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

Obesity Clinical Trial

— Predictors  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02917876
• Other study ID #: 1R01HL130702
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnea
• Pregnancy
• Sleep
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of participants who develop obstructive sleep apnea defined as an apnea hypopnea index >5 events per hour	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.	Up to 40 weeks