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Sleep Health in Pregnant Women in ENRICH

Enhancing Cardiovascular Health in Mothers and Children Through Home Visiting (Supplement)

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07216287
Enrollment
50
Registered
2025-10-14
Start date
2025-11-03
Completion date
2026-08-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Sleep

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.

Interventions

OTHERNo Intervention: Observational Cohort

No intervention, observational cohort study

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Currently enrolled in a HV agency participating in ENRICH 2. Pregnant, with a single or multiple pregnancy, at or less than 34 weeks 0 days gestation 3. 18 years of age or older 4. low SES (Medicaid eligibility or income at or below the federal poverty line) and/or African American Race and/or Hispanic/Latino ethnicity

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Sleep HealthBaselineA 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".

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026