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

NCT01156649 | Unknown Phase 1 DMC

• 1 other identifier: 14-03572FB HL102151
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; neurocognitive function; cognition; pediatrics; children; continuous positive airway pressure therapy; sham treatment; randomized clinical trial; behavior; treatment

Outcome Measures

Primary Outcomes (1)

• Neurobehavioral and cognitive function

  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.

  6-12 months

Study Arms (2)

Sham PAP therapy

SHAM COMPARATOR

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

Treatment group

ACTIVE COMPARATOR

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

Interventions

PAP therapy DEVICE

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.

Also known as: CPAP, APAP, Continuous positive airway pressure therapy

Treatment group

Sham PAP therapy DEVICE

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.

Also known as: CPAP, APAP, Continuous positive airway pressure therapy

Sham PAP therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

LeBonheur Pediatric and Adolescent Sleep Disorders Center

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Behavior

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kristen H Archbold, PhD, RN

  University of Tennessee Health Science Center College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 5, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)