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Stimulation mode first for Post-Traumatic Stress Disorder

N/A

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ first week at-home recordings to second week, up to 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Emotional Regulation - arousal

Change in Emotional Regulation - recall

Change in Slow-wave Activity (SWA)

Secondary outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,190 Previous Clinical Trials

3,169,447 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,512 Total Patients Enrolled

Stephanie Jones, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study have an age restriction that excludes individuals under the age of 40?

"The trial is seeking individuals aged above 15 years but below 18 years to participate."

Answered by AI

Are potential candidates able to apply for participation in this ongoing trial?

"As per clinicaltrials.gov, the ongoing medical investigation is not in a phase of patient recruitment. Its initial listing was on April 1st, 2024, with the most recent revision being made on March 26th, 2024. Despite this trial's inactive status for enrollment currently, there are numerous other studies seeking participants; precisely, there are 414 active trials at present actively pursuing eligible patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

2024. "Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06341413.

All > Ptsd