Actively Recruiting
Improving Maternal Sleep and Mental Health
Led by University of Colorado, Colorado Springs · Updated on 2025-02-10
342
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Colorado Springs
Lead Sponsor
U
University of Virginia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.
CONDITIONS
Official Title
Improving Maternal Sleep and Mental Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 the bassinet they are randomized to
- Willing to travel to a local Quest for blood draw
You will not qualify if you...
- Presence of current depression, active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence in the last 90 days
- Plans to co-sleep with infant exclusively
- Under 18 years or over 45 years of age
- Multiple gestations, Type 1 diabetes, or congenital fetal anomalies
- Current tobacco use
- Self-reported untreated sleep disorders including narcolepsy, periodic leg movement disorder, or obstructive sleep apnea
- Current use of psychotropic or sleep medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Colorado Springs
Colorado Springs, Colorado, United States, 80918
Actively Recruiting
Research Team
M
Michele L Okun, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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