Sleep Behaviors in Pregnancy

NCT04205370 | Recruiting FDA Device

• 1 other identifier: HUM00140170
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep; Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach

  Will be conducted using the naturalistic arm (deactivated device). Simple descriptive statistics to report the average number of minutes and the average proportion of supine sleep per week.

  Until delivery, approximately 12 weeks

Secondary Outcomes (3)

• Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach

  Until delivery, approximately 12 weeks

• Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position

  Until delivery, approximately 12 weeks

• Percentage of sleep position changes following alert from Pregnancy Coach

  Until delivery, approximately 12 weeks

Study Arms (2)

Deactivated device

ACTIVE COMPARATOR

Wear deactivated pregnancy coach device for the remainder of pregnancy.

Device: Deactivated Pregnancy Coach

Active device

EXPERIMENTAL

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

Device: Active Pregnancy Coach

Interventions

Deactivated Pregnancy Coach DEVICE

Naturalistic monitoring of their typical sleep patterns and behaviors

Deactivated device

Active Pregnancy Coach DEVICE

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

Active device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Less then 28 weeks pregnant
• Receiving pre-natal care external to Michigan Medicine
• Does not poses a smartphone

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Louise O'Brien, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise O'Brien, PhD

CONTACT

(734)-647-9064; louiseo@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: January 22, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)