Sleep Health in Pregnant Women in ENRICH | NCT07216287

Studies
Sleep Health in Pregnant Women in ENRICH

NCT07216287

Sponsor

Washington University School of Medicine

Status

Enrolling by invitation

Last Update Posted

Apr 24, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Pregnancy
Sleep

Interventions

No Intervention: Observational Cohort

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UH3HL162970	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Oct 2, 2025

First Submission Date that Met QC Criteria

Oct 8, 2025

First Posted Date

Oct 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 24, 2026Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention: Observational Cohort	Other	No intervention, observational cohort study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University in St. Louis		St Louis	Missouri	63110	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data (sleep health metrics, demographic and social determinants of health metrics) resulting from this research will be shared via the Washington University School of Medicine (WUSM) institutional data repository, Digital Commons Data@Becker.

Types

Not provided

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.

URL

Not provided