Home Apnea Testing in CHildren Trial

Not Applicable

Recruiting

• Conditions: Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea Syndromes; Sleep Disturbance
• Interventions: Diagnostic Test: Home sleep apnea test; Diagnostic Test: In-lab polysomnography

• Registration Number: NCT05382754
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Study Start: 2023-03-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-12
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 317

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 without Down syndrome who have had a PSG within 3 years of enrollment
• Children with Down syndrome who have had a PSG within 1 year 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HSAT first	Home sleep apnea test	Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
PSG first	In-lab polysomnography	Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with diagnosis of OSA on both HSAT and PSG	2 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Association between therapeutic decision from HSAT compared to PSG	2 weeks	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.
Proportion of participants who prefer HSAT to PSG	2 weeks	Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG	2 weeks	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).

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States