Sleep Behaviors in Pregnancy

University of Michigan

Status: Enrolling

Conditions: Pregnancy Complications; Sleep

Treatments: Device: Deactivated Pregnancy Coach; Device: Active Pregnancy Coach

Study type: Interventional

Funder types: Other

Identifiers

NCT04205370

HUM00140170

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Deactivated device

Active Comparator group

Description:

Wear deactivated pregnancy coach device for the remainder of pregnancy.

Treatment:

Device: Deactivated Pregnancy Coach

Active device

Experimental group

Description:

Wear active device for remainder of pregnancy (including 3 day run-in period)

Treatment:

Device: Active Pregnancy Coach