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Electrical Stimulation for Sleep and Emotional Health
N/A
Recruiting
Led By Giulio Tononi, 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
Adults aged 18-50 years
Be between 18 and 65 years old
Must not have
Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc)
History of head trauma resulting in prolonged loss of consciousness; or a history of >3 grade 1 concussions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post nap (up to 90 minutes)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using electrical stimulation on the brain during naps can boost brain activity during sleep and potentially improve emotional health and stress resilience. Participants will visit the clinic up to 3 times
Who is the study for?
This trial is for healthy, English-speaking adults aged 18-50 who are regular nappers and either citizens or permanent residents. It's not suitable for those with a history of significant head trauma, neurological disorders, metal in the body, seizures, certain medical conditions or devices, dental implants with metal, claustrophobia, night-shift workers, back issues preventing lying flat or unstable medical conditions.
What is being tested?
The study tests if brain stimulation using Transcranial electrical stimulation with Temporal Interference (TES-TI) during naps can enhance sleep-related brain activity and improve emotional health and stress resilience. Participants will have up to three visits involving wearing an hdEEG cap while taking a nap.
What are the potential side effects?
Potential side effects may include discomfort from wearing the hdEEG cap or skin irritation at electrode sites. Since TES-TI is non-invasive and uses low currents, serious side effects are unlikely but could involve unexpected changes in brain activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any health conditions that could lead to a medical emergency if I had a seizure.
Select...
I have had a severe head injury or more than 3 mild concussions.
Select...
I suffer from severe headaches or migraines that are hard to control.
Select...
I have no history of neurological disorders or brain injuries.
Select...
I cannot lie flat for up to two hours due to back problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post nap (up to 90 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post nap (up to 90 minutes)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in emotion response
Change in minutes scored as REM sleep
Change in sawtooth waves after effective TES-TI intervention
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stimulation followed by no stimulationExperimental Treatment1 Intervention
Phase 2 participants will receive stimulation during their nap at the first visit, and no stimulation during their nap at the second visit.
Group II: No stimulation followed by stimulationExperimental Treatment1 Intervention
Phase 2 participants will not receive stimulation during their nap at the first visit, and receive stimulation during their nap at the second visit.
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,228 Previous Clinical Trials
3,198,483 Total Patients Enrolled
United States Department of DefenseFED
908 Previous Clinical Trials
333,625 Total Patients Enrolled
Giulio Tononi, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
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