Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA) (OSA)
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|ClinicalTrials.gov Identifier: NCT01156649|
Recruitment Status : Active, not recruiting
First Posted : July 5, 2010
Last Update Posted : November 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: PAP therapy Device: Sham PAP therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Neurobehavioral Effects of Positive Airway Pressure (PAP) Therapy in Children With Obstructive Sleep Apnea|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||November 2016|
Sham Comparator: Sham PAP therapy
Sham PAP will be used with 30 children, and consists of continuous sub-therapeutic levels of air pressure (approximately 1 cm of water) that are delivered through the nasal interface device.
Device: Sham PAP therapy
During sleep, the sham PAP device will administer a constant pressure of subtherapeutic air (approximately 1 cm of water) through a custom fit nasal interface chosen for the child's maximum comfort.
Active Comparator: Treatment group
30 children will receive active treatment PAP, which consists of automatically adjusted air pressures that are delivered through the nasal interface device at levels which effectively treats the obstructive events.
Device: PAP therapy
Nightly use of automatic positive airway pressure delivered at therapeutic levels and to be delivered through a nasal interface device selected to maximize comfort for each child.
- Neurobehavioral and cognitive function [ Time Frame: 6-12 months ]a battery of tests designed to measure: academic achievement, reaction time, attention, working memory, executive function, decision making and mental flexibility, and fine motor speed and coordination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156649
|United States, Tennessee|
|LeBonheur Pediatric and Adolescent Sleep Disorders Center|
|Memphis, Tennessee, United States, 38103|
|Principal Investigator:||Kristen H Archbold, PhD, RN||University of Tennessee Health Science Center College of Nursing|