Comparing home sleep apnea testing to in-lab testing in children
Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
NA · Children's Hospital of Philadelphia · NCT05382754
This study is testing whether home sleep apnea tests are just as good as in-lab tests for diagnosing sleep apnea in children.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 317 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05382754 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-12 years who have been referred for diagnostic PSG for suspected obstructive sleep apnea.
Not a fit: Patients who have had a PSG within the last three years or have specific medical conditions such as Down syndrome or require supplemental oxygen during sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and cost-effective method for diagnosing obstructive sleep apnea in children.
How similar studies have performed: While home sleep apnea testing has been accepted for adults, this study is novel as it specifically addresses its application in the pediatric population, where evidence is currently lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Obstructive, Sleep Disorder, Sleep Apnea Syndromes, Sleep Disturbance, obstructive sleep apnea, home sleep apnea testing