Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sponsor: Washington University School of Medicine

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
RESEARCH PROTOCOL 
 
 
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory 
Polysomnography in Pediatric Patients 
 
 
 
 
David S. Leonard, MD 
Assistant Professor, Otolaryngology 
dsleonard@wustl.edu 
 
James Kemp, MD 
Professor, Pediatrics 
Division of Pediatric Allergy, Immunology and Pulmonary Medicine 
Director, Sleep Laboratory, St. Louis Children's Hospital 
Kemp_J@kids.wustl.edu  
 
 
 
Michael McLeland, Ph.D., RPSGT, RST 
Coordinator Sleep Lab, St. Louis Children’s Hospital 
Michael.McLeland@bjc.org 
 
Michael C. Montana, MD, PhD 
Faculty Instructor, Pediatric Anesthesiology 
montana@wustl.edu 
 
 
 
 
 
Version 1.2 
April, 18, 2019 
NCT03473548 
 
 

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
SYNOPSIS 
Study Title 
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory 
Polysomnography in Pediatric Patients 
Objectives 
1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea 
hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored 
polysomnography and in-laboratory polysomnography in pediatric patients. 
Study Period 
2 years 
Number of Subjects 
100 children, ages 5 to 12 years of age  
Study Design 
Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study 
Inclusion and Exclusion 
Criteria 
Inclusion Criteria 
a) 5- to 12-years-old 
b) Parental informed consent 
c) Suspected Sleep Disordered Breathing 
 
Exclusion Criteria 
a) Developmental delay 
b) Use of home oxygen 
c) History of Parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism) 
d) History of tracheal surgery  
e) History of tracheal stenosis 
f) 
History of Nocturnal Hypoventilation 
g) History of Central Sleep Apnea 
h) Use of a Ventilatory Assist Device (e.g. Non-Invasive Positive Pressure Ventilation) 
Measurements 
An unattended at-home overnight sleep study using a Type III portable monitor 
(polysomnography) will be performed on all subjects. All subjects will also have an inpatient, 
Type I monitored polysomnography performed in the St. Louis Children’s Hospital Sleep 
Laboratory. For both studies the Apnea-Hypopnea Index, Average SPO2, and SPO2 nadir 
will be determined.  
Outcomes 
Primary outcome will be the feasibility of obtaining greater than or equal to 6 hours of data 
adequate for polysomnography analysis and determination of an apnea hypopnea index 
(AHI), average SPO2, and SPO2 nadir using un-attended polysomnography. Secondary 
outcomes will be the comparison of AHI, average SPO2, and SPO2 nadir between 
unattended and inpatient polysomnography. An exploratory outcome will be a comparison 
of the McGill Oximetry Score between unattended and inpatient polysomnography. 
 

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
1. Background and Rationale: Childhood obstructive sleep apnea (OSA), defined by periodic, 
partial or complete obstruction of the upper airway during sleep, is a common disorder in 
pediatric patients. The prevalence of OSA in children is as high as 5%, and if untreated, OSA 
can result in significant deleterious behavioral, cognitive, and cardiovascular consequences 1. 
First line treatment for pediatric OSA is tonsillectomy and adenoidectomy. This surgery is 
estimated to be curative in approximately 60% of patients, and even in patients where a 
complete cure is not achieved there is a significant reduction in symptoms in most cases 2. 
Given the high prevalence and excellent treatment options, it is important that if OSA is 
suspected a diagnosis is made accurately and efficiently.  
The current gold standard for the diagnosis of OSA is in-laboratory polysomnography 
(PSG), otherwise known as a Type I sleep study. However, in-laboratory PSG is expensive and 
time consuming as tests are administered by individuals specially trained in sleep medicine in 
an outpatient setting, and include seven or more channels to monitor sleep, cardiovascular 
parameters, oximetry, patient position, respiratory effort, and breathing. Furthermore, due to 
regional variations in sleep center locations, patients do not uniformly have access to centers 
that perform in-laboratory PSGs. Thus, there has been considerable interest in developing and 
validating methods to perform home sleep apnea testing, also known as portable monitoring. 
Indeed, the American Academy of Sleep Medicine (AASM) has recommended the use of 
portable monitoring as an alternative to in-laboratory PSG for the diagnosis of OSA in selected 
adult patients 3.  
Type II studies are similar to Type I studies except they are not attended by a specially 
trained individual and can be administered in a subject’s home. Type III portable monitoring 
uses fewer channels (generally 4 to 7) to obtain data than does in-laboratory PSGs, and does 
not usually have a registered sleep technologist present during the study. In certain 
circumstances this may reduce the fidelity of the data collected. However, portable monitoring 
has several advantages over in-laboratory PSGs, including reduced cost, increased patient 
accessibility, and critically, the ability to assess a more typical night’s sleep, since the subject is 
sleeping in their own home instead of an unfamiliar sleep laboratory. However, while approved 
for adults, the latest guidelines on childhood OSA published by the American Academy of 
Pediatrics in 2012 concluded that there is insufficient data in children to either support or refute 
the utility of portable monitoring in the diagnosis of pediatric OSA 4,5. Several studies have 
demonstrated the feasibility of both Type II and Type III portable monitoring in children across 
multiple age ranges 1,4-6, however direct comparison between portable monitoring and in-
laboratory attended PSG in children is limited 1,6, and to quote the 2012 guidelines, “… 
additional studies of ambulatory PSG in children of varying ages are needed.” In addition, 
continued technological advances in sleep monitor design has decreased the size of 
commercially available sleep monitors to the point that some are now size-appropriate for 
pediatric patients.  
 
The purpose of the study proposed below is twofold. First we will test the feasibility of 
conducting portable sleep monitoring in school aged children using the Clevemed Sleepview 
(www.clevelmed.com), one of the smallest portable sleep monitors commercially available at 57 
grams. Second we will perform a direct comparison between the results obtained with this 
portable sleep monitor and those obtained from a standard-of-care in-laboratory attended sleep 
study performed at the St. Louis Children’s Hospital Pediatric Sleep Center. These comparisons 
will be offered to the families of school age children suspected of having sleep disordered 
breathing who present to the Washington University Pediatric Otolaryngology Department. We 
hypothesize that in-laboratory attended polysomnography and portable monitoring will yield 
similar results in the diagnosis of sleep disordered breathing in school aged pediatric patients. 
These initial comparisons will be conducted in otherwise healthy children. Future studies will 
expand this comparison to children with underlying comorbidities, including younger children 
and those with developmental delay. 

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
 
2. Enrollment: Patients and their families who present to the Washington University 
Department of Pediatric Otolaryngology with a suspected diagnosis of sleep disordered 
breathing will be given information regarding the study in the otolaryngologist’s office. A member 
of the research team will approach the patient and their family once they are identified as 
needing an in-laboratory sleep study as part of their work up for sleep disordered breathing. 
Written informed consent will be obtained from the patient’s family and assent will be obtained 
from the patient at that time. The study group will consist of one hundred patients who require 
diagnostic PSG for sleep disordered breathing. Inclusion and exclusion criteria are based on 
independent risk factors for respiratory complications following tonsillectomy and 
adenoidectomy 7. The Washington University Pediatric Otolaryngology clinic sees approximately 
100 patients a month with tonsillar hypertrophy, snoring, or other concerns for sleep disordered 
breathing that would warrant a sleep study; the St. Louis Children's Hospital Sleep Laboratory 
performs approximately 1300 Type I sleep studies a year. We plan to enroll 125 patients in this 
study, assuming a 20% drop out rate from the study, with an end goal of one hundred study 
patients. Given the frequency with which patients present with concern for sleep disordered 
breathing this should be accomplishable in the planned time frame.  
 
3. Eligibility: 
 
3.1. Inclusion Criteria 
3.1.1. 5- to 12-years-old 
3.1.2. Parental informed consent 
3.1.3. Suspected Sleep Disordered Breathing 
 
3.2. Exclusion Criteria 
3.2.1. Developmental delay 
3.2.2. Use of home oxygen 
3.2.3. History of Parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism) 
3.2.4. History of tracheal surgery  
3.2.5. History of tracheal stenosis 
3.2.6. History of Nocturnal Hypoventilation 
3.2.7. History of Central Sleep Apnea 
3.2.8. Use of a Ventilatory Assistant Device 
 
4. Methods:  
4.1. Study design:  Single-center, un-blinded, feasibility, and methods comparison study 
 
4.2. Otolaryngology Clinic Assessment: Subjects will be identified from patients presenting to 
the Washington University in St. Louis Pediatric Otolaryngology Clinic who are suspected of 
having sleep disordered breathing. Subjects who are identified by an attending otolaryngologist 
as requiring polysomnography as part of their work up will then be approached by a member of 
the research team who will explain the study to the subject and their family and obtain informed 
consent. During this visit, subjects will also be administered a short, validated sleep 
questionnaire, the Modified STOP-Bang Tool for Stratifying OSA Risk in Adolescent Children 9. 
This questionnaire is 8 questions and routinely administered in the Washington University 
Pediatric Otolaryngology offices. 
 
