NCT02412696

Positive Airway Pressure, Sleep Apnea, and the Placenta (PAP-SAP)

Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is testing the hypothesis of whether continuous positive airway pressure (CPAP) therapy improves placental histopathology and secretory function. The main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions.

Detailed 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 Obstructive Sleep Apnea will then be randomized to one of two groups (below). Both groups will have: 1. blood testing for placenta-secreted circulating markers 2. 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: 1. Nasal dilator strips: Participants receiving nasal dilator strips will be monitored by need for refill of supplies and periodic phone calls. 2. 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.

Conditions

• Obstructive Sleep Apnea
• Pregnancy
• Obesity
• Preeclampsia
• Sleep

Interventions

Type	Name	Description
DEVICE	Positive Airway Pressure	Auto-titrating PAP + nasal dilator strips during sleep
OTHER	Nasal Dilator Strips	Nasal dilator strips

Timeline

• Start date: 2015-06-01
• Primary completion: 2020-08-01
• Completion: 2025-05-01
• First posted: 2015-04-09
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States