Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Behaviors in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04205370
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Louise O'Brien, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Sleep Pregnancy Complications Device: Deactivated Pregnancy Coach Device: Active Pregnancy Coach Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sleep Behaviors in Pregnancy
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Deactivated device
Wear deactivated pregnancy coach device for the remainder of pregnancy.
 Device: Deactivated Pregnancy Coach
Naturalistic monitoring of their typical sleep patterns and behaviors
Experimental: Active device
Wear active device for remainder of pregnancy (including 3 day run-in period)
 Device: Active Pregnancy Coach
The Pregnancy Coach will begin to deliver alerts when supine sleep is detected. Sleep metrics will be visible on the smartphone app.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach [ Time Frame: Until delivery, approximately 12 weeks ]
    Will be conducted using the naturalistic arm (deactivated device). Proportion of time will be determined during each gestational week.

  2. Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position [ Time Frame: Until delivery, approximately 12 weeks ]
    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.

  3. Percentage of sleep position changes following alert from Pregnancy Coach [ Time Frame: Until delivery, approximately 12 weeks ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205370


Contacts
Layout table for location contacts
Contact: Joslin Musick, MS (734)-232-4600 jrmusick@med.umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Joslin Musick, MS    734-232-4600    jrmusick@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Louise O'Brien, PhD University of Michigan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Louise O'Brien, Research Associate Professor, Neurology, Research Associate Professor, Obstetrics and Gynecology, Medical School and Associate Research Scientist, Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT04205370    
Other Study ID Numbers: HUM00140170
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study team does not have plans to actively share data, however, they are open to collaboration following contact with the investigator.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pregnancy Complications