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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obstructive Sleep Apnea Apnea Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Miriam Hospital

Providence, Rhode Island, 02904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Characteristics of participants who develop obstructive sleep apnea defined as an apnea hypopnea index >5 events per hour

Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

Brown University
Rhode Island Hospital
Women and Infants Hospital of Rhode Island

Registry information

Acronym: Predictors

Important dates

Study start: 2016
Primary completion: 2023
Study completion: 2025
First posted: Sep 28, 2016
Registry last updated: Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting