RecruitingNot ApplicableNCT03487185

Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy

A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy


Sponsor

The George Washington University Biostatistics Center

Enrollment

1,500 participants

Start Date

Aug 3, 2018

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether CPAP therapy (a breathing mask worn at night) can reduce pregnancy complications in women with mild to moderate sleep apnea during pregnancy. **You may be eligible if...** - You are pregnant with a single baby - Your pregnancy is between 14 and 22 weeks along - You have been diagnosed with mild to moderate sleep apnea (AHI score between 5 and 30) - You are 18 or older **You may NOT be eligible if...** - You are already being treated for sleep apnea - You cannot sleep in a stable place with access to a CPAP machine at least 5 nights per week - You have asthma requiring long-term steroids, or chronic conditions requiring oxygen - You have chronic kidney disease (creatinine above 1.3 mg/dL) - You have antiphospholipid antibody syndrome - You have active liver disease or certain other serious medical complications - You currently take prescription sleeping pills Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous Positive Airway Pressure

Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling

OTHERSleep Advice Control

Initial sleep advice counseling alone


Locations(14)

University of Alabama - Birmingham

Birmingham, Alabama, United States

Regents of the University of California San Francisco

San Francisco, California, United States

Northwestern University

Chicago, Illinois, United States

Columbia University

New York, New York, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Case Western Reserve-Metro Health

Cleveland, Ohio, United States

Ohio State University Hospital

Columbus, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Brown Univeristy

Providence, Rhode Island, United States

University of Texas Medical Branch

Galveston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Texas - Houston

Houston, Texas, United States

University of Utah Medical Center

Salt Lake City, Utah, United States

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NCT03487185


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