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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 5Years - 12Years
All Genders
ID05382754

Comparing Home Sleep Apnea Testing and In-Lab Polysomnography to Diagnose Obstructive Sleep Apnea in Children Ages 5 to 12

Led by Children's Hospital of Philadelphia · Updated on 2026-04-21

317

Participants Needed

1

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating home sleep apnea testing HSAT compared to the standard in-lab polysomnography PSG for diagnosing obstructive sleep apnea OSA in children aged 5 to 12 years. This trial aims to compare the accuracy of HSAT and PSG, how each test influences treatment decisions, and how acceptable and preferable these tests are to both children and their parents. The study is conducted because PSG, while the recommended method, is costly and not widely accessible, leading to many children undergoing treatment without a formal diagnosis. Participants will be randomly assigned to either have the HSAT before their clinical PSG or after it. Both tests will be completed within one week. The HSAT involves a level II home sleep apnea test conducted at home with parental supervision, while PSG is an overnight sleep study in a lab with continuous monitoring by clinical staff. Pediatric sleep medicine doctors will review clinical data along with either HSAT or PSG results to make treatment decisions. During the study, families will complete questionnaires about how acceptable HSAT is and which test they prefer. The primary outcome is the proportion of participants diagnosed with OSA by both HSAT and PSG within two weeks. Secondary outcomes include the agreement in treatment decisions between the two tests, participant preference for HSAT, and the correlation of apnea severity indices between HSAT and PSG. The study monitors participants closely during this short period, with all procedures completed within about two weeks.

CONDITIONS

Brief Title

Home Apnea Testing in CHildren Trial

Research Team

C

Christopher M Cielo, DO

I

Ignacio E Tapia, MD

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