search
Back to results

Sleep Behaviors in Pregnancy

Primary Purpose

Sleep, Pregnancy Complications

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deactivated Pregnancy Coach
Active Pregnancy Coach
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Deactivated device

Active device

Arm Description

Wear deactivated pregnancy coach device for the remainder of pregnancy.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 17, 2019
Last Updated
February 6, 2023
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT04205370
Brief Title
Sleep Behaviors in Pregnancy
Official Title
Sleep Behaviors in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Pregnancy Complications

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deactivated device
Arm Type
Active Comparator
Arm Description
Wear deactivated pregnancy coach device for the remainder of pregnancy.
Arm Title
Active device
Arm Type
Experimental
Arm Description
Wear active device for remainder of pregnancy (including 3 day run-in period)
Intervention Type
Device
Intervention Name(s)
Deactivated Pregnancy Coach
Intervention Description
Naturalistic monitoring of their typical sleep patterns and behaviors
Intervention Type
Device
Intervention Name(s)
Active Pregnancy Coach
Intervention Description
The Pregnancy Coach will begin to deliver alerts when supine sleep is detected. Sleep metrics will be visible on the smartphone app.
Primary Outcome Measure Information:
Title
Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach
Description
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 Outcome Measure Information:
Title
Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach
Description
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
Title
Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position
Description
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
Title
Percentage of sleep position changes following alert from Pregnancy Coach
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louise O'Brien, PhD
Phone
(734)-647-9064
Email
louiseo@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise O'Brien, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise O'Brien
Phone
734-647-9064
Email
louiseo@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Louise O'Brien

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study team does not have plans to actively share data, however, they are open to collaboration following contact with the investigator.

Learn more about this trial

Sleep Behaviors in Pregnancy

We'll reach out to this number within 24 hrs