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OpenTrials
Enrolling by Invitation

NCT Number: NCT07216287

Sleep Health in Pregnant Women in ENRICH

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.

Enrolling by Invitation

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 18 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

Exclusion criteria

  • None

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention, observational cohort study

Primary outcomes

  1. Sleep Health

    Time frame: Baseline

    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".

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 14, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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