Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder, Sleep Disturbance
Conditions
Keywords
obstructive sleep apnea, home sleep apnea testing
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.
Detailed 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 PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test. Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.
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.
Sponsors
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigators will be masked as to the order of the two sleep tests
Intervention model description
Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within one week.
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
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 pressure during sleep * Children with a tracheostomy or tracheocutaneous fistula * Children who live in a facility without their parent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with diagnosis of OSA on both HSAT and PSG | 2 weeks | Obstructive sleep apnea (OSA) defined as an obstructive apnea hypopnea index of greater than 2 events/hour on both home sleep apnea test (HSAT) and polysomnography (PSG). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between therapeutic decision from HSAT compared to PSG | 2 weeks | Logistic regression will compare therapeutic decision (conservative management versus active treatment) from home sleep apnea test (HSAT) or polysomnography (PSG) by investigator blinded to the result of the alternate test. |
| Proportion of participants who prefer HSAT to PSG | 2 weeks | Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test |
| Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG | 2 weeks | Obstructive apnea hypopnea index will be assessed as a continuous variable with polysomnography (PSG) assigned as the reference test compared to home sleep apnea test (HSAT). |
Countries
United States
Contacts
CONTACTChristopher M Cielo, DO
CONTACTIgnacio E Tapia, MD
PRINCIPAL_INVESTIGATORChristopher M Cielo, DO
Children's Hospital of Philadelphia
Outcome results
None listed