Sleep Duration, Sleep Timing, and Sleep Disordered Breathing-Associations With Obesity and Gestational Diabetes in Pregnancy.
Francesca Facco
https://pubmed.ncbi.nlm.nih.gov/33481418Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID03487185
A Randomized Trial of 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
N/A
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
Researchers are evaluating whether treating obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) during pregnancy can reduce the rate of hypertensive disorders in pregnant women. This trial focuses on women diagnosed with mild to moderate OSA between 14 weeks 0 days and 21 weeks 6 days of gestation. The study aims to fill the gap in knowledge about whether managing OSA during pregnancy improves maternal and neonatal outcomes. Participants are randomly assigned to one of two groups: one group receives autotitrating CPAP therapy with weekly contact, incentives to encourage use, and initial sleep advice counseling, while the other group receives only initial sleep advice counseling. The CPAP device is used during sleep, and the study includes ongoing support to promote adherence. Treatment continues through pregnancy, with outcomes assessed up to 14 days postpartum. During the study, women will have various assessments including monitoring for hypertensive disorders, gestational diabetes, preterm birth, cesarean delivery, and maternal cardiovascular health. Neonatal outcomes such as birth weight, respiratory support needs, and complications within 72 hours after delivery are also tracked. The study includes safety monitoring through 6 weeks postpartum and collects detailed health data to evaluate the effects of CPAP treatment during pregnancy.
CONDITIONS
Brief Title
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant women with a single baby (singleton gestation)
- Gestational age between 14 weeks 0 days and 21 weeks 6 days at randomization
- Diagnosed with mild to moderate obstructive sleep apnea (AHI score between 5 and less than 30)
You will not qualify if you...
- Current or planned treatment for sleep apnea
- Age younger than 18 years
- Unable to sleep in a stable place with CPAP access 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
- Chronic medical conditions needing oxygen therapy (e.g., pulmonary fibrosis, pulmonary hypertension, cystic fibrosis)
- Chronic kidney disease with serum creatinine over 1.3 mg/dL
- Antiphospholipid antibody syndrome
- Active liver disease or thrombocytopenia with platelet count under 100,000
- Active vaginal bleeding more than spotting at randomization
- Known chromosomal, genetic, major malformations, fetal demise, or planned pregnancy termination
- Known major uterine malformations linked to adverse outcomes
- Current use of opiates or active drug/alcohol use or unstable psychiatric condition
- Participation in other interventional studies affecting pregnancy outcomes
- Prenatal care or delivery planned outside network centers without complete 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
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From randomization between 14 weeks 0 days and 21 weeks 6 days gestation until delivery
Participants diagnosed with obstructive sleep apnea receive either continuous positive airway pressure (CPAP) therapy with weekly contact and sleep advice counseling or sleep advice counseling alone during pregnancy.
Weekly visits or contacts during treatment
Follow-up
Duration - Up to 6 weeks postpartum
Participants are monitored for maternal and neonatal outcomes up to 14 days postpartum and maternal health outcomes up to 6 weeks postpartum.
Visits up to 6 weeks postpartum
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
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Research Team
R
Rebecca Clifton, PhD
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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