Status:
UNKNOWN
Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA)
Lead Sponsor:
University of Tennessee
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
6-12 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
Positive airway pressure (PAP) therapy has been shown to be an effective treatment which can improve neurocognitive performance and sleep patterns in adults with obstructive sleep apnea (OSA). However...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- 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. -
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01156649
Start Date
July 1 2010
End Date
November 1 2016
Last Update
November 4 2016
Active Locations (1)
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1
LeBonheur Pediatric and Adolescent Sleep Disorders Center
Memphis, Tennessee, United States, 38103