NCT05516524

HSAT for OSA Management in Children

Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• 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 the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children

Detailed description

Many children have residual obstructive sleep apnea (OSA) following adenotonsillectomy, but in-lab polysomnography (PSG), the recommended means of re-evaluating these patients, is resource-intensive and availability is limited. Home sleep apnea testing (HSAT), a similar test performed in the patient's home and used clinically in adults, may offer an alternative means of evaluating the effect of OSA treatment in children and make testing more convenient and widely available.

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	PSG	Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-09-10
• Completion: 2025-09-17
• First posted: 2022-08-25
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study