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

Lifespan

Status: Active, not recruiting

Conditions: Obesity; Sleep; Obstructive Sleep Apnea; Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT02917876

1R01HL130702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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