NCT03487185 · The George Washington University Biostatistics Center
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
(SLEEP)
What this study is about
A randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Previously prescribed, current or planned therapy for sleep apnea.
- Age \< 18 years, because the rate of sleep apnea in this population is extremely low.
- Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.
- Asthma requiring systemic steroid therapy for more than 14 days within the past 6 months because this population is expected to be unresponsive to CPAP therapy.
- Current use of prescribed sleeping pills for insomnia.
- Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis) because this population is expected to be unresponsive to CPAP therapy.
- Chronic renal disease with serum creatinine \>1.3 mg/dL because the primary outcome would be pre-determined.
- Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.
- History of medical complications such as:
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
- Thrombocytopenia with platelet count \<100,000 because of the difficulty in assessing the primary outcome.
- Active vaginal bleeding (more than spotting) at the time of randomization.
- Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.
- Known major uterine malformations associated with adverse pregnancy outcomes.
- Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.
- Active drug use, alcohol use, or unstable psychiatric condition.
- Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.
- Prenatal care or delivery planned at a non-network center where access to the complete electronic medical record will not be available to research staff.
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
Where
- Birmingham, Alabama
- San Francisco, California
- Chicago, Illinois
- New York, New York
- Chapel Hill, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Providence, Rhode Island
- Galveston, Texas
- Houston, Texas
And 1 more location — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2026 · Source of record for eligibility and locations