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Behavioural Intervention

Pregnancy Sleep Coaching for Sleep in Pregnancy

N/A
Recruiting
Led By Louise O'Brien, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Less then 28 weeks pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until delivery, approximately 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a sleep monitor to see if it can help improve sleep behaviors in pregnant women.

Who is the study for?
This trial is for pregnant women who are at least 28 weeks along and receiving prenatal care at Michigan Medicine. Participants must own an Android or iPhone smartphone. Women less than 28 weeks pregnant, without a smartphone, or getting prenatal care outside of Michigan Medicine cannot join.
What is being tested?
The study is testing two types of pregnancy coaches: one active and one deactivated. Researchers want to see how these devices affect sleep positions and movements during the night in late-stage pregnancy, aiming to improve sleep behaviors.
What are the potential side effects?
Since this trial involves non-invasive monitoring with a pregnancy coach device, side effects are minimal but may include discomfort due to wearing the device during sleep or potential anxiety from being monitored.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am less than 28 weeks pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until delivery, approximately 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and until delivery, approximately 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach
Secondary study objectives
Percentage of sleep position changes following alert from Pregnancy Coach
Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position
Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active deviceExperimental Treatment1 Intervention
Wear active device for remainder of pregnancy (including 3 day run-in period)
Group II: Deactivated deviceActive Control1 Intervention
Wear deactivated pregnancy coach device for the remainder of pregnancy.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,852 Previous Clinical Trials
6,432,242 Total Patients Enrolled
2 Trials studying Pregnancy Complications
350 Patients Enrolled for Pregnancy Complications
Louise O'Brien, PhDPrincipal Investigator - University of Michigan
University of Michigan
1 Previous Clinical Trials

Media Library

Active Pregnancy Coach (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04205370 — N/A
Pregnancy Complications Research Study Groups: Active device, Deactivated device
Pregnancy Complications Clinical Trial 2023: Active Pregnancy Coach Highlights & Side Effects. Trial Name: NCT04205370 — N/A
Active Pregnancy Coach (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205370 — N/A
~146 spots leftby Dec 2026
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