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Recruiting

NCT Number: NCT04205370

Sleep Behaviors in Pregnancy

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

Recruiting

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Key information

Conditions

Sleep Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Louise O'Brien

CONTACT

[email protected]

(734)-647-9064

Louise O'Brien

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Louise O'Brien, PhD

CONTACT

[email protected]

(734)-647-9064

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2019
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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