Improving Maternal Sleep and Mental Health

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
University of Colorado, Colorado Springs
Study ID
NCT06544941
Status
Recruiting
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Conditions

  • Infant Behavior
  • Inflammation
  • Maternal Behavior
  • Military Family
  • Postpartum Anxiety
  • Postpartum Depression
  • Sleep Disturbance

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Smart Bassinet — DEVICE
    The SNOO will respond to a crying or fussing infant in order to soothe and calm it down.
  • HALO — DEVICE
    The HALO is a commercially available bassinet

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Aug 2024
Primary completion
Aug 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
342 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Smart Bassinet (SB)
    The SB responds to an infant who is fussing or crying by initiating "swaying" movement and "shushing" sounds with white noise that incrementally increase until the infant calms or the caregiver shuts it off. It will help babies transition into life outside of the womb with ease, enabling them to feel safe and secure, which translates to more sleep.
  • Active Comparator: HALO Bassinet (TAU)
    The HALO is a commercially available bassinet that does not have any robotic/responsive actions incorporated within it.

Primary Outcome Measure

Maternal Mood [ Time Frame: 0-6 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Colorado SpringsColorado SpringsColorado80918
Michele L Okun, Ph.D.
[email protected]
412-302-8030
Michele L Okun, Ph.D. (PRINCIPAL_INVESTIGATOR)

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