4.3.1. Unattended Polysomnography: All eligible subjects will be asked to conduct an 
unattended, overnight sleep study performed in their home prior to in-laboratory 
polysomnography, using a standard Type III portable monitor. This study will be performed with 

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
an FDA approved sleep monitor (e.g CleveMed SleepView or similar). Per American Academy 
of Sleep Medicine (AASM) guidelines, portable sleep monitoring will include air flow, respiratory 
effort, heart rate and blood oxygenation. Airflow will be measured using a nasal cannula and 
pressure transducer which is located within the home sleep test (HST) recording device. 
Respiratory effort will be recorded using Respiratory Inductance Plethysmography (RIP) belts 
that will go around the chest at the nipple line and around the abdomen at the navel level. Blood 
oxygenation and heart rate will be recorded by pulse oximetry that will be placed on one finger. 
Each study participant and their family will be shown and educated on how to apply each of the 
sensors by a member of the study team. Unattended sleep studies will be interpreted by an 
individual trained in sleep medicine. The first assessment of the Unattended sleep study for 
each individual patient will be readability of the recordings.  
 
Polysomnography testing will determine the apnea hypopnea index (AHI), blood 
saturation oxygen nadir (SPO2 nadir), and average blood oxygen saturation 3. The AHI is 
defined as the average number of hypopneas (episodes of decreased breathing) and apneas 
(episodes of cessation of breathing) per hour of sleep. Apneas and hypopneas will be defined 
per the American Academy of Sleep Medicine manual for scoring sleep and associated events 
10. The objective is to obtain greater than or equal to 6 hours of data adequate for 
polysomnography analysis and determination of an apnea hypopnea index (AHI), average 
SPO2, and SPO2 nadir using home un-attended polysomnography. 
 
A McGill Oximetry Score 11, which only uses the frequency and depth of SPO2 
desaturations throughout a night’s sleep to assign a score of 1 (normal/inconclusive), 2 (mildly 
abnormal), 3 (markedly abnormal), and 4 (severely abnormal) will be also be assigned to each 
home sleep test.  
Fidelity of data collection using at home sleep studies is reliable, but not 100% reliable 3. 
For example, subjects may unconsciously remove the nasal cannula or the finger pulse 
oximeter in their sleep, resulting in data drop outs. A subject’s parent or guardian will be 
requested to periodically monitor the subject throughout the night and be instructed on how to 
reapply sensors to minimize data drop outs. Should data from an initial sleep study be 
uninterpretable based on sleep study expert opinion we will ask the subjects to attempt the 
unattended sleep study an additional time. A recent study on the feasibility of Type II 
comprehensive (i.e. greater than 7 channel) pediatric sleep studies, reported that 91% of home 
sleep studies are successful on initial attempt and a total of 98% are successful after one repeat 
testing 12. A 2013 assessment of Type III sleep studies performed both in a hospital setting (26 
patients) and at home (75 patients) found that technically acceptable and interpretable studies 
were obtained from 93% of subjects 13. 
Should data from the second sleep study be uninterpretable we will not proceed with 
further testing of these subjects by home sleep study. Regardless of whether a subject 
successful completes home sleep testing, in-laboratory polysomnography will still be performed 
as part of their work up for sleep disordered breathing. 
 
4.3.2. Parental Monitoring Plan for Unattended Polysomnography: Parents will be instructed that 
while the device is FDA approved for use in adults it is not FDA approved in children and 
therefore they will need to monitor their child more closely during the night than they would have 
to during a typical night’s sleep. Parents should remain in close enough proximity to hear their 
child should their child call out for them during the night for assistance with any aspect of the 
device. Parents will be instructed that improper routing of leads may result in a choking hazard. 
Parents will be instructed to inspect for proper effort belt, nasal cannula, and pulse oximeter 
placement at least every two hours. Parents will be instructed that should they ever feel the 
device presents a significant choking hazard to their child they should entirely remove the 
device and stop the study.  
 

