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Behavioural Intervention

Smart Bassinet (SB) for Sleep Disorder (SHINE Trial)

N/A
Waitlist Available
Led By Michele L Okun
Research Sponsored by University of Colorado, Colorado Springs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Pregnant women with a singleton gestation who have a military affiliation
* Ages 18-45 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up late pregnancy, 3 & 6 months postpartum
Awards & highlights

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.

Who is the study for?
This trial is for military-affiliated pregnant women in the US. Participants should be willing to use a smart bassinet or traditional bassinet, complete monthly questionnaires, and allow sleep data collection from both mother and baby. Blood samples will also be taken at specified times postpartum.
What is being tested?
The study tests if a Smart Bassinet can improve infant and maternal sleep, thereby reducing postpartum depression and anxiety symptoms. It's a randomized controlled trial comparing the Smart Bassinet with a standard one over six months.
What are the potential side effects?
There are no direct side effects mentioned for using the Smart Bassinet or standard bassinet; however, participation involves regular questionnaires, wearing an actigraph to monitor sleep, and providing blood samples.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~late pregnancy, 3 & 6 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and late pregnancy, 3 & 6 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Infant Sleep
Maternal Inflammation
Maternal Mood
+1 more
Secondary study objectives
Epigenetic biomarkers at the TTC9B and HP1BP3 genes

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Smart Bassinet (SB)Experimental Treatment1 Intervention
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.
Group II: HALO Bassinet (TAU)Active Control1 Intervention
The HALO is a commercially available bassinet that does not have any robotic/responsive actions incorporated within it.

Find a Location

Who is running the clinical trial?

University of Colorado, Colorado SpringsLead Sponsor
18 Previous Clinical Trials
5,029 Total Patients Enrolled
University of VirginiaOTHER
766 Previous Clinical Trials
1,284,833 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,072 Previous Clinical Trials
1,320,486 Total Patients Enrolled
~228 spots leftby Aug 2027