Sleep Behaviors in Pregnancy

Study Overview
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Brief Summary
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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

Official Title
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Sleep Behaviors in Pregnancy

Conditions
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Sleep, Pregnancy Complications

Intervention / Treatment
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* Device: Deactivated Pregnancy Coach
* Device: Active Pregnancy Coach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deactivated device<br>Wear deactivated pregnancy coach device for the remainder of pregnancy. | Device: Deactivated Pregnancy Coach<br>* Naturalistic monitoring of their typical sleep patterns and behaviors<br>|
| Experimental: Active device<br>Wear active device for remainder of pregnancy (including 3 day run-in period) | Device: Active Pregnancy Coach<br>* The Pregnancy Coach will begin to deliver alerts when supine sleep is detected. Sleep metrics will be visible on the smartphone app.<br>|

What is the study measuring?
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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 |