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
4.4. In-laboratory Polysomnography: All eligible subjects will have in-laboratory 
polysomnography as is routinely performed in the diagnostic work up for suspected sleep 
disordered breathing. The in-laboratory sleep study will be done at the St. Louis Children’s 
Hospital Pediatric Sleep Center, which is an American Academy of Sleep Medicine accredited 
sleep disorder center. The Center is sound-proof, and has been designed to provide as natural 
and home-like an atmosphere as possible. Infrared monitoring equipment allows for patient 
observation from outside of the patient’s sleep room. At least one parent is required to stay in 
the room overnight with the patient. A second parent can stay as well, but not required. The 
Center is located inside of St. Louis Children’s Hospital within an inpatient medical unit, which is 
staffed with physicians and nurses 24 hours per day.  
Per American Academy of Sleep Medicine (AASM) guidelines, in-laboratory sleep 
monitoring is attended by a specially trained technologist who sets up the sleep study, observes 
the subject throughout the duration of the sleep study, and is available to troubleshoot in real 
time any monitoring issues that may arise. In-laboratory polysomnography consists of 21 leads 
that measure electroencephalogram, electrocardiogram, air flow, respiratory effort, heart rate, 
activity, and blood oxygenation monitoring. In-laboratory sleep studies are scored by a trained 
Registered Polysomnographic Technologist or Registered Sleep Technologist and interpreted 
by a physician. Polysomnography testing will determine the sleep stages, apnea hypopnea 
index (AHI), blood saturation oxygen nadir (SPO2 nadir), and average blood oxygen saturation, 
as defined above 3. A McGill Oximetry Score will also be calculated for the in-laboratory PSG. 
 
4.6. Subject assessments: The unattended home polysomnogram will record blood oxygen 
concentration, pulse rate, respiratory effort, air flow and respiratory effort. The in-laboratory 
polysomnogram will record these parameters and will also measure electroencepholography, 
electrocardiogram, and heart rate. 
 
4.7. Conclusion of study: The study ends with the completion of the in-laboratory 
polysomnogram. Additionally, the study ends at any time the patient or parent/caregiver 
requests it to end. Appropriate treatment for any diagnosis of sleep disordered breathing will 
proceed based on the attending otolaryngologist recommendations. Recommendations and 
treatment will not be affected by participation in the investigation. As home sleep testing in 
pediatric patients is exploratory; only the in-laboratory sleep study will be used in making any 
diagnosis of sleep disordered breathing and in determining treatment options.    
 
5.  Data Collection and Monitoring 
5.1. Clinical Assessments: At the completion of both the unattended and in-laboratory 
polysomnography we will determine an Apnea-Hypopnea Index, Average SPO2, and SPO2 nadir 
for each subject. An assessment of the technical quality of each study will be made. The in-
laboratory polysomnogram will be scored and interpreted via standard practice for the St. Louis 
Children’s Hospital Pediatric Sleep Center and included in the patient’s medical record. The 
unattended polysomnogram will not be included in the patient’s medical record and will only be 
accessible to study team members.  
 
6. Outcome Measures 
7.1. Primary Outcome Measure: The feasibility of obtaining greater than or equal to 6 hours of 
data adequate for polysomnography analysis and determination of an apnea hypopnea index 
(AHI), average SPO2, and SPO2 nadir using home un-attended polysomnography. 
 
6.2. Secondary Outcome Measures 
6.2.1. Comparison of AHI between unattended and in-laboratory polysomnography 
6.2.2. Comparison of average SPO2 between unattended and in-laboratory polysomnography 

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
6.2.3. Comparison of SPO2 nadir between unattended and in-laboratory polysomnography 
6.2.4. Comparison of sleep disordered breathing diagnosis between unattended and in-
laboratory polysomnography 
 
6.3. Exploratory Outcomes Measure: Comparison of McGill Oximetry Scores between 
unattended and in-laboratory polysomnography. 
 
