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Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

NCT01554527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-01-14

Study results available
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Summary

Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.

Conditions

  • Sleep Apnea, Obstructive
  • Sleep Apnea Syndromes
  • Child Behavior Disorders
  • Attention Deficit Disorder With Hyperactivity
  • Disorders of Excessive Somnolence

Interventions

PROCEDURE

CPAP treatment

6 months of treatment with PAP (CPAP or BPAP)

OTHER

No CPAP treatment

Children randomized to the comparison group will receive routine care

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Michigan Technological University

    collaborator OTHER

  • University of Michigan

    lead OTHER

Principal Investigators

  • Ronald D. Chervin, MD, MS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-10-29
Completion
2017-10-29

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01554527 on ClinicalTrials.gov