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

November 20, 2024 updated by: Ghada Bourjeily, The Miriam Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • The Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women, 18 years or older, at less than 13 completed weeks of gestation and who have a BMI that is greater than 30 kg/m2 at recruitment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

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

Investigators

  • Principal Investigator: Ghada Bourjeily, MD, The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 30, 2023

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimated)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HL130702 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data for primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 12 months of study completion.

IPD Sharing Access Criteria

Investigators data access requests will be reviewed by an independent review committee. Requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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