Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
Conditions: Sleep Apnea, Obstructive
Sponsor: ResMed

Validation of ApneaLink Air home sleep testing in the diagnosis of obstructive sleep apnea in adolescent children 
NCT03748771
October 16, 2017

UCSD Human Research Protections Program 
RCHSD Only--New Biomedical Application 
RESEARCH PLAN INSTRUCTIONS 
Instructions for completing the Research Plan are available on the HRPP website. 
The headings on this set of instructions correspond to the headings of the Research Plan. 
General Instructions: Enter a response for all topic headings. 
Enter “Not Applicable” rather than leaving an item blank if the item does not apply to this project. 
1.
PROJECT TITLE
Validation of ApneaLink Air home sleep testing in the diagnosis of Obstructive Sleep Apnea in Adolescent 
Children 
2.
PRINCIPAL INVESTIGATOR
Rakesh Bhattacharjee, MD - Pediatrics 
3.
FACILITIES
Rady Children’s Hospital – Sleep Laboratory 
4.
ESTIMATED DURATION OF THE STUDY
1 year 
5.
LAY LANGUAGE SUMMARY OR SYNOPSIS (no more than one paragraph)
Obstructive sleep apnea (OSA) is highly prevalent in children affecting 2-3% of children and up to 10% of 
obese children. The reported prevalence is likely underestimated due to the lack of available laboratory 
polysomnography (PSG) testing for children. The high prevalence of OSA coupled with an increase in obesity, 
a major risk factor of OSA in children, has resulted in a significant strain for in laboratory PSG including 
children in the greater San Diego county. Currently, home sleep testing (HST) in children is restricted based on 
the limited availability of HST devices on children that have attained clearance by the US Food and Drug 
Administration (FDA). In this study, we will assess the feasibility and the validity of the ApneaLink Air HST 
device in children over the age of 12. The ApneaLink Air HST device is cleared for the diagnosis of OSA in 
adults and is frequently used amongst adult sleep medicine physicians. We will recruit twenty children over the 
age of 12 who will have their clinically indicated in laboratory PSG performed at Rady Children’s Hospital. We 
will concurrent to their in-laboratory PSG have their sleep assessed using the ApneaLink Air device. Ten 
children will repeat the ApneaLink Air HST at home following their sleep study within one week, and the 
remaining ten children will in fact have their ApneaLink Air HST performed within one week prior to their in 
laboratory clinically indicated PSG.  
6.
SPECIFIC AIMS
1. To determine validity, feasibility, and accuracy of HST as a diagnostic tool for assessing children over the
age of 12 for diagnosing OSA in children with symptoms compatible with OSA
2. To assess patient satisfaction with HST compared to in laboratory PSG in the diagnostic work up for
pediatric OSA.
7.
BACKGROUND AND SIGNIFICANCE
      Obstructive sleep apnea (OSA) is a serious, common, and under diagnosed disorder that challenges 
healthcare resources. The typical presenting feature of OSA in children is snoring. The prevalence of snoring in 
children ranges from 3-12%1 but the exact prevalence of OSA in children using an overnight in laboratory PSG 
is about 2-3%.  OSA is associated with numerous adverse health outcome issues such as behavioral, 
neurocognitive, and cardiovascular, metabolic complications as well as overall decreased quality of life. 
Behavioral issues include depression,2 behavior problems, aggression,3 excessive daytime sleepiness,4 and 
anxiety.5 Neurocognitive issues include decreased IQ,6 poor school performance,7 decreased executive function, 
8 learning difficulties, decreased information processing, decreased memory, poor visuo-spatial skills,9 
language, verbal skills, and attention deficits.6 Cardiovascular complications range from endothelial 
dysfunction10 systemic hypertension11 to pulmonary hypertension secondary to recurrent hypoxia and 
hypercapnia leading to cor-pulmonale.12 Asymptomatic degrees of pulmonary hypertension have been reported 
in up to 40% of pediatric patients with OSA.13 

 
 
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Comparing to the gold standard of in-laboratory PSG, other methods of diagnosing OSA including by history, 
physical examination, radiological studies, assessment of snoring and ambulatory PSG including home 
oximetry have reasonable specificity but limited sensitivity (high false negative rate)1. When in laboratory PSG 
is not available, clinicians are recommended to utilize these alternative approaches.  
 
