Sleep Behaviors in Pregnancy

NCT ID: NCT04205370

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The researchers would like to know how long pregnant women spend in different positions during the night - and how often women change positions - across pregnancy. The researchers also want to see if the sleep monitor is able to improve sleep behaviors

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Pregnancy Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Deactivated device

Wear deactivated pregnancy coach device for the remainder of pregnancy.

Group Type ACTIVE_COMPARATOR

Deactivated Pregnancy Coach

Intervention Type DEVICE

Naturalistic monitoring of their typical sleep patterns and behaviors

Active device

Wear active device for remainder of pregnancy (including 3 day run-in period)

Group Type EXPERIMENTAL

Active Pregnancy Coach

Intervention Type DEVICE

The Pregnancy Coach will begin to deliver alerts when supine sleep is detected. Sleep metrics will be visible on the smartphone app.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Deactivated Pregnancy Coach

Naturalistic monitoring of their typical sleep patterns and behaviors

Intervention Type DEVICE

Active Pregnancy Coach

The Pregnancy Coach will begin to deliver alerts when supine sleep is detected. Sleep metrics will be visible on the smartphone app.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 28 weeks pregnant
* Receiving pre-natal care at Michigan Medicine
* Have either and Android or iPhone smartphone

Exclusion Criteria

* Less then 28 weeks pregnant
* Receiving pre-natal care external to Michigan Medicine
* Does not poses a smartphone
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Louise O'Brien

Research Associate Professor, Neurology, Research Associate Professor, Obstetrics and Gynecology, Medical School and Associate Research Scientist, Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louise O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Louise O'Brien, PhD

Role: CONTACT

(734)-647-9064

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Louise O'Brien

Role: primary

734-647-9064

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUM00140170

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pregnancy 24/7 Offspring Study
NCT07172880 RECRUITING