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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deactivated device | Active Comparator | Wear deactivated pregnancy coach device for the remainder of pregnancy. |
|
| Active device | Experimental | Wear active device for remainder of pregnancy (including 3 day run-in period) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deactivated Pregnancy Coach | Device | Naturalistic monitoring of their typical sleep patterns and behaviors |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise O'Brien, PhD | Contact | (734)-647-9064 | louiseo@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Louise O'Brien, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
The study team does not have plans to actively share data, however, they are open to collaboration following contact with the investigator.
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Active Pregnancy Coach | Device | The Pregnancy Coach will begin to deliver alerts when supine sleep is detected. Sleep metrics will be visible on the smartphone app. |
|
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 |