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

Active, not recruiting

• Conditions: Sleep; Pregnancy; Obesity; Obstructive Sleep Apnea

• Registration Number: NCT02917876
• Lead Sponsor: The Miriam Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Study Start: 2016-11
• Primary Completion: 2023-12-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• <13 completed weeks of gestation
• BMI >30 kg/m2 at recruitment
• >18 years of age
• Ability to give informed consent

Exclusion Criteria

• Unable to meet inclusion criteria
• Twin pregnancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characteristics of participants who develop obstructive sleep apnea defined as an apnea hypopnea index >5 events per hour	Up to 40 weeks	The study will develop a model of biologic, physiologic and anthropometric measures that predict the development of obstructive sleep apnea apnea later in pregnancy compared to baseline in early pregnancy.

Trial Locations

Locations (1)

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States