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

April 3, 2026 updated by: The George Washington University Biostatistics Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes. In particular, women with obstructive sleep apnea (OSA) appear to be at increased risk of both hypertensive disorders of pregnancy and gestational diabetes. In the non-pregnant population, OSA is typically treated with continuous positive airway pressure (CPAP) during sleep and has been shown to reduce blood pressure in hypertensive patients. Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited. This study aims to address this knowledge gap.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama - Birmingham
        • Principal Investigator:
          • Alan TN Tita, MD
        • Contact:
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • Regents of the University of California San Francisco
        • Principal Investigator:
          • Mary Norton, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Lynn Yee, MD
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
        • Principal Investigator:
          • Noelia Zork, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina - Chapel Hill
        • Contact:
        • Principal Investigator:
          • John M Thorp, MD
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • Case Western Reserve-Metro Health
        • Principal Investigator:
          • Kelly Gibson, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Hospital
        • Principal Investigator:
          • Maged Costantine, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Principal Investigator:
          • Lorraine Dugoff, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Magee Women's Hospital of UPMC
        • Principal Investigator:
          • Hyagriv Simhan, MD
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Active, not recruiting
        • Brown Univeristy
    • Texas
      • Galveston, Texas, United States, 77555
        • Active, not recruiting
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Catherine Eppes, MD, MPH
        • Contact:
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas - Houston
        • Principal Investigator:
          • Hector Mendez-Figueroa, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Medical Center
        • Principal Investigator:
          • Torri Metz, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
  2. Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
  3. Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30.

Exclusion Criteria

  1. Previously prescribed, current or planned therapy for sleep apnea.
  2. Age < 18 years, because the rate of sleep apnea in this population is extremely low.
  3. Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.
  4. 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.
  5. Current use of prescribed sleeping pills for insomnia.
  6. 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.
  7. Chronic renal disease with serum creatinine >1.3 mg/dL because the primary outcome would be pre-determined.
  8. Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.

  9. History of medical complications such as:

    1. Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
    2. Thrombocytopenia with platelet count <100,000 because of the difficulty in assessing the primary outcome.
  10. Active vaginal bleeding (more than spotting) at the time of randomization.
  11. Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.
  12. Known major uterine malformations associated with adverse pregnancy outcomes.
  13. Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.
  14. Active drug use, alcohol use, or unstable psychiatric condition.
  15. Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.
  16. 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.
  17. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Continuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
Device: Continuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
Other Names:
  • CPAP
Other: Sleep Advice Control
Initial sleep advice counseling alone
Other: Sleep Advice Control
Initial sleep advice counseling alone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnosis of Hypertensive Disorders of Pregnancy
Time Frame: Up to 14 days postpartum
Subjects are considered to have the primary outcome if they meet the criteria for eclampsia, HELLP, atypical HELLP, preeclampsia, superimposed preeclampsia or antepartum gestational hypertension.
Up to 14 days postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gestational diabetes
Time Frame: As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation
Gestational diabetes by oral GTT criteria performed after randomization
As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation
Preterm birth
Time Frame: Preterm delivery up to and less than 37 weeks gestation
Preterm birth less than 34 weeks and less than 37 weeks
Preterm delivery up to and less than 37 weeks gestation
Cesarean Delivery
Time Frame: At the time of delivery
Delivery by cesarean section
At the time of delivery
Maternal morbidity composite
Time Frame: Within 6 weeks postpartum

Maternal morbidity composite defined as the occurrence of one of the following:

  • Maternal death
  • Transfusion of ≥ 4 units of PRBC within 6 weeks postpartum
  • ICU admission within 6 weeks postpartum
Within 6 weeks postpartum
Maternal adverse cardiovascular outcome composite
Time Frame: By 6 weeks postpartum

Maternal adverse cardiovascular outcome composite defined as the occurrence of one or more of the following:

  • Venous thromboembolism
  • New onset heart failure with ejection fraction (EF) < 40%
  • Cerebrovascular accident
  • Myocardial infarction
  • New onset atrial fibrillation
By 6 weeks postpartum
Fetal or Neonatal Death
Time Frame: through 72 hours postpartum
Antepartum, intrapartum, or neonatal death
through 72 hours postpartum
Neonatal respiratory support
Time Frame: within 72 hours of delivery
Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation
within 72 hours of delivery
Birth weight
Time Frame: Immediately post birth
  1. Small for gestational age defined as < 5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data
  2. Large for gestational age defined as greater than the 90th percentile for gestational age.
  3. Macrosomia defined as birthweight > 4000 grams
Immediately post birth
Neonatal encephalopathy
Time Frame: within 72 hours of delivery
Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria
within 72 hours of delivery
Neonatal Seizures
Time Frame: 72 hours post birth
Neonatal seizure activity confirmed by central review
72 hours post birth
Shoulder dystocia
Time Frame: During delivery
Shoulder dystocia during delivery
During delivery
Birth trauma
Time Frame: During delivery
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
During delivery
Intracranial hemorrhage
Time Frame: Within 72 hours post delivery
Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Within 72 hours post delivery
Hyperbilirubinemia
Time Frame: Within 72 hours post delivery
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Within 72 hours post delivery
Hypoglycemia
Time Frame: Within 72 hours post delivery
glucose < 35 mg/dl requiring IV therapy
Within 72 hours post delivery
NICU Stay
Time Frame: Greater than or equal to 72 hours post birth
Neonatal Intensive Care Unit stay
Greater than or equal to 72 hours post birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The George Washington University Biostatistics Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Monica Longo, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Study Chair: Francesca Facco, MD, Magee Women's Hospital of UPMC
  • Principal Investigator: Rebecca Clifton, PhD, The George Washington University Biostatistics Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HD36801-SLEEP
  • UG1HD087230 (U.S. NIH Grant/Contract)
  • UG1HD027869 (U.S. NIH Grant/Contract)
  • UG1HD040500 (U.S. NIH Grant/Contract)
  • UG1HD034208 (U.S. NIH Grant/Contract)
  • UG1HD027915 (U.S. NIH Grant/Contract)
  • UG1HD040485 (U.S. NIH Grant/Contract)
  • UG1HD053097 (U.S. NIH Grant/Contract)
  • UG1HD040544 (U.S. NIH Grant/Contract)
  • UG1HD040545 (U.S. NIH Grant/Contract)
  • UG1HD040560 (U.S. NIH Grant/Contract)
  • UG1HD040512 (U.S. NIH Grant/Contract)
  • UG1HD087192 (U.S. NIH Grant/Contract)
  • U24HD036801 (U.S. NIH Grant/Contract)
  • UG1HD112063 (U.S. NIH Grant/Contract)
  • UG1HD112092 (U.S. NIH Grant/Contract)
  • UG1HD112096 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The dataset will be shared per NIH policy after the completion and publication of the main analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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