Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA)
Status unconfirmed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Obstructive Sleep Apnea
In brief
Obstructive sleep apnea is a problem for a large number of children and can result in problems with thinking patterns, behaviors and sleep if left untreated. Little is known about how positive airway pressure (PAP) therapy might help children who need treatment for obstructive sleep apnea. We will investigate how PAP therapy might be able to improve thinking patterns, behavior and sleep problems in children with obstructive sleep apnea.
Key facts
- Study ID
- NCT01156649
- Run by
- University of Tennessee
- People needed
- 79
- Starts
- 2010-07-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2016-11-04
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 6.0 and 11.9 years
- Nocturnal PSG (polysomnography) shows an apnea/hypopnea index of at least 1.5-10 events on average per hour of sleep and an apnea index of less than 1 per hour (mild to moderate OSA group), or, PSG shows an apnea index of 1 or greater PLUS an apnea/hypopnea index of 10.0 or greater (severe OSA group).
- English is spoken as the child's primary language.
- Willingness to complete study protocol if randomized into the placebo treatment group.
You may not qualify if…
- The presence of any other diagnosable sleep disorder other than OSA.
- Previous use of PAP therapy for sleep disordered breathing at any time in the patient's history
- Presence of health problems likely to interfere with neurocognitive test result interpretation, such as previously diagnosed psychiatric illness (i.e., attention-deficit hyperactivity disorder, depression, psychoses) or medical genetic syndromes (i.e., Prader-Willi syndrome, Fragile X).
- Presence of a chronic neurological disorder, chronic renal failure, diabetes, rheumatoid arthritis, or another chronic inflammatory condition. -
Where it is running
- LeBonheur Pediatric and Adolescent Sleep Disorders Center — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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