Sleep Behaviors in Pregnancy

Sleep Clinical Trial

Official title:

Sleep Behaviors in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04205370
• Other study ID #: HUM00140170
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Louise O'Brien, PhD
• Phone: (734)-647-9064
• Email: louiseo[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Sleep

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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