RecruitingNot Applicable

Home Apnea Testing in CHildren Trial

United States317 participantsStarted 2023-03-29

Plain-language 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.

Who can participate

Age range5 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of participants with diagnosis of OSA on both HSAT and PSG

Timeframe: 2 weeks

Trial details

NCT IDNCT05382754

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Christopher M Cielo, DO

2674265748 cieloc@chop.edu

View on ClinicalTrials.gov More Sleep Apnea, Obstructive trials