Sleep Behaviors in Pregnancy

Not Applicable

Recruiting

• Conditions: Sleep; Pregnancy Complications
• Interventions: Device: Deactivated Pregnancy Coach; Device: Active Pregnancy Coach

• Registration Number: NCT04205370
• Lead Sponsor: University of Michigan

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2020-01-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deactivated device	Deactivated Pregnancy Coach	Wear deactivated pregnancy coach device for the remainder of pregnancy.
Active device	Active Pregnancy Coach	Wear active device for remainder of pregnancy (including 3 day run-in period)

Primary Outcome Measures

Name	Time	Method
Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach	Until delivery, approximately 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position	Until delivery, approximately 12 weeks	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.
Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach	Until delivery, approximately 12 weeks	Will be conducted using the naturalistic arm (deactivated device). Proportion of time will be determined during each gestational week.
Percentage of sleep position changes following alert from Pregnancy Coach	Until delivery, approximately 12 weeks	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States