6.4. Analysis: The primary outcome is the feasibility of obtaining an adequate sleep study from 
unattended polysomnography in pediatric patients. Percentages of studies that have 6 hours of 
data sufficient for analysis will be reported. The study will be defined feasible if 85% or more of 
participants provide 6 or more hours of analyzable data. Descriptive statistics will be used to 
describe the AHI, SPO2 nadir, SPO2 average, and diagnosis obtained using each method. 
Continuous secondary outcome measures will be compared using paired-t tests or its non-
parametric equivalent Wilcoxon signed rank test. The Friedman test will be used to compare 
ordinal outcome measures. Agreement between home sleep testing and in-laboratory PSGs will 
also be compared using Bland-Altman Analysis 14. A General Linear Model Approach will be 
used to explore the role of potential confounders including age, sex, weight, and race 
differences when performing analyses. If our hypothesis is correct, home sleep studies will be 
feasible in our study population.  
 
7.  Potential Risks 
 
7.1. Unattended Polysomnography: There is minimal risk associated with the sleep study. Per 
AASM guidelines 3 unattended portable monitoring may be used to facilitate the diagnosis of 
OSA in adults and as such this is standard of care in that population. While no such 
recommendation for the use of unattended portable monitoring exists for pediatric patients, we 
will use an FDA approved device to perform the unattended polysomnography and patients and 
their families will be instructed in its use by a trained member of the research team. Patients and 
their families will also be provided a pictoral instruction manual on the proper application and 
use of the device. Family members will be instructed that the improper use of the device may 
present a choking hazard to their child. Family members will be instructed to listen out for their 
child throughout the night (for example by keeping bedroom doors open), and to check on their 
child for proper nasal cannula, effort belt, and pulse ox placement at least every two hours.  
Patients may experience mild discomfort from the ambulatory sleep monitoring devices. 
Patients’ family members may experience mild inconvenience during the setup of the sleep 
monitor, while monitoring of their child during the home sleep study, and should any trouble 
shooting be required during the time their child is asleep. Patients and their families may 
experience mild inconvenience if they are asked to perform a second sleep study due to results 
from the first study being uninterpretable.  
 
7.2. In-laboratory Polysomnography: This is standard of care in the diagnosis of pediatric sleep 
disordered breathing. The in-laboratory polysomnogram is being conducted in an AASM 
accredited sleep disorder center that conducts 1300 sleep studies per year and has been in 
continuous operation since 1993. There is minimal risk associated with in-patient 
polysomnography. Patients may experience mild anxiety and discomfort by sleeping in an 
unfamiliar place for one night.  
 
7.3 Steps Taken to Mitigate Risk: Studies are conducted under the supervision of the 
investigating physicians and personnel with specialty training in sleep medicine. Research team 
members are trained and experienced in performing research in human subjects, and in 
monitoring for adverse effects.  

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
Inclusion and exclusion criteria, monitoring, and the clinical protocol are designed to 
ensure that risks are absolutely minimal. Subjects and their families are informed that 
participation is voluntary and they may refuse to participate and may withdraw from the study at 
any time without penalty. Subjects will be told that in the unlikely event of a physical injury as 
the direct result of study procedures, they will be cared for by a member of the investigating 
team at no cost, within the limits of the Washington University compensation plan. 
During the unattended sleep study, there is minimal risk. Subjects will be in their own 
home and should the unattended sleep study equipment prove too much of a discomfort or too 
challenging for parents to maintain they will be free to remove the device at any time. A specific 
monitoring plan to minimize the possibility that the device could present a choking hazard is 
described above. In-laboratory, attended polysomnography is standard of care and as such 
carries minimal risk. 
Regarding confidentiality; 1) all subjects will be assigned a study ID number, and 2) 
unattended polysomnography reports will be kept confidentially. They will be coded, with 
information linking code numbers to names kept at a separate location, under lock and key. 3) 
The link to identifiers will be destroyed at the end of the study. 4) Data will be stored under lock 
and key (office, file cabinet) and only the investigators and research team will have access. If 
data are published, there will be no link to identifiers. Study data will not be revealed to any 
organization, individuals other than the subjects, or the subjects themselves. 5) Study data from 
the unattended polysomnography will not be entered in subjects' medical records.  
 
8. Management of Intercurrent Events 
8.1. Adverse Experiences 
The investigator will closely monitor subjects for evidence of adverse events. All adverse 
events will be reported and followed until satisfactory resolution. The description of the adverse 
experience will include the time of onset, duration, intensity, etiology, relationship to the study 
drug (none, unlikely, possible, probable, highly probable), and any treatment required. 
 
