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Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA) (OSA)

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ClinicalTrials.gov Identifier: NCT01156649
Recruitment Status : Unknown
Verified May 2016 by University of Tennessee.
Recruitment status was:  Active, not recruiting
First Posted : July 5, 2010
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Tracking Information
First Submitted Date  ICMJE July 1, 2010
First Posted Date  ICMJE July 5, 2010
Last Update Posted Date November 4, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
Neurobehavioral and cognitive function [ Time Frame: baseline, 3 months and 6 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.
Change History Complete list of historical versions of study NCT01156649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
Parental Reports of Child Behavior [ Time Frame: baseline, 3 months and 6 months ]
Behavior will be measured with the following paper and pencil questionnaires to be completed by the child's parent/primary caregiver: Connors Parental Rating Scale-Revised: Long version (CPRS-R: L); the Child Behavior Checklist (CBC) and the Behavior Rating Inventory of Executive Function (BRIEF).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA)
Official Title  ICMJE Neurobehavioral Effects of Positive Airway Pressure (PAP) Therapy in Children With Obstructive Sleep Apnea
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 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.
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, 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • 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.
    Other Names:
    • CPAP
    • APAP
    • Continuous positive airway pressure therapy
  • 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.
    Other Names:
    • CPAP
    • APAP
    • Continuous positive airway pressure therapy
Study Arms  ICMJE
  • 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.
    Intervention: Device: Sham PAP therapy
  • 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.
    Intervention: Device: PAP therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 3, 2016)
79
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2010)
60
Estimated Study Completion Date  ICMJE November 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 6.0 and 11.9 years
  2. 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).
  3. English is spoken as the child's primary language.
  4. Willingness to complete study protocol if randomized into the placebo treatment group.

Exclusion Criteria:

  1. The presence of any other diagnosable sleep disorder other than OSA.
  2. Previous use of PAP therapy for sleep disordered breathing at any time in the patient's history
  3. 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).
  4. Presence of a chronic neurological disorder, chronic renal failure, diabetes, rheumatoid arthritis, or another chronic inflammatory condition. -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01156649
Other Study ID Numbers  ICMJE 14-03572FB HL102151
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Tennessee
Study Sponsor  ICMJE University of Tennessee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristen H Archbold, PhD, RN University of Tennessee Health Science Center College of Nursing
PRS Account University of Tennessee
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP