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Obstructive Sleep Apnea of AdultSLEEPNCT03487185

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

A study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea of Adult and Preeclampsia, run by The George Washington University Biostatistics Center at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Continuous Positive Airway Pressure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
14 sitesUnited States
Study dates
3 Aug 2018to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • Case Western Reserve-Metro Health

    Cleveland, Ohio, 44109

  • Ohio State University Hospital

    Columbus, Ohio, 43210

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas - Houston

    Houston, Texas, 77030

  • Columbia University

    New York, New York, 10032

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Brown Univeristy

    Providence, Rhode Island, 02905

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

  • Regents of the University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Continuous Positive Airway Pressure, Sleep Advice Control
Keywords
CPAP, Apnea, pregnancy
Medical subject headings
Pre-Eclampsia, Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Positive Airway PressureDevice

    Also called CPAP

    Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling

  • Sleep Advice ControlOther

    Initial sleep advice counseling alone

Study groups in NCT03487185
Study groupRoleWhat they receive
Continuous Positive Airway PressureExperimentalAutotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
Receives: Device: Continuous Positive Airway Pressure
Sleep Advice ControlOtherInitial sleep advice counseling alone
Receives: Other: Sleep Advice Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnosis of Hypertensive Disorders of Pregnancy

    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.

    Measured: Up to 14 days postpartum

Secondary outcomes (16)

  1. Gestational diabetes

    Gestational diabetes by oral GTT criteria performed after randomization

    Measured: As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation

  2. Preterm birth

    Preterm birth less than 34 weeks and less than 37 weeks

    Measured: Preterm delivery up to and less than 37 weeks gestation

  3. Cesarean Delivery

    Delivery by cesarean section

    Measured: At the time of delivery

  4. Maternal morbidity composite

    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

    Measured: Within 6 weeks postpartum

  5. Maternal adverse cardiovascular outcome composite

    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

    Measured: By 6 weeks postpartum

  6. Fetal or Neonatal Death

    Antepartum, intrapartum, or neonatal death

    Measured: through 72 hours postpartum

  7. Neonatal respiratory support

    Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation

    Measured: within 72 hours of delivery

  8. Birth weight

    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

    Measured: Immediately post birth

  9. Neonatal encephalopathy

    Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria

    Measured: within 72 hours of delivery

  10. Neonatal Seizures

    Neonatal seizure activity confirmed by central review

    Measured: 72 hours post birth

  11. Shoulder dystocia

    Shoulder dystocia during delivery

    Measured: During delivery

  12. Birth trauma

    Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy

    Measured: During delivery

  13. Intracranial hemorrhage

    Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma

    Measured: Within 72 hours post delivery

  14. Hyperbilirubinemia

    Hyperbilirubinemia requiring phototherapy or exchange transfusion

    Measured: Within 72 hours post delivery

  15. Hypoglycemia

    glucose < 35 mg/dl requiring IV therapy

    Measured: Within 72 hours post delivery

  16. NICU Stay

    Neonatal Intensive Care Unit stay

    Measured: Greater than or equal to 72 hours post birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2018
  2. Study start3 Aug 2018
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Women who are between 14 weeks 0 days and 21 weeks 5 days with a singleton gestation and obstructive sleep apnea (OSA) will be randomized to one of two arms at participating MFMU Network clinical center: * Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling * Initial sleep advice counseling alone
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03487185
Sponsor's protocol ID
HD36801-SLEEP
Other IDs
U24HD036801, UG1HD087192, UG1HD087230, UG1HD027869, UG1HD034208, UG1HD053097, UG1HD040500, UG1HD040485
Acronym
SLEEP
Status last verified
Aug 2026
First submitted
22 Mar 2018
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The dataset will be shared per NIH policy after the completion and publication of the main analyses.

Publications

  • Facco F. Sleep Duration, Sleep Timing, and Sleep Disordered Breathing-Associations With Obesity and Gestational Diabetes in Pregnancy. Clin Obstet Gynecol. 2021 Mar 1;64(1):196-203. doi: 10.1097/GRF.0000000000000587.

    PubMed 33481418

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea of Adult and Preeclampsia, run by The George Washington University Biostatistics Center at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis of Hypertensive Disorders of Pregnancy (time frame: Up to 14 days postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03487185, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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