Recruiting NCT04205370
Sleep Behaviors in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deactivated Pregnancy Coach, Active Pregnancy Coach.
- Who it may be relevant to
- Registry conditions: Sleep, Pregnancy Complications. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Device Deactivated Pregnancy Coach
Naturalistic monitoring of their typical sleep patterns and behaviors - 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.
Primary outcome measures
- Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach [Time frame: Until delivery, approximately 12 weeks]
Secondary outcome measures (3)
- Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach [Time frame: Until delivery, approximately 12 weeks]
- Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position [Time frame: Until delivery, approximately 12 weeks]
- Percentage of sleep position changes following alert from Pregnancy Coach [Time frame: Until delivery, approximately 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT04205370 · HUM00140170