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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Kristen Archbold, University of Arizona
ClinicalTrials.gov Identifier:
NCT01156649
First received: July 1, 2010
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
Device: PAP therapy
Device: Sham PAP therapy
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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.
Other Names:
  • CPAP
  • APAP
  • Continuous positive airway pressure therapy
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.
Other Names:
  • CPAP
  • APAP
  • Continuous positive airway pressure therapy

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156649

Contacts
Contact: Michelle Wences, MBA (520) 626-4627 mwences@nursing.arizona.edu

Locations
United States, Arizona
Sleep Diagnostics Center at Tucson Medical Center Recruiting
Tucson, Arizona, United States, 85715
Contact: Michelle Wences, B.S.    520-626-4627    mwences@nursing.arizona.edu   
Principal Investigator: Kristen H Archbold, RN, PhD         
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Kristen H Archbold, RN, PhD University of Arizona College of Nursing
  More Information

No publications provided

Responsible Party: Kristen Archbold, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT01156649     History of Changes
Other Study ID Numbers: HL102151
Study First Received: July 1, 2010
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Obstructive sleep apnea
neurocognitive function
cognition
pediatrics
children
continuous positive airway pressure therapy
sham treatment
randomized clinical trial
behavior
treatment

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 18, 2014