Sleep Behaviors in Pregnancy

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

Study Overview

• Status: Recruiting
• Conditions: Sleep; Pregnancy Complications
• Intervention / Treatment: Device: Deactivated Pregnancy Coach; Device: Active Pregnancy Coach

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louise O'Brien, PhD; Phone Number: (734)-647-9064; Email: louiseo@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Louise O'Brien
      • Contact: Louise O'Brien; Phone Number: (734)-647-9064; Email: louiseo@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Deactivated device; Wear deactivated pregnancy coach device for the remainder of pregnancy.	Device: Deactivated Pregnancy Coach; Naturalistic monitoring of their typical sleep patterns and behaviors
Experimental: Active device; Wear active device for remainder of pregnancy (including 3 day run-in period)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach	Will be conducted using the naturalistic arm (deactivated device). Proportion of time will be determined during each gestational week.	Until delivery, approximately 12 weeks
Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position	Will be conducted using the naturalistic arm (deactivated device). We will determine whether the "going to sleep" position during each gestational week is predictive of the most dominant sleep position.	Until delivery, approximately 12 weeks
Percentage of sleep position changes following alert from Pregnancy Coach	Will be conducted using the intervention arm (active device). Percentage of sleep position changes in response to an alert from the Pregnancy Coach will be reported for each gestational week.	Until delivery, approximately 12 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Louise O'Brien, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications
• Other Study ID Numbers: HUM00140170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study team does not have plans to actively share data, however, they are open to collaboration following contact with the investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No