Recruiting

Observational Study

Sponsor:

University of Colorado, Colorado Springs

Code:

NCT06544941

Conditions

Postpartum Depression

Postpartum Anxiety

Sleep Disturbance

Infant Behavior

Maternal Behavior

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Smart Bassinet

HALO

Study Details

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 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

Postpartum Depression

Postpartum Anxiety

Sleep Disturbance

Infant Behavior

Maternal Behavior

Study ID

NCT06544941

Start date

Jan 15, 2025

Status verified date

Aug, 2024

Completion date

Jun, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

342 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Smart Bassinet

The SNOO will respond to a crying or fussing infant in order to soothe and calm it down.

HALO

The HALO is a commercially available bassinet

Primary outcome measure

  • Maternal Mood [ Time Frame: 0-6 months postpartum ]
  • Maternal Sleep [ Time Frame: 0-6 months postpartum ]
  • Infant Sleep [ Time Frame: 0-6 months postpartum ]
  • Maternal Inflammation [ Time Frame: late pregnancy, 3 & 6 months postpartum ]

Central Contacts and Locations

Central contacts

Michele L Okun, Ph.D.

412-302-8030mokun@uccs.edu

Locations

University of Colorado Colorado Springs

Recruiting

Colorado Springs, Colorado, United States, 80918

Contacts

Michele L Okun, Ph.D.

412-302-8030mokun@uccs.edu

Principal Investigator:

Michele L Okun, Ph.D.

More Information

Sponsor

University of Colorado, Colorado Springs

Last update posted

Feb 10, 2025

Last verified

Aug, 2024

Keywords

  • sleep
  • postpartum
  • intervention
  • inflammation
  • depression
  • anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Colorado Springs on 2025-02-10.