NCT02917876

Predictors of De-novo Development of Obstructive Sleep Apnea in Pregnancy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific predictive factors can help identify a population at risk and guide clinicians to develop suitable targeting screening strategies.

Detailed description

Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will have: 1. measurements of body composition 2. anthropometric measures 3. sleep and mood questionnaires 4. Home sleep studies 5. blood testing for biological markers 6. salivary testing for hormonal markers 7. pulmonary function tests and upper airway patency measurements Women without sleep apnea at enrollment will then be followed longitudinally for the development of obstructive sleep apnea during pregnancy with repeat assessment during their third trimester. Women diagnosed with sleep apnea at enrollment will have no further assessment in late pregnancy. Monetary incentives will also be issued at data collection points. Subjects will receive small gift incentives such as baby-related items.

Conditions

• Obstructive Sleep Apnea
• Pregnancy
• Obesity
• Sleep

Timeline

• Start date: 2016-11-01
• Primary completion: 2023-12-30
• Completion: 2025-05-01
• First posted: 2016-09-28
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States