Phase
Condition
Sleep Apnea Syndromes
Labor/delivery
Pregnancy Complications
Treatment
Continuous Positive Airway Pressure
Sleep Advice Control
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Study Description
Connect with a study center
University of Alabama - Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
Regents of the University of California San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
Columbia University
New York, New York 10032
United StatesActive - Recruiting
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Case Western Reserve-Metro Health
Cleveland, Ohio 44109
United StatesActive - Recruiting
Ohio State University Hospital
Columbus, Ohio 43210
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Brown Univeristy
Providence, Rhode Island 02905
United StatesSite Not Available
University of Texas Medical Branch
Galveston, Texas 77555
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
University of Texas - Houston
Houston, Texas 77030
United StatesActive - Recruiting
University of Utah Medical Center
Salt Lake City, Utah 84132
United StatesActive - Recruiting
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