A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
• Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
• Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and \<30.
Locations
United States
Alabama
University of Alabama - Birmingham
RECRUITING
Birmingham
California
Regents of the University of California San Francisco
RECRUITING
San Francisco
Illinois
Northwestern University
RECRUITING
Chicago
North Carolina
University of North Carolina - Chapel Hill
RECRUITING
Chapel Hill
New York
Columbia University
RECRUITING
New York
Ohio
Case Western Reserve-Metro Health
RECRUITING
Cleveland
Ohio State University Hospital
RECRUITING
Columbus
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Magee Women's Hospital of UPMC
RECRUITING
Pittsburgh
Rhode Island
Brown Univeristy
ACTIVE_NOT_RECRUITING
Providence
Texas
University of Texas Medical Branch
RECRUITING
Galveston
Baylor College of Medicine
RECRUITING
Houston
University of Texas - Houston
RECRUITING
Houston
Utah
University of Utah Medical Center
RECRUITING
Salt Lake City
Contact Information
Primary
Rebecca Clifton, PhD
rclifton@bsc.gwu.edu
301-881-9260
Time Frame
Start Date: 2018-08-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1500
Treatments
Experimental: Continuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
Other: Sleep Advice Control
Initial sleep advice counseling alone
Authors
Michael W Varner, Jennifer Bailit, Dwight J Rouse, William Grobman, Mark Landon, Ronald Wapner, George R Saade, Suneet Chauhan, Cynthia Gyamfi-Bannerman, Edward Chien
Related Therapeutic Areas
Sponsors
Leads: The George Washington University Biostatistics Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)