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SmartSleep Device for Adolescent PTSD

N/A
Recruiting
Led By Stephanie Jones, MD, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first week at-home recordings to second week, up to 6 weeks
Awards & highlights

Summary

This trial aims to understand how sleep quality, emotions, and daily mood affect PTSD in young people. Participants will have 4 study visits, including assessments, cognitive tests, surveys, and sleep studies with

Who is the study for?
This trial is for adolescents who have PTSD. They must be able to attend four study visits, including assessments, cognitive tests, surveys, an MRI scan, and two overnight sleep studies after a week of at-home sleep recordings.
What is being tested?
The trial is testing the SmartSleep device's ability to enhance slow wave activity during sleep. The aim is to see if better sleep quality can improve how these youths feel the next day.
What are the potential side effects?
Since this trial involves a non-invasive device aimed at improving sleep quality without medication, side effects are expected to be minimal but may include discomfort from wearing the device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first week at-home recordings to second week, up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and first week at-home recordings to second week, up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Emotional Regulation - arousal
Change in Emotional Regulation - recall
Change in Slow-wave Activity (SWA)
Secondary study objectives
Change in Positive and Negative Affect Schedule (PANAS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stimulation mode firstExperimental Treatment1 Intervention
During one week, the SmartSleep device will be set to stimulation mode.
Group II: Sham mode firstPlacebo Group1 Intervention
During one week, the SmartSleep device will be set to sham.

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Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,210 Previous Clinical Trials
3,157,559 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,356 Total Patients Enrolled
Stephanie Jones, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
~0 spots leftby Oct 2024
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