Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT04205370

Conditions

Sleep

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Deactivated Pregnancy Coach

Active Pregnancy Coach

Study Details

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

Study ID

NCT04205370

Start date

Jan 22, 2020

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: 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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Deactivated device

Wear deactivated pregnancy coach device for the remainder of pregnancy.

experimental: Active device

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

Interventions

Deactivated Pregnancy Coach

Naturalistic monitoring of their typical sleep patterns and behaviors

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.

Primary outcome measure

  • Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach [ Time Frame: Until delivery, approximately 12 weeks ]

Central Contacts and Locations

Central contacts

Louise O'Brien, PhD

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

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Louise O'Brien

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

Principal Investigator:

Louise O'Brien

More Information

Sponsor

University of Michigan

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-05-11.