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

Sponsor

The Miriam Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02917876

Collaborator

Brown University (Other), Rhode Island Hospital (Other), Women and Infants Hospital of Rhode Island (Other)

450

Enrollment

Location

73.9

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Pregnancy Obesity Sleep

Detailed Description

Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will have:

measurements of body composition
anthropometric measures
sleep and mood questionnaires
Home sleep studies
blood testing for biological markers
salivary testing for hormonal markers
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 Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Outcome Measures

Primary Outcome Measures

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.