Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
Children's Hospital of Philadelphia
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.
Description
In-lab attended polysomnography (PSG) is recommended for the diagnosis of obstructive sleep apnea (OSA) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PS…
Eligibility
- Age range
- 5–12 years
- Sex
- All
- Healthy volunteers
- No
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 pr…
Interventions
- Diagnostic TestHome sleep apnea test
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
- Diagnostic TestIn-lab polysomnography
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
Location
- The Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania