Trials / Recruiting
RecruitingNCT03487185
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,500 (estimated)
- Sponsor
- The George Washington University Biostatistics Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Continuous Positive Airway Pressure | Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling |
| OTHER | Sleep Advice Control | Initial sleep advice counseling alone |
Timeline
- Start date
- 2018-08-03
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2018-04-03
- Last updated
- 2026-04-06
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03487185. Inclusion in this directory is not an endorsement.