Comparing home sleep apnea testing to in-lab testing in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of home sleep apnea testing (HSAT) compared to the traditional in-lab polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA) in children. The study will assess the accuracy of both testing methods, the impact on therapeutic decision-making, and the acceptability of HSAT from the perspectives of both parents and children. Participants will be randomly assigned to undergo either HSAT or PSG first, followed by the alternate test within a week. The trial aims to provide insights into whether HSAT can be a viable alternative to PSG in pediatric patients.

Why it matters

Who can join: the full rules

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

Where it's running

• The Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Christopher M Cielo, DO — Children's Hospital of Philadelphia
• Study coordinator: Christopher M Cielo, DO
• Email: cieloc@chop.edu
• Phone: 2674265748

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.