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Improving Maternal Sleep and Mental Health

Key facts

Who runs it
University of Colorado, Colorado Springs
Where
Colorado Springs, United StatesSee the site
Trial code
Status
Recruiting
People taking part
342 people, planned
Started
15 Jan 2025
Expected to end
Jun 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Smart Bassinet
  • HALO
Record updated
10 February 2025

Who can take part

Age
18 years to 45 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation
  • 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
  • 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
  • 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
  • Under the age of 18 years or > 45 years. The goal is to include women of childbearing age
  • Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet
  • Tobacco use (current). Smoking is associated with poor sleep and inflammation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 45 years old?

Where in United States

  • University of Colorado Colorado SpringsColorado Springs, United StatesContact: Michele L Okun, Ph.D.Taking people

About the trial

What the trial wants to find out

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]:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Smart Bassinet (SB)Treatment being tested

    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.

    Treatment: Smart Bassinet

  • HALO Bassinet (TAU)Existing treatment, for comparison

    The HALO is a commercially available bassinet that does not have any robotic/responsive actions incorporated within it.

    Treatment: HALO

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet
Fit questions
Built from NCT06544941, who can take part
Record updated
10 February 2025