Status:
RECRUITING
Improving Maternal Sleep and Mental Health
Lead Sponsor:
University of Colorado, Colorado Springs
Collaborating Sponsors:
University of Virginia
Weill Medical College of Cornell University
Conditions:
Postpartum Depression
Postpartum Anxiety
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investiga...
Detailed Description
The investigators propose to conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use the SB or a standard commercially available bassinet (Halo Bassin...
Eligibility Criteria
Inclusion
- Pregnant women with a singleton gestation who have a military affiliation
- Ages 18-45 years
- Ability to communicate during the screening process
- Access to a computer, smart phone or tablet with internet service
- Willing to use bassinet they are randomized to
- Willing to travel to a local Quest for blood draw
Exclusion
- Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.
- Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.
- Under the age of 18 years or \> 45 years. The goal is to include women of childbearing age.
- Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.
- Tobacco use (current). Smoking is associated with poor sleep and inflammation.
- Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.
- Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT06544941
Start Date
January 15 2025
End Date
June 1 2028
Last Update
February 10 2025
Active Locations (1)
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1
University of Colorado Colorado Springs
Colorado Springs, Colorado, United States, 80918