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Behavioural Intervention
Smart Bassinet for Postpartum Depression (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
Ages 18-45 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up late pregnancy, 3 & 6 months postpartum
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a Smart Bassinet's effectiveness in preventing postpartum mood disorders by improving maternal and infant sleep. The researchers will conduct a study with 342 participants who will be randomly assigned
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 belowSelect...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ late pregnancy, 3 & 6 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~late pregnancy, 3 & 6 months postpartum
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 moreSecondary study objectives
Epigenetic biomarkers at the TTC9B and HP1BP3 genes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
5,037 Total Patients Enrolled
University of VirginiaOTHER
785 Previous Clinical Trials
1,316,104 Total Patients Enrolled
3 Trials studying Inflammation
40 Patients Enrolled for Inflammation
Weill Medical College of Cornell UniversityOTHER
1,092 Previous Clinical Trials
1,154,444 Total Patients Enrolled
8 Trials studying Inflammation
3,846 Patients Enrolled for Inflammation
Michele L OkunPrincipal InvestigatorUniversity of Colorado, Colorado Springs