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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Home Apnea Testing in CHildren Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Christopher M Cielo, DO · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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).