Sleep Behaviors in Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04205370|
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : January 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Sleep Pregnancy Complications||Device: Deactivated Pregnancy Coach Device: Active Pregnancy Coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleep Behaviors in Pregnancy|
|Actual Study Start Date :||January 22, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
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.
- Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach [ Time Frame: 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.
- Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach [ Time Frame: Until delivery, approximately 12 weeks ]Will be conducted using the naturalistic arm (deactivated device). Proportion of time will be determined during each gestational week.
- Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position [ Time Frame: 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.
- Percentage of sleep position changes following alert from Pregnancy Coach [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205370
|Contact: Louise O'Brien, PhD||(734)-email@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Joslin Musick, MS 734-232-4600 firstname.lastname@example.org|
|Principal Investigator:||Louise O'Brien, PhD||University of Michigan|