Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe George Washington University Biostatistics Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Continuous Positive Airway Pressure
- Sleep Advice Control
Treatment groups
1,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
The George Washington University Biostatistics Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov