RecruitingObstructive Sleep Apnea of AdultPreeclampsiaObstetrical Complications

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

Eligible age

18+ yrs

Accepts

Women

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: The George Washington University Biostatistics Center

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.