PEACE Patch for Stress and Anxiety

(STRAVA Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SuperPatch Limited LLC

Must not be taking: Drugs of abuse

Disqualifiers: Pregnancy, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess participants' experiences with a patch designed to relieve stress and anxiety. Participants will receive either a real patch with technology that sends tiny calming vibrations or a placebo patch that does nothing. The goal is to gather feedback on the patch's effectiveness in reducing stress and anxiety. Individuals with stress or anxiety issues who have received either the treatment or sham patch from their doctor might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new stress-relief solutions.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those using drugs of abuse, so you may want to discuss your current medications with the trial team.

What prior data suggests that this patch is safe for stress and anxiety relief?

Research has shown that the Haptic Vibrotactile Trigger Technology (VTT) Patch is generally easy to use. In one study, over 90% of users reported satisfaction after using the patch for 14 days, suggesting positive results without major issues. Other reports indicate that this patch can help reduce anxiety and improve sleep and balance without causing serious side effects. Although studies don't provide specific numbers on negative effects, high satisfaction rates suggest that most users didn't experience significant problems. This patch is non-invasive, meaning it doesn't enter the body, which typically lowers the risk of severe side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PEACE Patch for stress and anxiety because it introduces a novel approach to managing these conditions through haptic vibrotactile trigger technology. Unlike traditional treatments, which might include medications like SSRIs or cognitive-behavioral therapy, the PEACE Patch provides a non-invasive, drug-free alternative. This patch delivers a specific sensory pattern that may help alleviate stress and anxiety, offering a potentially quicker and more accessible option for individuals who struggle with traditional treatments. Its unique delivery method could appeal to those seeking a different way to manage their symptoms without the side effects often associated with medication.

What evidence suggests that the Haptic Vibrotactile Trigger Technology Patch is effective for stress and anxiety?

Research has shown that the Haptic Vibrotactile Trigger Technology (VTT) Patch, which participants in this trial may receive, can help reduce stress and anxiety. In one study, over 90% of people using the patch felt satisfied and noticed improved mental health after just 14 days, suggesting the patch can lower stress levels. Another study found that users had significantly lower stress and anxiety scores, highlighting its potential benefits. Additionally, people have reported better sleep and less anxiety, demonstrating the patch's broader effectiveness. Overall, these findings support the patch's potential to help manage stress and anxiety. Participants in this trial will receive either the active VTT Patch or a sham patch without vibrotactile haptic technology. ^{1 2 3 4 6}

Who Is on the Research Team?

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.

I received a PEACE Patch from my doctor for treatment.

Able to provide written informed consent

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?

Group I: TREATMENT Active Control 1 Intervention

Subjects will be given a patch that incorporates a vibrotactile haptic technology (VTT) sensory pattern (PEACE Patch)

Group II: CONTROL Placebo Group 1 Intervention

Subjects will be given a sham patch that does not incorporate vibrotactile haptic technology.

Who Is Running the Clinical Trial?

SuperPatch Limited LLC

Lead Sponsor

Trials

3

Recruited

400+

Clarity Science LLC

Collaborator

Trials

3

Recruited

400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12488145/

Decreased anxiety through haptic technology patch usage In contrast, there was little change in all PSS and SF-20 scores from baseline to Day 14 for the CG; 97.3% of the CG were not at all satisfied ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06708715

Stress Reduction After Use of a Haptic Vibrotactile Trigger ... Stress Reduction After Use of a Haptic Vibrotactile Trigger Technology Patch: Analysis and Assessment. Conditions. StressAnxiety. StressAnxiety. StressAnxiety.

3. scivisionpub.com scivisionpub.com/pdfs/improvement-of-mental-health-and-anxiety-with-haptic-technology-patch-utilization-interim-results-from-an-exploratory-study-3322.pdf

Improvement of Mental Health and Anxiety with Haptic ... At day 14, over 90% of patients in the treatment group indicated that they were satisfied with the patch and approximately 90% of subjects ...

4. journals.lww.com journals.lww.com/jfmpc/fulltext/2025/08000/decreased_anxiety_through_haptic_technology_patch.61.aspx

Decreased anxiety through haptic technology patch usage Recent research has reported positive outcomes with haptic vibrotactile trigger technology (VTT) for conditions such as insomnia, psychiatric disorders, balance ...

5. researchgate.net researchgate.net/publication/366891576_Haptic_Vibrotactile_Trigger_Technology_Disrupting_the_Neuromatrix_to_Reduce_Pain_Severity_and_Interference_Results_from_the_HARMONI_Study

(PDF) Haptic Vibrotactile Trigger Technology: Disrupting ... Results: After using the VTT embedded stress and anxiety-relieving patch, results showed statistically significant decreases in stress and ...

6. link.springer.com link.springer.com/article/10.1007/s40122-025-00780-0

Reducing Pain and Improving Mobility Using Haptic Patch ... Haptic vibrotactile trigger technology (VTT) is designed to target nociceptive pathways and is theorized to disrupt the neuromatrix of pain. The ...