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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until delivery, approximately 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until delivery, approximately 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until delivery, approximately 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach
Secondary outcome measures
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
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
1,786 Previous Clinical Trials
6,365,022 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You own a smartphone that uses the Android or iPhone operating system.You need to have a smartphone that runs on Android or iPhone operating system.I am less than 28 weeks pregnant.You don't have a smartphone.
Research Study Groups:
This trial has the following groups:- Group 1: Active device
- Group 2: Deactivated device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are partaking in the experiment?
"Right. According to clinicaltrials.gov, this medical experiment is presently calling for volunteers; the trial was first posted on January 22nd 2020 and updated lastly on January 27th 2022. The research necessitates 500 test subjects from one site in total."
Answered by AI
Are the researchers currently enrolling new participants for this trial?
"This clinical trial is still accepting participants, as per the records on clinicaltrials.gov that were originally posted on January 22nd 2020 and most recently updated on January 27th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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