8.2. Premature Discontinuation 
If a subject withdraws from the study, the subject will be replaced to provide the required 
number of subjects. Subjects will be withdrawn if the investigator decides that discontinuation is 
in the best interest of the subject, or the subject requests withdrawal from the study. 
 
9.  Data and Safety Monitoring Plan 
Studies conducted in the Departments of Pediatrics, Otolaryngology, and 
Anesthesiology follow the Washington University Institutional Review Board Policies and 
Procedures (last revision April 20, 2015). All individuals working on the study are required to 
read and be familiar with and compliant with the IRB Policies and Procedures. The specific 
monitoring plan for this investigation is commensurate with the risks and the size and complexity 
of the investigations planned. The potential risks are attributable to performing unattended 
polysomnography. Based on the small size and relatively low risk nature of the protocol, the 
investigating physicians are involved in the monitoring plan. A full DSMB is not needed. These 
individuals will review the annual summary of adverse events. In addition, they will review all 
reports of a Serious Adverse Event, or an Unexpected Adverse Event. The investigators will 
follow the requirements for principle investigator reporting requirements as outlined in Section X 
of the IRB Policies and Procedures.  

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
References: 
 
1. 
Tan HL, Kheirandish-Gozal L, Gozal D. Pediatric Home Sleep Apnea Testing: Slowly 
Getting There! Chest 2015;148:1382-95. 
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Friedman M, Wilson M, Lin HC, Chang HW. Updated systematic review of tonsillectomy 
and adenoidectomy for treatment of pediatric obstructive sleep apnea/hypopnea syndrome. 
Otolaryngol Head Neck Surg 2009;140:800-8. 
3. 
Collop NA, Anderson WM, Boehlecke B, et al. Clinical guidelines for the use of 
unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. 
Portable Monitoring Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med 
2007;3:737-47. 
4. 
Marcus CL, Brooks LJ, Draper KA, et al. Diagnosis and management of childhood 
obstructive sleep apnea syndrome. Pediatrics 2012;130:576-84. 
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Marcus CL, Brooks LJ, Draper KA, et al. Diagnosis and management of childhood 
obstructive sleep apnea syndrome. Pediatrics 2012;130:e714-55. 
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Alonso-Alvarez ML, Teran-Santos J, Ordax Carbajo E, et al. Reliability of home 
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Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr 
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Combs D, Goodwin JL, Quan SF, Morgan WJ, Parthasarathy S. Modified STOP-Bang 
Tool for Stratifying Obstructive Sleep Apnea Risk in Adolescent Children. PLoS One 
2015;10:e0142242. 
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Academy of Sleep Medicine; 2015. 
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Bland JM, Altman DG. Statistical methods for assessing agreement between two 
methods of clinical measurement. Lancet 1986;1:307-10. 
 

CONFIDENTIAL: This document is the intellectual property of David Leonard, MD, Michael McLeland, PhD, and Michael 
Montana, MD, PhD. Acceptance of this document constitutes the agreement by the recipient that no unpublished information 
contained herein will be published or disclosed without prior written approval.  
Appendix A: Modified STOP-Bang Tool for Stratifying OSA in Children 
Modified from Combs (2015)8 
 
1) SNORING: How often does your child snore loudly? Don’t know, never, rarely, 
occasionally, frequently, or almost always.  
 
2) TIRED: Is your child sleepy during the daytime? Don’t know, never, rarely, 
occasionally, frequently, or almost always. 
 
3) OBSERVED APNEA: Does your child stop breathing during sleep? Don’t know, never, 
rarely, occasionally, frequently, or almost always. 
 
4) BLOOD PRESSURE: Systolic or diastolic blood pressure greater than or equal to 95th 
percentile for height and age? Yes or No? 
 
5) BODY MASS INDEX: Greater than 95th percentile for age? Yes or No? 
 
6) ACADEMIC PROBLEMS: Does your child have learning problems? Don’t know, never, 
rarely, occasionally, frequently, or almost always. 
 
7) NECK SIZE: Is your child’s neck circumference greater than the 95th percentile for age? 
Yes or No? 
 
8) GENDER: Is your child’s Gender Male? Yes or No? 
 
 
Answers with choice that include don’t know, never, rarely, occasionally, frequently, or almost 
always are collapsed into a positive or negative response in the following manner:  
 
1) Frequently or almost always is considered a positive response. 
2) Don’t know, never, rarely, or occasionally are considered a negative response. 
 
.