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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02917876

Acronym

Predictors

Enrollment

450

Registered

2016-09-28

Start date

2016-11-30

Completion date

2025-05-01

Last updated

2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Obstructive Sleep Apnea, Pregnancy, Sleep

Keywords

Obstructive Sleep Apnea, Pregnancy, Obesity, Fluid shifts, Body composition, Sleep

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results