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

NCT01156649 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2016-11-04

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Kristen H Archbold, PhD, RN · University of Tennessee Health Science Center College of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2016-09-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01156649 on ClinicalTrials.gov