Home Apnea Testing in CHildren Trial

Study Overview
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Brief Summary
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This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.

Detailed Description
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In-lab attended polysomnography (PSG) is recommended for the diagnosis of obstructive sleep apnea (OSA) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test. Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.

Official Title
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Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children

Conditions
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Sleep Apnea, Obstructive, Sleep Disorder, Sleep Apnea Syndromes, Sleep Disturbance

Intervention / Treatment
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* Diagnostic Test: Home sleep apnea test
* Diagnostic Test: In-lab polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female children age 5-12 years old inclusive Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria: Children who have had a PSG within 3 years of enrollment Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep Children with a tracheostomy or tracheocutaneous fistula Children who live in a facility without their parent

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within one week.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSAT first<br>Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography | Diagnostic Test: Home sleep apnea test<br>* Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.<br>* Other names: HSAT;|
| Active Comparator: PSG first<br>Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography. | Diagnostic Test: In-lab polysomnography<br>* Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.<br>* Other names: PSG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with diagnosis of OSA on both HSAT and PSG | Obstructive sleep apnea (OSA) defined as an obstructive apnea hypopnea index of greater than 2 events/hour on both home sleep apnea test (HSAT) and polysomnography (PSG). | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between therapeutic decision from HSAT compared to PSG | Logistic regression will compare therapeutic decision (conservative management versus active treatment) from home sleep apnea test (HSAT) or polysomnography (PSG) by investigator blinded to the result of the alternate test. | 2 weeks | 
| Proportion of participants who prefer HSAT to PSG | Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test | 2 weeks | 
| Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG | Obstructive apnea hypopnea index will be assessed as a continuous variable with polysomnography (PSG) assigned as the reference test compared to home sleep apnea test (HSAT). | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, home sleep apnea testing