Positive Airway Pressure, Sleep Apnea, and the Placenta (PAP-SAP)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity
- Obstructive Sleep Apnea
- Preeclampsia
- Pregnancy
- Sleep
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will be given a physical exam, have measurements taken, answer questionnaires and then will be screened using a home sleep apnea test (HSAT) Type III device. Those diagnosed with Ob...
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will be given a physical exam, have measurements taken, answer questionnaires and then will be screened using a home sleep apnea test (HSAT) Type III device. Those diagnosed with Obstructive Sleep Apnea will then be randomized to one of two groups (below). Both groups will have: blood testing for placenta-secreted circulating markers placental histopathological and immunohistochemistry examination of placental expression of markers. Both groups will answer sleep and mood questionnaires, have blood pressure, blood glucose and activity / sleep watch monitoring and will receive an educational session on pregnancy health. Randomization groups include: Nasal dilator strips: Participants receiving nasal dilator strips will be monitored by need for refill of supplies and periodic phone calls. CPAP + nasal dilator strips: Subjects randomized to positive airway pressure (PAP) therapy will receive auto-titrating PAP. Pressure requirements will be monitored remotely and pressure modified as needed. PAP adherence will be determined subjectively and objectively. This group will also receive nasal dilator strips as described above. All subjects will receive small gift incentives such as baby-related items. Monetary incentives will also be issued at data collection points.
Tracking Information
- NCT #
- NCT02412696
- Collaborators
- Brown University
- Rhode Island Hospital
- Women and Infants Hospital of Rhode Island
- Brigham and Women's Hospital
- Investigators
- Principal Investigator: Ghada Bourjeily, MD The Miriam Hospital