NCT05382754

Home Apnea Testing in CHildren Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 317 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Apnea Syndromes
• Sleep Disturbance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Home sleep apnea test	Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
DIAGNOSTIC_TEST	In-lab polysomnography	Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.

Timeline

• Start date: 2023-03-29
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2022-05-19
• Last updated: 2025-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study