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

NCT02917876 | Active Not Recruiting

• 1 other identifier: 1R01HL130702
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Pregnancy; Obesity; Sleep

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \<13 completed weeks of gestation
• BMI \>30 kg/m2 at recruitment
• \>18 years of age
• Ability to give informed consent

You may not qualify if:

• Twin pregnancies

Sponsors & Collaborators

• The Miriam Hospital: lead
• Brown University: collaborator
• Rhode Island Hospital: collaborator
• Women and Infants Hospital of Rhode Island: collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02904, United States

Location

Related Publications (2)

• Bublitz MH, Nillni Y, Nugent NR, Sanapo L, Habr N, Bourjeily G. Posttraumatic stress disorder, diurnal cortisol, and ambulatory blood pressure in early and late pregnancy. J Trauma Stress. 2023 Feb;36(1):239-246. doi: 10.1002/jts.22895. Epub 2022 Dec 4.

  PMID: 36464928 DERIVED

• Sanapo L, Bublitz MH, Bai A, Mehta N, Messerlian GM, Catalano P, Bourjeily G. Association between sleep disordered breathing in early pregnancy and glucose metabolism. Sleep. 2022 Apr 11;45(4):zsab281. doi: 10.1093/sleep/zsab281.

  PMID: 34999843 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be stored for future testing

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Ghada Bourjeily, MD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 28, 2016
• Study Start: November 1, 2016
• Primary Completion: December 30, 2023
• Study Completion: May 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Investigators data access requests will be reviewed by an independent review committee. Requestors will need to sign a data access agreement.

Locations

US (1)