ClinicalTrials.gg
Active, not recruitingNCT06708715STRAVAUpdated Aug 20, 2026

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

An interventional study of PEACE Patch and Topical Sham Patch in Stress and Anxiety, sponsored by SuperPatch Limited LLC. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by SuperPatch Limited LLC · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled May 2023, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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)].

Read the detailed description

This minimal risk observational study, will evaluate an over the counter (OTC) non-invasive, non- pharmacological patch (Super Patch PEACE Patch; The Super Patch Company Ltd LLC., SRYSTY Holding Co., Toronto, Canada) that is embedded with a proprietary sensory pattern and incorporates haptic vibrotactile trigger technology (VTT) and designed to trigger neural pathways and circuits associated with stress, anxiety, and other cortical networks, with other study participants who receive an 'inactive' (Sham) patch without the embedded VTT technology. The sensory patterns within the active patches are in close symmetry between known EEG patterns and their role in modulating EEG and neuronal circuits within higher brain centers.

02

Conditions studied

  • Stress
  • Anxiety

Browse trials for

Keywords

  • stress
  • anxiety
  • SuperPatch
  • PEACE Patch
  • Haptic
  • Vibrotactile Haptic Technology
  • VTT
03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

SuperPatch Limited LLC is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ages 18 to 85, inclusive
  2. Able to provide written
  3. Have received a PEACE Patch from their treating clinician if in treatment group.
  4. Is a patient who has been diagnosed with experienced stress or anxiety related issues.
  5. Have received a Sham Patch if assigned tot eh Control Group

Exclusion criteria

Exclusion Criteria:

  1. Use of drugs of abuse (illicit or prescription)
  2. Pregnancy
  3. Existing or planned implantation of Pacemaker or other electrical devices
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    TREATMENT

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

    Device: PEACE Patch

  • Sham comparator
    CONTROL

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

    Device: Topical Sham Patch

Interventions

  • DevicePEACE Patch

    A topical patch that incorporates a sensory pattern of vibrotactile haptic technology.

  • DeviceTopical Sham Patch

    Sham Patch that does not include vibrotactile haptic technology

06

What researchers measure

Primary outcomes

  1. Changes in patient Perceived Stress Scale (PSS)

    Changes in patient Perceived Stress Scale (PSS) overall scores among and between the treated group and the control group. The Perceived Stress Scale (PSS) score is calculated by adding the score for all 10 questions, after reversing the scores for Q4, 5, 7 and 8 (0=4, 1=3, 2=2, 3=1, 4=0). Total possible score = 40. PSS categorizes stress levels as either high (scores of between 27-40), moderate (scores between 14-26), or low (scores between 0-14).

    Time frame: From enrollment to end of treatment at 2 weeks

  2. Changes in patient Medical Outcomes Study Short Form-20 (SF-20)

    Changes in patient Medical Outcomes Study Short Form-20 (SF-20) for 6 domains among and between the treated group and the control group. There are 20 items and 6 domains in the SF-20 that are measured. These are Physical Functioning, Role Functioning, Social Functioning, Mental Health, Health Perceptions, and Pain. Except for the Pain domain, the higher the percentage, the better the quality-of-life is corresponding. For the Pain domain, the lower the percentage, the lower the amount of bodily pain is corresponding. For the Mental Health domain, the analysis represents the four major mental health dimensions. These are anxiety, depression, loss of behavioral-emotional control, and psychological well- being.

    Time frame: From enrollment to end of treatment at 2 weeks

  3. Changes in the use of prescription and OTC medications

    Changes in Number of Prescription Medications Used based on subject and clinician reporting through a questionnaire for those subjects in Treatment Arm and receiving the active patch (PEACE) or Control Sham patch during study period. Comparisons will be made between prescription medication usage reporting at baseline, 7-day, and 14 days.

    Time frame: From enrollment to end of treatment at 2 weeks

  4. Demographics and patient satisfaction with the PEACE Patch treatment.

    Demographics and patient satisfaction based on subject and clinician reporting for those subjects in Treatment Arm and receiving the active patch (PEACE) or Control Sham patch during study period.

    Time frame: From enrollment to end of treatment at 2 weeks

Other outcomes

  1. Any side effects reported by patients will be documented and assessed by clinician and PI

    Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator.

    Time frame: From enrollment to end of treatment at 2 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Aug 2026, 39 months after the start.

Of 102 industry-sponsored interventional studies with no phase under Anxiety Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 39 months is above that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2024
First posted
Nov 27, 2024
StartActual
May 5, 2023
Primary completionEst.
Aug 30, 2026
CompletionEst.
Aug 30, 2026
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06708715
Collaborators
Clarity Science LLC
Responsible party
Sponsor
First posted
Nov 27, 2024
Start date
May 5, 2023
Primary completion
Aug 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Aug 20, 2026

Study contacts

Jeffrey Gudin, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion