Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2020-01-22
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Deactivated device
Wear deactivated pregnancy coach device for the remainder of pregnancy.
Deactivated Pregnancy Coach
Naturalistic monitoring of their typical sleep patterns and behaviors
Active device
Wear active device for remainder of pregnancy (including 3 day run-in period)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Receiving pre-natal care at Michigan Medicine
* Have either and Android or iPhone smartphone
Exclusion Criteria
* Receiving pre-natal care external to Michigan Medicine
* Does not poses a smartphone
18 Years
FEMALE
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Louise O'Brien
Research Associate Professor, Neurology, Research Associate Professor, Obstetrics and Gynecology, Medical School and Associate Research Scientist, Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry
Principal Investigators
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Louise O'Brien, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00140170
Identifier Type: -
Identifier Source: org_study_id
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