Notwithstanding, given the increased awareness of the complications related to Pediatric OSA more children 
are screened for OSA and undergo some form of diagnostic evaluation. While in-laboratory PSG remains the 
gold standard for diagnosing OSA in children, the dearth of Pediatric sleep labs and Pediatric sleep specialists 
has rendered it challenging to adequately diagnose children referred for symptoms suggestive of OSA. In 
addition to limited availability of in laboratory pediatric PSG which is also observed in the greater San Diego 
county, there is a high resource burden associated with obtaining an in laboratory PSG1 as it requires 
specialized personnel, equipment, laboratory space, and the need for a child and at least one caretaker to spend 
the night outside the comfort of their homes.   
 
HST is considered as a valid alternative to adults with OSA symptoms as it is more cost effective, convenient, 
and accessible.  As a result HST has become the standard of care in adult sleep medicine14 HST devices vary in 
the number of parameters that are typically recorded and hence there is variation in the sensitivity and 
specificity of HST devices when compared to the gold standard in diagnosing adult OSA.  
 
Applicability of HST in children is rather limited as many children are intolerant to specific devices including 
the nasal cannula resulting in data collection that is lower quality or unacceptable altogether. Certainly, this 
limited tolerance is anticipated more often in younger children. Despite this preliminary studies have been 
encouraging. Brockman et al demonstrated a 93% success rate of HST conducted in children with an average 
age of 2.8 years of age and found no difference in success rates between in laboratory PSG and HST.15 A recent 
systematic review corroborated the above conclusions and revealed a sensitivity of 76%, a specificity of 77%, 
and an area under the curve of 0.88 which attested to the fact that unattended HST perform well for predicting 
pediatric OSA.16 However, further studies enabling head-to-head comparisons and validation of specific 
clinical algorithms are needed. The inability to determine total sleep time absence of EEG testing and 
subsequent inability to score respiratory events that culminate in arousal as opposed to desaturation and finally 
inability to identify sleep architecture17 can culminate the utility of HST particularly in young children. While 
these issues may be more problematic in young children, HST may be more useful in adolescents with OSA as 
OSA during adolescence parallels what is observed in adults17 
8. 
PROGRESS REPORT 
N/A  
9. 
RESEARCH DESIGN AND METHODS 
Target Population:  
Twenty nonsyndromic children over the age of 12 who will be undergoing a clinically indicated in laboratory 
PSG to rule out OSA will be approached for recruitment. In laboratory PSG testing is performed at Rady 
Children’s hospital. In addition to children with syndromes or congenital disease, children with craniofacial 
abnormalities, congenital heart disease, and pulmonary hypertension will be excluded. Demographic data 
including age, race, sex, and obesity status will be collected.  
Experimental procedure:  
Of the twenty children recruited, ten will undergo home sleep testing (HST) no greater than one week prior to 
their in-laboratory PSG, while the other ten children will undergo HST no greater than one week following 
their in laboratory PSG. Participants who are randomized to receive the HST prior to their in-laboratory PSG 
will have the Resmed ApneaLink Air mailed to their home address. This will avoid the additional need for a 
study visit. All twenty children will also undergo their HST concurrent to their in-laboratory PSG. The rational 
for splitting children in these two groups is to equally distribute the effects of the first night evenly, in which 

 
 
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the sleep architecture including reduced total REM sleep time can vary in some children during their first ever 
sleep study. As the HST will be compared to the in-lab PSG, we would like to evenly distribute this effect by 
having two groups of ten children.  
 
Upon obtaining consent by the PI, Dr. Rakesh Bhattacharjee, or the research coordinator, Janelle Celso, the 
subject will be provided with a verbal explanation and instructions on how to use the device These instructions 
(both Spanish and English version) will also be included with the device they will take home at the time of their 
sleep lab appointment.  Information about how to apply the ApneaLink Air device at home will be 
demonstrated by sleep technologists who are members of the research team. A hotline number will be provided 
to the patients and parents in order answer questions or problem solve. 
 
For home sleep testing (HST), the participants will use the Resmed ApneaLink AirTM device (Resmed, San 
Diego, USA). The ApneaLink Air is a device used to assess for sleep-disordered breathing. ApneaLink Air 
records five channels of information: respiratory effort, pulse and pulse oxygen saturation, nasal flow, body 
position and snoring. It includes a chest belt, nasal cannula, oximeter and recording device. This device is 
approved by the FDA for use in diagnosing OSA in adults. This device is not yet approved for use in the 
proposed subject population (12-17 years old) and the data obtained from this study may be used for the 
application of an FDA approval for children over 12. No clinical interventions will be implemented based on 
the results of the home sleep test. 
 
This device is a non-significant risk device as it poses minimal risk or clinical harm to the pediatric population. 
The following criteria for a device to be deemed non-significant risk are met:   
1. The device is NOT intended as an implant that presents a potential for serious risk to health, safety, or 
welfare of a subject 
2. The device is NOT purported or represented to be  for a use in supporting or sustaining human life that 
presents a potential for serious risk to the health, safety, or welfare of a subject 
3. The device is NOT for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health that presents a potential for serious risk to 
the health, safety, or welfare of a subject 
4. The device does NO otherwise present a potential for serious risk to the health, safety, welfare of a 
subject. 
Furthermore, adolescents with suspected OSA (the study population) tend to parallel the OSA presentation of 
adults. Thus, no additional risk, other than those for adults, will incur to the patient if the device is used by the 
study population.  
 
As stated, all subjects will have ApneaLink Air performed twice, once at home, and once during the sleep 
study. All of the components of the ApneaLink Air device will be placed in addition to the equipment used in 
the sleep lab. With exception to the nasal cannula, this should not interfere or result in additional discomfort to 
the in-lab sleep study. With regards to the nasal cannula, a ‘splitter’ will be used in which one nasal cannula 
will provide information on flow to both the ApneaLink Air device as well as the in-laboratory lab equipment 
(Nihon Koden, Irvine CA) 
 
For ApneaLink Air testing performed at home, these subjects will receive a shipping box and return label to 
return the device following completion.  
 
All children undergoing sleep study testing will have routine clinical surveys be performed. Some of this 
information will be gathered for research purposes to assess the pre-test probability of OSA. Following the 
home sleep test and in lab sleep test, all children will be interviewed by the research coordinator and asked 
questions concerning the child’s experiences and comparing the two environments for their sleep test via a 

 
 
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telephone follow-up.   
 
 
Data Analysis:  
Descriptive statistics will be used to summarize the children’s demographic and polysomnographic 
characteristics. Comparisons between in laboratory sleep study and HST will be conducted using Mann 
Whitney U-Test for not-normal data, and Student’s t-test for normally distributed variables. Factors that may 
have influenced the interpretability of the recordings will be investigated using logistic regression. Age, gender, 
AHI, and BMI z- scores will be analyzed as independent variables in the logistic regression equation. Odds 
ratios and their 95% confidence intervals (95% CI) will be calculated. A p-value <0.05 will be considered 
statistically significant. Any information that will be sent to the sponsor will be de-identified. 
 
The criteria for an unfeasible HST or HST failure will be defined as:  
1. Loss of the nasal flow channel, or thoracic or abdominal sensor 
2. Recordings with less than 4h of artifact-free recording time 
3. Less than 4h of Sp02 signal 
 
All studies will be scored by a trained sleep technician, and interpreted by Dr. Rakesh Bhattacharjee, in order to 
avoid variability. Both sleep scoring and sleep interpretations will be blinded from the findings of HST 
performed at home and in the sleep lab.  
 
In the event that the HST is deemed not valid or inadequate when compared to the in laboratory PSG, the 
subject will remain in the study and will use this data to evaluate validity and feasibility of HST. Information  
 
10. HUMAN SUBJECTS 
Human subjects will be pediatric patients between the ages of 12-17, receiving a sleep study at Rady Children’s 
Hospital as ordered by Dr. Rakesh Bhattacharjee to rule out OSA.  
 
Inclusion criteria: 
• Patients presenting with symptoms of OSA needing a sleep study 
• Patients between the ages of 12 and less than 18 years  
Exclusion criteria:  
• Patients less than 12 years old and greater than 18 years old 
• Children with syndromes or congenital disease including Down Syndrome, Prader-Willi syndrome, 
children with craniofacial disorders, and finally children with congenital heart disease or pulmonary 
hypertension 
 
Pregnant women are not eligible to participate in the study as they have clinical parameters that would be 
different from the current study population. Children with cognitive impairment will also be excluded.  
 
The research is not greater than minimal risk and thus falls under section 404 of 45 CFP 46 Subpart D. 
 
11. RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
The research coordinator and PI will screen the PI’s schedule and sleep lab schedule for potential subjects and 
approach them during their clinic visit or in the case for upcoming sleep studies will be approached over the 
phone. For cases that meet eligibility, the PHI that will be reviewed would be: patient name, parent name, 
phone number, medical record number, patient demographics (age, sex), clinical characteristics (diagnosis), and 
those undergoing sleep study for possible OSA.  Once identified, data will be coded with a unique study 

 
 
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number. We are seeking a partial HIPAA waiver as the study poses minimal risk and subject recruitment cannot 
be feasibly complete without a HIPAA waiver. Documentation of waiver has been uploaded along with the 
research plan.  
 
We will apply for a waiver of consent and HIPAA authorization to review PHI for subject eligibility. Loss of 
confidentiality is the only risk and we will take measures to minimize this. The study will not adversely affect 
the rights and welfare of the subjects, and could not feasibly be done without a waiver of consent or a HIPAA 
authorization. 
a. The research is minimal risk: the study poses minimal risk: The only risk with the retrospective portion 
of this study is a breach of confidentiality. Section 16 discusses the steps we will take to ensure their 
privacy 
b. The waiver will not adversely affect the rights and welfare of the subjects: We do not believe that 
granting the waiver will adversely affect the privacy rights and welfare of the individuals whose records 
will be used. No experimental procedures will be performed during this review. All possible methods to 
ensure confidentiality will be employed with the collection of chart data including (de-identification). 
Thus, any increase to the risk of confidentiality violation is very minimal and not at all anticipated. 
c. The research could not practicably be carried out without the waiver: The HIPPA opt-out waiver will 
only be used to collect information from the medical records in order to identify eligible patients.  It 
would be impractical to obtain permission and authorization from these patients because they may or 
may not be eligible for inclusion.  Once these potential participants are identified and meet inclusion 
criteria, they will be consented to be included in the study. 
d. As soon as the patient characteristics are identified, the PHI originally used to extract the data will be 
destroyed from the hard drive.  
e. Whenever appropriate, the subjects will be provided with additional pertinent information after 
participations. Because all PHI will be destroyed at the completion of this study, it will not be possible to 
provide information after participation.  
f. The study investigators will not re-use or disclose the PHI for any other purposes except for the research 
study outlined here.  
g. The study investigator will provide any additional pertinent information as required by the IRB 
committee. 
 
Potential participates in the clinic will then be approached for study recruitment after the decision for a sleep 
study has been made. Dr. Bhattacharjee will approach the subjects to present research opportunities at the end 
of a clinical appointment. Only patients undergoing a sleep study for OSA who agree to participate in this 
research study will be offered to complete HST using ResMed’s ApneaLink™.   
 
Children who are already scheduled for a sleep study to rule out obstructive sleep apnea in the sleep lab will 
also be approached over the phone if they meet inclusion criteria.  Briefly, parents will be informed about study 
procedures and study risks over the phone (see phone script). For subjects ages 12 to less than 18, we will 
simply read the approved appropriate assent forms. There will be no phone script sent to the IRB for this 
matter. If parents and subjects are agreeable over the phone we will obtain verbal consent over the phone and 
either mail or email them copies of the consent form to sign or have the families sign the consent form in the 
sleep lab.   
 
12. INFORMED CONSENT 
Consent will be obtained in sleep clinic or sleep lab, in a private room, using a standard consent/assent form for 
adolescent participants and additional consent/assent forms for parental consent. In the clinic, consent will be 
obtained by clinical study staff or research coordinator. In the sleep lab, consent will be obtained by research 

 
 
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coordinators. All members of the research team have the necessary training to obtain consent.  A code is 
assigned to each participant (random/alphanumeric). This code will be associated with the subject for the 
duration of the study.  
 
We will identify minors from age obtained through clinical data.  We will not accept subjects into the study 
who do not supply their age. 
13. ALTERNATIVES TO STUDY PARTICIPATION 
The study is entirely voluntary and the only alternative is not to participate.  Not participating will confer no 
disadvantage to the participant. 
14. POTENTIAL RISKS 
With regards to HST, there are some minor discomforts associated with the set up and monitoring which 
include: developing redness, irritation, or a rash that might signal and allergic reaction. Furthermore, if the 
cannula is worn incorrectly, there appears to be a risk related to strangulation. The risks of home sleep studies 
are minimal and similar to risk encountered with an in-lab sleep study as mentioned in section 12. Further, steps 
will be taken to provide adequate education to subjects and parents prior to using HST at home. 
There is a small potential risk of loss of confidentiality. Efforts described in section 15 will be taken in order to 
prevent this loss. 
15. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
Patient confidentiality will be protected by assignment of a unique study number to all samples. No publication  
or written reports will link patient data with a name. Entry into the computer data files will require a password.  
The patient’s full name will not be entered into the file but a log sheet with the study number and name will be 
kept in the PI’s office in a locked file cabinet. The patient's full name is also logged into the RCHSD data base 
as required for all research subjects at RCHSD. Access to this database is password protected. 
16. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND 
MANAGEMENT 
There is always the risk of subject information being released accidentally.  We will make every effort to 
maintain patient privacy and confidentiality both during and following the study. Electronic study data will be 
de-identified by substitution of codes for names and hospital identifiers and will be stored on a secure disk for 
access by Investigator and study staff only and any hard copies will be stored in a locked cabinet. In all 
correspondence and in internal study reports that require identification of individual subjects, subjects will be 
referred to and known by their ID number and character name code.  All subject data forms (CRF’s) will only 
list the ID number. All research staff are CITI certified and have had impressed upon them the importance of 
confidentiality. This study does not involve the collection of sensitive personal information from subjects. Data 
will be stored only at UCSD sites and its use will be confined to that specified in this protocol and its approved 
amendments. 
Data generated as a result of this study will only be made available for inspection upon request of the UCSD 
Human Research Protection Program. 
17. POTENTIAL BENEFITS 
There are no direct benefits to patients included in the study however there is great benefit to clinicians, patients 
and the scientific community. Children with symptoms of OSA endure long wait times to undergo diagnostic 
testing and sleep apnea. Researchers and clinicians could also use this study to determine the feasibility of HST 
in the context of diagnosing OSA which could reduce wait times but also improve the comfort for older 
children by having testing conducted in their own home. 
18. RISK/BENEFIT RATIO 
This project is categorized as a "minimal risk/no direct benefit" study: 45 CFR 46.404. The potential benefit to  
children with OSA is to validate the use of HST in diagnosing OSA in older children to be able to be used more 

 
 
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broadly in the clinical arena.  
19. EXPENSE TO PARTICIPANT 
None 
20. COMPENSATION FOR PARTICIPATION 
For participation in our study, the patients will be incentivized with a 100-dollar gift card to Amazon.com. The 
subject will receive $50.00 for each HST completed for a total of $100.00 after 2 HST studies. 
 
21. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES 
Rady Children’s Sleep Lab 
• Rakesh Bhattacharjee, MD (PI) has privileges at Rady Children’s Hospital. He will be responsible for 
recruitment, consenting and answering questions with the study subjects, data analysis, interpretation of 
study results, and will be involved in subject recruitment in the sleep clinic. He has experience in all 
aspects of the proposed research.  
• Janelle Celso B.S. is the Research Coordinator – She will be responsible for IRB modifications, 
recruitment, consenting, data collection and data analysis. She has all the training needed for her role. 
• Gretchen Dever B.S., RRT-SDS – She will be responsible for IRB modifications, recruitment, consenting, 
data analysis, education of parents/subjects to applying the ApneaLink Air device for a sleep recording 
and assigning devices for each subject. She has all the training needed for her role. 
• Alicia Poncy RPSGT - She will be responsible for recruitment, consenting, education of parents/subjects 
to applying the ApneaLink Air device for a sleep recording data collection and interpretation of study 
results. She has all the training needed for her role. 
• Angela Rizzuto-RRT-SDS- She will be responsible for recruitment, consenting, data collection, education 
of parents/subjects to applying the ApneaLink Air device for a sleep recording and interpretation of study 
results. She has all the training needed for her role. 
22. BIBLIOGRAPHY 
References Cited: 
1. Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schecheter MS, Sheldon SH, Spruyt K, Ward SD,          
Lehmann C, Shiffman RN: American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea 
syndrome. Pediatrics. 2012 Sep;130(3):576-84. 
2.           Galland BC, Dawes PJ, Tripp EG, Taylor BJ. Changes in behavior and attentional capacity after adenotonsillectomy. 
Pediatric research 2006; 59:711-716. 
3. 
Chervin RD, Dillon JE, Archbold KH, Ruzicka DL. Conduct problems and symptoms of sleep disorders in children. Journal 
of the American Academy of Child and Adolescent Psychiatry 2003; 42:201-208. 
4. 
Goodwin JL, Babar SI, Kaemingk KLet al. Symptoms related to sleep-disordered breathing in white and Hispanic children: 
the Tucson Children's Assessment of Sleep Apnea Study. Chest 2003; 124:196-203. 
5. 
O'Brien LM, Mervis CB, Holbrook CRet al. Neurobehavioral implications of habitual snoring in children. Pediatrics 2004; 
114:44-49. 
6. 
Chervin RD, Ruzicka DL, Giordani BJet al. Sleep-disordered breathing, behavior, and cognition in children before and after 
adenotonsillectomy. Pediatrics 2006; 117:e769-778. 
7. 
Chervin RD, Clarke DF, Huffman JLet al. School performance, race, and other correlates of sleep-disordered breathing in 
children. Sleep medicine 2003; 4:21-27. 
8. 
Kohler MJ, Lushington K, van den Heuvel CJ, Martin J, Pamula Y, Kennedy D. Adenotonsillectomy and neurocognitive 
deficits in children with Sleep Disordered Breathing. PloS one 2009; 4:e7343. 
9. 
Spruyt K, Capdevila OS, Kheirandish-Gozal L, Gozal D. Inefficient or insufficient encoding as potential primary deficit in 
neurodevelopmental performance among children with OSA. Developmental neuropsychology 2009; 34:601-614. 
10. 
Bhattacharjee R, Kim J, Alotaibi WH, Kheirandish-Gozal L, Capdevila OS, Gozal D. Edothelial dysfunction in children 
without hypertension: potential contributions of obesity and obstructive sleep apnea. Chest. 2012 Mar; 141 (3): 682-691. 
11.          Kwok KL, Ng DK, Cheung YF. BP and arterial distensibility in children with primary snoring. Chest 2003; 123:1561-1566. 
12. 
Duman D, Naiboglu B, Esen HS, Toros SZ, Demirtunc R. Impaired right ventricular function in adenotonsillar hypertrophy. 
The international journal of cardiovascular imaging 2008; 24:261-267. 
13. 
Tal A, Leiberman A, Margulis G, Sofer S. Ventricular dysfunction in children with obstructive sleep apnea: radionuclide 
assessment. Pediatric pulmonology 1988; 4:139-143. 

 
 
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14. 
Trikalinos TA, Ip S, Raman Get al. AHRQ Technology Assessments Home Diagnosis of Obstructive Sleep Apnea-Hypopnea 
Syndrome. Rockville (MD): Agency for Healthcare Research and Quality (US), 2007. 
15. 
Brockmann PE, Perez JL, Moya A. Feasibility of unattended home polysomnography in children with sleep-disordered 
breathing. International journal of pediatric otorhinolaryngology 2013; 77:1960-1964. 
16. 
Certal V, Camacho M, Winck JC, Capasso R, Azevedo I, Costa-Pereira A. Unattended sleep studies in pediatric OSA: a 
systematic review and meta-analysis. The Laryngoscope 2015; 125:255-262. 
17.         Tan HL, Kheirandish-Gozal L, Gozal D. Pediatric Home Sleep Apnea Testing: Slowly Getting There! Chest. 2015 Dec; 148 
(6): 1382-95 
18.         Tapia IE, Karamessinis L, Bandla P, Huang J, Kelly A, Pepe M, Schultz B. Gallagher P, Brooks LJ, Marcus CL. 
Polysomnographic values in children undergoing puberty: Pediatrics vs. adult respiratory rules in adolescents. Sleep. 2008 
Dec; 31(12): 1737-44 
23. FUNDING SUPPORT FOR THIS STUDY 
Pending industry sponsored funding from ResMed Inc. 
24. BIOLOGICAL MATERIALS TRANSFER AGREEMENT 
N/A 
25. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER 
N/A 
26. IMPACT ON NURSING STAFF 
There is no anticipated impact on nursing or ancillary staff.  
There is no anticipated impact on nursing or ancillary staff.  
The investigators and study staff have no relevant conflicts of interest for this study. 
28. OTHER APPROVALS/REGULATED MATERIALS 
N/A 
29. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY 
ASSESSMENT 
N/A   
Version date: 3/17/14