Improving Maternal Sleep and Mental Health

NCT06544941 | Recruiting FDA Device

• 1 other identifier: HT94252410690
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

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; Inflammation; Military Family

Keywords

sleep; postpartum; intervention; inflammation; depression; anxiety

Outcome Measures

Primary Outcomes (4)

• Maternal Mood

  Assessment of depressive and anxiety symptoms across the first 6 months postpartum

  0-6 months postpartum

• Maternal Sleep

  Assessment of sleep across the first 6 months postpartum

  0-6 months postpartum

• Infant Sleep

  Assessment of infant sleep across the first 6 months postpartum

  0-6 months postpartum

• Maternal Inflammation

  Assessment of changes in maternal inflammation

  late pregnancy, 3 & 6 months postpartum

Secondary Outcomes (1)

• Epigenetic biomarkers at the TTC9B and HP1BP3 genes

  assess markers at Baseline (Late pregnancy)

Study Arms (2)

Smart Bassinet (SB)

EXPERIMENTAL

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.

Device: Smart Bassinet

HALO Bassinet (TAU)

ACTIVE COMPARATOR

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

Device: HALO

Interventions

Smart Bassinet DEVICE

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

Also known as: Robotic, responsive bassinet, SNOO

Smart Bassinet (SB)

HALO DEVICE

The HALO is a commercially available bassinet

HALO Bassinet (TAU)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Colorado Springs: lead
• University of Virginia: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

University of Colorado Colorado Springs

Colorado Springs, Colorado, 80918, United States

RECRUITING

Related Publications (1)

• Okun ML, Payne JL, Osborne LM, Feliciano L, Lac A. Effects of Using a Smart Bassinet on the Mental Health of Military-Affiliated Pregnant Women: Protocol for a Randomized Controlled Sleep Health and Mood in Newly Expectant Military Mothers (SHINE) Trial. JMIR Res Protoc. 2025 Apr 10;14:e66439. doi: 10.2196/66439.

  PMID: 40209215 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Parasomnias; Infant Behavior; Inflammation; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Child Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms

Study Officials

• Michele L Okun

  University of Colorado, Colorado Springs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele L Okun, Ph.D.

CONTACT

412-302-8030; mokun@uccs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women are randomized to one of two bassinets to use for up to 6 months PP

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)