Sleep Behaviors in Pregnancy

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT04205370
Status
Recruiting
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Conditions

  • Pregnancy Complications
  • Sleep

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Deactivated Pregnancy Coach — DEVICE
    Naturalistic monitoring of their typical sleep patterns and behaviors
  • 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.

Study Details

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

Key Dates

Start date
Jan 22, 2020
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Deactivated device
    Wear deactivated pregnancy coach device for the remainder of pregnancy.
  • Experimental: Active device
    Wear active device for remainder of pregnancy (including 3 day run-in period)

Primary Outcome Measure

Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach [ Time Frame: Until delivery, approximately 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Louise O'Brien
[email protected]
(734)-647-9064
Louise O'Brien (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MI

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