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

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: Recruiting
• Conditions: Obstructive Sleep Apnea of Adult; Preeclampsia; Obstetrical Complications
• Intervention / Treatment: Device: Continuous Positive Airway Pressure; Other: Sleep Advice Control

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: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Clifton, PhD; Phone Number: 301-881-9260; Email: rclifton@bsc.gwu.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama - Birmingham
      • Principal Investigator: Alan TN Tita, MD
      • Contact: Nancy Saxon, RN; Phone Number: 205-934-1616; Email: nbsaxon@uabmc.edu
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • Regents of the University of California San Francisco
      • Principal Investigator: Mary Norton, MD
      • Contact: Natalie Oman, MPH; Phone Number: 206-718-4703; Email: natalie.oman@ucsf.edu
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Principal Investigator: Lynn Yee, MD
      • Contact: Elizabeth Rangel, MSN; Phone Number: 312-503-6287; Email: elizabeth.rangel@northwestern.edu
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
      • Contact: Megan Loffredo, MD, CCRC; Phone Number: 203-722-1058; Email: ml4639@cumc.columbia.edu
      • Principal Investigator: Noelia Zork, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina - Chapel Hill
      • Contact: Kelly Clark, RN; Phone Number: 919-350-6117; Email: kelly_clark@med.unc.edu
      • Principal Investigator: John M Thorp, MD
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Recruiting
      • Case Western Reserve-Metro Health
      • Principal Investigator: Kelly Gibson, MD
      • Contact: Abigail Pierse, BS; Phone Number: 216-778-8443; Email: apierse@metrohealth.org
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Hospital
      • Principal Investigator: Maged Costantine, MD
      • Contact: Anna Bartholomew, RN; Phone Number: 614-685-3229; Email: anna.bartholomew@osumc.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Principal Investigator: Lorraine Dugoff, MD
      • Contact: Amee Feager, RN; Phone Number: 636-699-3433; Email: amee.feager@pennmedicine.upenn.edu
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Magee Women's Hospital of UPMC
      • Principal Investigator: Hyagriv Simhan, MD
      • Contact: Jeanette Boyce, RN; Phone Number: 412-527-8118; Email: tessje@upmc.edu
  • 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: Christina Reed, RN, NP; Phone Number: 832-826-7377; Email: christina.reed@bcm.edu
      • Contact: Jia Chen, RN, CCRP; Phone Number: 713-798-3798; Email: jia.chen@bcm.edu
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas - Houston
      • Principal Investigator: Hector Mendez-Figueroa, MD
      • Contact: Felecia Ortiz, RN; Phone Number: 713-500-6467; Email: felecia.ortiz@uth.tmc.edu
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Medical Center
      • Principal Investigator: Torri Metz, MD
      • Contact: Amber Sowles, RN, BSN, CCRP; Phone Number: 801-585-5499; Email: amber.sowles@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Up to 14 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational diabetes	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	Preterm birth less than 34 weeks and less than 37 weeks	Preterm delivery up to and less than 37 weeks gestation
Cesarean Delivery	Delivery by cesarean section	At the time of delivery
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	Within 6 weeks postpartum
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	By 6 weeks postpartum
Fetal or Neonatal Death	Antepartum, intrapartum, or neonatal death	through 72 hours postpartum
Neonatal respiratory support	Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation	within 72 hours of delivery
Birth weight	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; Large for gestational age defined as greater than the 90th percentile for gestational age.; Macrosomia defined as birthweight > 4000 grams	Immediately post birth
Neonatal encephalopathy	Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria	within 72 hours of delivery
Neonatal Seizures	Neonatal seizure activity confirmed by central review	72 hours post birth
Shoulder dystocia	Shoulder dystocia during delivery	During delivery
Birth trauma	Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy	During delivery
Intracranial hemorrhage	Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma	Within 72 hours post delivery
Hyperbilirubinemia	Hyperbilirubinemia requiring phototherapy or exchange transfusion	Within 72 hours post delivery
Hypoglycemia	glucose < 35 mg/dl requiring IV therapy	Within 72 hours post delivery
NICU Stay	Neonatal Intensive Care Unit stay	Greater than or equal to 72 hours post birth

Collaborators and Investigators

• Sponsor: The George Washington University Biostatistics Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: 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

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; CPAP; Apnea
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Respiratory Tract Diseases; Respiration Disorders; Hypertension, Pregnancy-Induced; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pre-Eclampsia; Apnea; Therapeutics; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure
• Other Study ID 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