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NCT06544941 · ClinicalTrials.gov registry record · NA
Improving Maternal Sleep and Mental Health
A NA study of Inflammation and Sleep Disturbance, sponsored by University of Colorado, Colorado Springs.
- Recruiting
- Registry status
- NA
- Development phase
- 342
- Enrollment target
- 1
- Study location
NCT06544941 is a NA study of Inflammation and Sleep Disturbance that is actively recruiting participants, run by University of Colorado, Colorado Springs. The registered enrollment target is 342 participants, above the 286-participant average among 132 other Inflammation trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06544941, a NA study of Inflammation and Sleep Disturbance, is actively recruiting participants, sponsored by University of Colorado, Colorado Springs.
- RECRUITING
- Registry status
- NA
- Development phase
- 342 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE Smart Bassinet
- DEVICE HALO
Study Locations (1)
Colorado
- University of Colorado Colorado Springs - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Start Date | 2025-01-15 |
| Est. Completion | 2028-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06544941
The ClinicalTrials.gov registry entry for NCT06544941 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 342 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 286-participant average among 132 other Inflammation trials with a reported enrollment target (20% higher). The listed sponsor is University of Colorado, Colorado Springs, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Inflammation appearing as the primary indexed condition, and to 2 interventions - of which Smart Bassinet is the first listed.
NCT06544941 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT06544941 about?
NCT06544941 is a clinical study titled "Improving Maternal Sleep and Mental Health". 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 ...
What is the current status of trial NCT06544941?
This trial is currently recruiting. It is a NA study. The enrollment target is 342 participants. The study started on 2025-01-15. Estimated completion is 2028-06.
What conditions does trial NCT06544941 study?
This clinical trial studies the following conditions: Inflammation, Sleep Disturbance, Postpartum Depression, Maternal Behavior, Postpartum Anxiety.
What interventions are being tested in trial NCT06544941?
The interventions under investigation include: Smart Bassinet (DEVICE), HALO (DEVICE).
Who is sponsoring clinical trial NCT06544941?
This trial is sponsored by University of Colorado, Colorado Springs, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06544941 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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