Sleep Health in Pregnant Women in ENRICH

NCT07216287 | Enrolling By Invitation

• 2 other identifiers: 202508143UH3HL162970
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal will study sleep health in pregnant women who are of low socioeconomic status (SES) and are participating in the NHLBI-funded UH3 grant: "Enhancing Cardiovascular (CV) Health in Mothers and Children Through Home Visiting (ENRICH)". Objective sleep health will be measured using an in-home sleep disordered breathing testing device and actigraphy and associations of sleep health with social determinants of health and CV health will be investigated. Data from this study will serve as the foundation for future work that will result in the development of sleep interventions and updated guidelines for screening and treatment of sleep in pregnancy.

Conditions

Pregnancy; Sleep

Outcome Measures

Primary Outcomes (1)

• Sleep Health

  A sleep health index will be calculated using 7-day wrist actigraphy, a single overnight home SDB testing device, and questionnaires. A sleep health index will be calculated using 10 sleep health components. Each component will be dichotomized with 0 indicating "poor" and 1 indicating "healthy". Scores will range from 0-10 with 0 being the poorest and 10 being completely healthy sleep, a score \<7 will indicate "poor sleep health".

  Baseline

Interventions

No Intervention: Observational Cohort OTHER

No intervention, observational cohort study

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

A subset of 50 participants from the Washington University clinical center of ENRICH will be enrolled in this study

You may qualify if:

• Currently enrolled in a HV agency participating in ENRICH
• Pregnant, with a single or multiple pregnancy, at or less than 34 weeks 0 days gestation
• years of age or older
• low SES (Medicaid eligibility or income at or below the federal poverty line) and/or African American Race and/or Hispanic/Latino ethnicity

You may not qualify if:

• None

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 14, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The sharable data produced by this project will be made accessible in a timely manner and no later than at the time of publication or by the end of the funding period, whichever occurs earlier. The duration of data preservation and sharing will be governed by the retention policies of Digital Commons Data@Becker
• Access Criteria: Data will be de-identified prior to sharing in digital Digital Commons Data@Becker and will be made available via controlled access to the approved users who sign the DUA (data use agreement) to ensure the requestor has a legitimate reason for access, agrees not to attempt re-identification, and not to redistribute data to unauthorized users.

Locations

US (1)