Home Apnea Testing in Children Trial (NCT05382754)

This study is comparing two ways to diagnose obstructive sleep apnea (OSA) in children: a home sleep apnea test (HSAT) and an in-lab polysomnography (PSG). PSG is the standard test, but it can be expensive and hard to access. HSAT is used for adults, but more research is needed to see if it works well for children. This trial wants to see how accurate HSAT is compared to PSG, how it affects treatment decisions, and how acceptable it is to parents and children. We are looking for 317 children aged 5 to 12 years old who have been referred to Children's Hospital of Philadelphia for OSA evaluation. The study will be considered successful if a good number of participants are diagnosed with OSA by both the home test and the in-lab test.

Study design
This is an interventional study that will randomize participants to receive either a home sleep apnea test or an in-lab polysomnography first, then the other test within one week.
What's involved
You would complete two sleep tests: one at home with parental supervision and one overnight in a sleep laboratory. Families will also complete questionnaires about their experience.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, diagnosis of OSA on both tests, is measured at 2 weeks.

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NCT05382754

Home Apnea Testing in CHildren Trial

Recruiting
NAAges 5–12InterventionalDiagnostic
Children's Hospital of Philadelphia
~317 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Home sleep apnea testIn-lab polysomnography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with diagnosis of OSA on both HSAT and PSG
Measured over 2 weeks
Sleep Apnea, Obstructive
Sleep Disorder
Sleep Apnea Syndromes
Sleep Disturbance
1 sites across 1 states
Pennsylvania1
  • Christopher M Cielo, DO · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

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Eligibility criteria

Inclusion

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

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
  • Proportion of participants with diagnosis of OSA on both HSAT and PSG2 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).