150 Participants Needed

PEACE Patch for Stress and Anxiety

(STRAVA Trial)

Recruiting in Tyrone (>99 mi)
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: SuperPatch Limited LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to collect subject perceptions or feelings about their treatment. Participation includes a survey from individuals who are receiving a stress or anxiety-relieving topical patch \[Super Patch PEACE Patch with Haptic Vibrotactile Trigger Technology (VTT)\] and assigned to a Treatment Group or given a Sham patch, assigned to the Control Group, to address symptoms or stress and anxiety symptoms using validated scales \[for example, The Perceived Stress Scale (PSS) or Medical Outcomes Study Short Form-20 (SF-20)\].

Who Is on the Research Team?

JG

Jeffrey Gudin, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals experiencing stress or anxiety who are interested in testing a topical patch designed to relieve these symptoms. Participants will be asked to complete surveys about their feelings using validated scales.

Inclusion Criteria

I was given a placebo patch in the study.
Able to provide written informed consent
I received a PEACE Patch from my doctor for treatment.
See 1 more

Exclusion Criteria

Use of drugs of abuse (illicit or prescription)
Pregnancy
Existing or planned implantation of Pacemaker or other electrical devices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the active PEACE Patch with VTT or a sham patch for stress and anxiety relief

2 weeks
Baseline, 7-day, and 14-day visits

Follow-up

Participants are monitored for changes in stress levels and medication usage after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Haptic Vibrotactile Trigger Technology Patch
Trial Overview The study tests the PEACE Patch, which uses Haptic Vibrotactile Trigger Technology, against a sham (placebo) patch. Participants will be randomly assigned to either the treatment group with the real patch or control group with the sham.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: TREATMENTActive Control1 Intervention
Group II: CONTROLPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SuperPatch Limited LLC

Lead Sponsor

Trials
3
Recruited
400+

Clarity Science LLC

Collaborator

Trials
3
Recruited
400+
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