Improving Maternal Sleep and Mental Health
NCT Number: NCT06544941
Acronym: SHINE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postpartum Depression|Postpartum Anxiety|Sleep Disturbance|Infant Behavior|Maternal Behavior|Inflammation|Military Family
Interventions: DEVICE: Smart Bassinet|DEVICE: HALO
Sponsor: University of Colorado, Colorado Springs
Collaborators: University of Virginia|Weill Medical College of Cornell University
Sex: FEMALE
Age: ADULT
Enrollment: 342
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-15
Completion Date: 2028-06
Locations: University of Colorado Colorado Springs, Colorado Springs, Colorado, 80918, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Epigenetic biomarkers at the TTC9B and HP1BP3 genes, Evaluate whether the elevated risk previously demonstrated can be modified by using a SB., assess markers at Baseline (Late pregnancy)