Actively Recruiting
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Led by The George Washington University Biostatistics Center · Updated on 2026-04-06
1500
Participants Needed
14
Research Sites
438 weeks
Total Duration
On this page
Sponsors
T
The George Washington University Biostatistics Center
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton gestation with no twin pregnancy unless reduced to singleton before 14 weeks gestation
- Gestational age between 14 weeks 0 days and 21 weeks 6 days at randomization
- Diagnosed with mild to moderate obstructive sleep apnea defined by an apnea-hypopnea index score of 5 to less than 30
You will not qualify if you...
- Previously prescribed, current, or planned therapy for sleep apnea
- Age under 18 years
- Unable to sleep in a stable place with access to CPAP at least 5 nights per week
- Asthma requiring systemic steroids for more than 14 days in the past 6 months
- Current use of prescribed sleeping pills for insomnia
- Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis)
- Chronic renal disease with serum creatinine over 1.3 mg/dL
- Antiphospholipid antibody syndrome
- Active liver disease or thrombocytopenia (platelet count under 100,000)
- Active vaginal bleeding more than spotting at time of randomization
- Known chromosomal, genetic, major malformations, fetal demise, or planned pregnancy termination
- Known major uterine malformations linked to adverse pregnancy outcomes
- Current daily use of opiates (heroin, methadone, or other opioids)
- Active drug use, alcohol use, or unstable psychiatric condition
- Participation in another interventional study affecting preeclampsia, hypertensive disorders, or gestational diabetes
- Prenatal care or delivery planned at a non-network center without electronic medical record access
- Previous participation in this trial during a prior pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Regents of the University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Columbia University
New York, New York, United States, 10032
Actively Recruiting
5
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Case Western Reserve-Metro Health
Cleveland, Ohio, United States, 44109
Actively Recruiting
7
Ohio State University Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
8
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
10
Brown Univeristy
Providence, Rhode Island, United States, 02905
Active, Not Recruiting
11
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Active, Not Recruiting
12
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Texas - Houston
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
R
Rebecca Clifton, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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