| NCT ID | NCT05382754 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Sleep Apnea, Obstructive |
| Study Type | INTERVENTIONAL |
| Enrollment | 317 participants |
| Start Date | 2023-03-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 317 participants in total. It began in 2023-03-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Christopher M Cielo, DO
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT05382754 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Sleep Apnea, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05382754 currently recruiting?
Yes, NCT05382754 is actively recruiting participants. Contact the research team at cieloc@chop.edu for enrollment information.
Where is the NCT05382754 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05382754 clinical trial?
NCT05382754 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Christopher M Cielo, DO at Children's Hospital of Philadelphia. The trial plans to enroll 317 participants.