NCT06544941 Improving Maternal Sleep and Mental Health
| NCT ID | NCT06544941 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Colorado Springs |
| Condition | Postpartum Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 342 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 342 participants in total. It began in 2025-01-15 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Michele L Okun
PRINCIPAL INVESTIGATOR
University of Colorado, Colorado Springs
Frequently Asked Questions
Who can join the NCT06544941 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Postpartum Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06544941 currently recruiting?
Yes, NCT06544941 is actively recruiting participants. Contact the research team at mokun@uccs.edu for enrollment information.
Where is the NCT06544941 trial being conducted?
This trial is being conducted at Colorado Springs, United States.
Who is sponsoring the NCT06544941 clinical trial?
NCT06544941 is sponsored by University of Colorado, Colorado Springs. The principal investigator is Michele L Okun at University of Colorado, Colorado Springs. The trial plans to enroll 342 participants.
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