Health TrialsbyHealthPanel

Sleep Behaviors in Pregnancy

ConditionsSleepPregnancy Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Michigan

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least 28 weeks pregnant

Receiving pre-natal care at Michigan Medicine

Have either and Android or iPhone smartphone

Disqualifiers

Less then 28 weeks pregnant

Receiving pre-natal care external to Michigan Medicine

Does not poses a smartphone

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Deactivated deviceActive comparator 1 intervention
Group B: Active deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Until delivery, approximately 12 weeks

Secondary outcomes

1

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.

Time frame
Until delivery, approximately 12 weeks
2

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.

Time frame
Until delivery, approximately 12 weeks
3

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.

Time frame
Until delivery, approximately 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov
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