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

NCT03487185 | Recruiting DMC FDA Device

• 17 other identifiers: HD36801-SLEEPU24HD036801UG1HD087192UG1HD087230UG1HD027869UG1HD034208UG1HD053097UG1HD040500UG1HD040485UG1HD040544UG1HD040545UG1HD040560UG1HD040512UG1HD027915UG1HD112096UG1HD112063UG1HD112092
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Obstructive Sleep Apnea of Adult; Preeclampsia; Obstetrical Complications

Keywords

CPAP; Apnea; pregnancy

Outcome Measures

Primary Outcomes (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.

  Up to 14 days postpartum

Secondary Outcomes (16)

• Gestational diabetes

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

• Preterm birth

  Preterm delivery up to and less than 37 weeks gestation

• Cesarean Delivery

  At the time of delivery

• Maternal morbidity composite

  Within 6 weeks postpartum

• Maternal adverse cardiovascular outcome composite

  By 6 weeks postpartum

Study Arms (2)

Continuous Positive Airway Pressure

EXPERIMENTAL

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

Device: Continuous Positive Airway Pressure

Sleep Advice Control

OTHER

Initial sleep advice counseling alone

Other: Sleep Advice Control

Interventions

Continuous Positive Airway Pressure DEVICE

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

Also known as: CPAP

Continuous Positive Airway Pressure

Sleep Advice Control OTHER

Initial sleep advice counseling alone

Sleep Advice Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

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

Study Sites (14)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Regents of the University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Case Western Reserve-Metro Health

Cleveland, Ohio, 44109, United States

RECRUITING

Ohio State University Hospital

Columbus, Ohio, 43210, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Brown Univeristy

Providence, Rhode Island, 02905, United States

ACTIVE NOT RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Texas - Houston

Houston, Texas, 77030, United States

RECRUITING

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33481418 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Apnea

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Rebecca Clifton, PhD

  The George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

• Monica Longo, MD

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  STUDY DIRECTOR

• Francesca Facco, MD

  Magee Women's Hospital of UPMC

  STUDY CHAIR

Central Study Contacts

Rebecca Clifton, PhD

CONTACT

301-881-9260; rclifton@bsc.gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is an unmasked randomized controlled multi-center clinical trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 3, 2018
• Study Start: August 3, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (14)