Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA)
Recruitment status was Recruiting
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.
Obstructive Sleep Apnea
Device: PAP therapy
Device: Sham PAP therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Neurobehavioral Effects of Positive Airway Pressure (PAP) Therapy in Children With Obstructive Sleep Apnea|
- Neurobehavioral and cognitive function [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Sham Comparator: Sham PAP therapy
Sham PAP will be used with 30 children, and consists of continuous subtherapeutic 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
Treatment PAP 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.
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, the effect of PAP therapy on neurocognitive, behavioral and sleep patterns in school-aged children with OSA is not well known. The goal of this innovative study is to conduct a randomized, double-blind, placebo controlled, trial which will determine the effects of PAP therapy on neurocognitive and behavioral patterns and sleep architecture in children with OSA. A battery of neurocognitive tests and parent behavioral rating assessments will be given to school-aged children with OSA before, after 3 months and again after 6 months of treatment with PAP therapy only; or 3 months of PAP placebo use followed by 3 months of PAP therapy. Full polysomnography and PAP titration sleep studies will be performed following a night of adaptation sleep in a sleep laboratory at all three time points. Compliance to PAP therapy will be monitored on a daily basis with a remote internet-linked communicator that is attached to the participant's PAP pressure generator. The hypothesis of this ground-breaking project is that 3 months of continuous compliance to a regimen of PAP therapy will result in significant improvement in neurocognitive and behavioral patterns and that sleep architecture will be positively changed to become more reflective of normative values for school-aged children. The results of this innovative and ground-breaking study will have far-reaching effects for sleep clinicians and other health care providers in support of the continued use of PAP therapy as a treatment for OSA and to inform the health-care community about the efficacy of PAP therapy on neurocognition and behavior patterns in school-aged children with OSA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156649
|Contact: Michelle Wences, MBA||(520) email@example.com|
|United States, Arizona|
|Sleep Diagnostics Center at Tucson Medical Center||Recruiting|
|Tucson, Arizona, United States, 85715|
|Contact: Michelle Wences, B.S. 520-626-4627 firstname.lastname@example.org|
|Principal Investigator: Kristen H Archbold, RN, PhD|
|Principal Investigator:||Kristen H Archbold, RN, PhD||University of Arizona College of Nursing|