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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

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1 of 1500 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Birmingham

Alabama

Location available
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San Francisco

California

Location available
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Chicago

Illinois

Location available
RECRUITING

New York

New York

Location available
RECRUITING

Chapel Hill

North Carolina

Location available
RECRUITING

Cleveland

Ohio

Location available
RECRUITING

Columbus

Ohio

Location available
RECRUITING

Philadelphia

Pennsylvania

Location available
RECRUITING

Pittsburgh

Pennsylvania

Location available

And 5 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Obstructive Sleep Apnea of Adult Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Obstructive Sleep Apnea of Adult Treatment Options in Birmingham, Alabama

If you're searching for Obstructive Sleep Apnea of Adult treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, San Francisco, Chicago and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Obstructive Sleep Apnea of Adult. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 1500 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Obstructive Sleep Apnea of Adult?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Obstructive Sleep Apnea of Adult

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Obstructive Sleep Apnea of Adult Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT03487185. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.