Pregnancy Complications, Sleep
Conditions
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
Interventions
DEVICEDeactivated Pregnancy Coach
Naturalistic monitoring of their typical sleep patterns and behaviors
DEVICEActive Pregnancy Coach
The Pregnancy Coach will begin to deliver alerts when supine sleep is detected. Sleep metrics will be visible on the smartphone app.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach | Until delivery, approximately 12 weeks | 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 | 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. |
| Percentage of sleep position changes following alert from Pregnancy Coach | 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. |
Countries
United States
Contacts
CONTACTLouise O'Brien, PhD
PRINCIPAL_INVESTIGATORLouise O'Brien, PhD
University of Michigan
Outcome results
None listed