject must be informed of the right to refuse 
to participate in the study or to withdraw consent to participate at any time without reprisal. 
Special attention should be given to the specific information needs of individual potential 
subjects as well as to the methods used to deliver the information. 
           After ensuring that the potential subject has understood the information, the physician or 
another appropriately qualified individual must then seek the potential subject’s freely-given 
informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-
written consent must be formally documented and witnessed.       
           All medical research subjects should be given the option of being informed about the 
general outcome and results of the study. 
 
27.       When seeking informed consent for participation in a research study the physician must 
be particularly cautious if the potential subject is in a dependent relationship with the physician 
or may consent under duress. In such situations the informed consent must be sought by an 
appropriately qualified individual who is completely independent of this relationship. 
 
28.       For a potential research subject who is incapable of giving informed consent, the 
physician must seek informed consent from the legally authorised representative. These 
individuals must not be included in a research study that has no likelihood of benefit for them 
unless it is intended to promote the health of the group represented by the potential subject, the 
research cannot instead be performed with persons capable of providing informed consent, and 
the research entails only minimal risk and minimal burden. 
 
29.       When a potential research subject who is deemed incapable of giving informed consent 
is able to give assent to decisions about participation in research, the physician must seek that 
assent in addition to the consent of the legally authorised representative. The potential subject’s 
dissent should be respected. 
 
30.       Research involving subjects who are physically or mentally incapable of giving consent, 
for example, unconscious patients, may be done only if the physical or mental condition that 
prevents giving informed consent is a necessary characteristic of the research  group. In such 
circumstances the physician must seek informed consent from the legally authorised 
representative. If no such representative is available and if the research cannot be delayed, the 
study may proceed without informed consent provided that the specific reasons for involving 
subjects with a condition that renders them unable to give informed consent have been stated in 

 
38 
the research protocol and the study has been approved by a research ethics committee. 
Consent to remain in the research must be obtained as soon as possible from the subject or a 
legally authorised representative. 
 
31.       The physician must fully inform the patient which aspects of their care are related to the 
research. The refusal of a patient to participate in a study or the patient’s decision to withdraw 
from the study must never adversely affect the patient-physician relationship. 
 
32.       For medical research using identifiable human material or data, such as research on 
material or data contained in biobanks or similar repositories, physicians must seek informed 
consent for its collection, storage and/or reuse. There may be exceptional situations where 
consent would be impossible or impracticable to obtain for such research. In such situations the 
research may be done only after consideration and approval of a research ethics committee. 
 
Use of Placebo 
 
33.       The benefits, risks, burdens and effectiveness of a new intervention must be tested 
against those of the best proven intervention(s), except in the following circumstances: 
           Where no proven intervention exists, the use of placebo, or no intervention, is 
acceptable; or 
           Where for compelling and scientifically sound methodological reasons the use of any 
intervention less effective than the best proven one, the use of placebo, or no intervention is 
necessary to determine the efficacy or safety of an intervention  
           and the patients who receive any intervention less effective than the best proven one, 
placebo, or no intervention will not be subject to additional risks of serious or irreversible harm 
as a result of not receiving the best proven intervention.  
           Extreme care must be taken to avoid abuse of this option. 
 
Post-Trial Provisions 
 
34.       In advance of a clinical trial, sponsors, researchers and host country governments 
should make provisions for post-trial access for all participants who still need an intervention 
identified as beneficial in the trial. This information must also be disclosed to participants during 
the informed consent process. 
 
Research Registration and Publication and Dissemination of Results 
 
35.       Every research study involving human subjects must be registered in a publicly 
accessible database before recruitment of the first subject. 
 
36.       Researchers, authors, sponsors, editors and publishers all have ethical obligations with 
regard to the publication and dissemination of the results of research. Researchers have a duty 
to make publicly available the results of their research on human subjects and are accountable 
for the completeness and accuracy of their reports. All parties should adhere to accepted 
guidelines for ethical reporting. Negative and inconclusive as well as positive results must be 
published or otherwise made publicly available. Sources of funding, institutional affiliations and 
conflicts of interest must be declared in the publication. Reports of research not in accordance 
with the principles of this Declaration should not be accepted for publication. 
 
Unproven Interventions in Clinical Practice 
 

 
39 
37.       In the treatment of an individual patient, where proven interventions do not exist or other 
known interventions have been ineffective, the physician, after seeking expert advice, with 
informed consent from the patient or a legally authorised representative, may use an unproven 
intervention if in the physician's judgement it offers hope of saving life, re-establishing health or 
alleviating suffering. This intervention should subsequently be made the object of research, 
designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, 
where appropriate, made publicly available. 
 
Disclaimer: © 2013 World Medical Association, Inc. All Rights Reserved. All intellectual property 
rights in the Declaration of Helsinki are vested in the World Medical Association.  Previous 
permissions granted to publish or reproduce otherwise WMA policy don’t apply to this version of 
the Declaration of Helsinki until January 1st, 2014. For further questions, please contact the 
WMA secretariat at secretariat@wma.net. 
 

 
40 
12.0 
    PROTOCOL SIGNATURE PAGE 
 
  
PROTOCOL IDENTIFICATION  
 
[Insert protocol identification number, title and applicable short title or acronym here]  
 
 
PRINCIPAL INVESTIGATOR AGREEMENT  
 
I agree to conduct this clinical trial/research study in accordance with the design and specific 
provisions of this protocol.  Deviations from the protocol are acceptable only with a mutually 
agreed upon protocol amendment and approval by the Institutional Review Board (IRB).  I also 
agree to report all information or data in accordance with the protocol.  I agree to report any 
serious adverse experiences as defined in the Safety Reporting section of this protocol to the 
Intermountain IRB, and in accordance with the IRB’s reporting requirements.  I also agree to 
handle all clinical supplies provided by the sponsor, and collect and handle all biological 
specimens, in accordance with the protocol.  
 
 
 
____________________ 
____________________ 
____________________ 
Principal Investigator  
Principal Investigator  
              Date 
(Printed Name) 
 
(Signature) 
 
 
 
 
 
If there are Co-Principal Investigators designated for this study, they must also affix their 
dated signatures below:  
 
 
 
____________________ 
____________________ 
____________________ 
Co-Principal Investigator 
Co-Principal Investigator 
 
   Date 
(Printed Name) 
 
(Signature) 
 
 
 
____________________ 
____________________ 
____________________ 
Co-Principal Investigator 
Co-Principal Investigator 
 
   Date 
(Printed Name) 
 
(Signature)