StressSTRAVANCT06708715
Stress Reduction After Use of a Haptic Vibrotactile Trigger Technology Patch: Analysis and Assessment
A study testing PEACE Patch in people with Stress and Anxiety, run by SuperPatch Limited LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- PEACE Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 85, inclusive
- Able to provide written informed consent
- Have received a PEACE Patch from their treating clinician if in treatment group.
- Is a patient who has been diagnosed with experienced stress or anxiety related issues.
- Have received a Sham Patch if assigned tot eh Control Group
Who cannot join
- Use of drugs of abuse (illicit or prescription)
- Pregnancy
- Existing or planned implantation of Pacemaker or other electrical devices
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- PEACE Patch, Topical Sham Patch
- Keywords
- stress, anxiety, SuperPatch, PEACE Patch, Haptic, Vibrotactile Haptic Technology, VTT
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEACE PatchDevice
A topical patch that incorporates a sensory pattern of vibrotactile haptic technology.
Topical Sham PatchDevice
Sham Patch that does not include vibrotactile haptic technology
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT | Active comparator | Subjects will be given a patch that incorporates a vibrotactile haptic technology (VTT) sensory pattern (PEACE Patch) Receives: Device: PEACE Patch |
| CONTROL | Sham comparator | Subjects will be given a sham patch that does not incorporate vibrotactile haptic technology. Receives: Device: Topical Sham Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to end of treatment at 2 weeks
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.
Measured: From enrollment to end of treatment at 2 weeks
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.
Measured: From enrollment to end of treatment at 2 weeks
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.
Measured: From enrollment to end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start5 May 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SuperPatch Limited LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clarity Science LLC
- Responsible party
- Sponsor
- Investigators
- Jeffrey Gudin, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708715
- Sponsor's protocol ID
- STRAVA-001
- Acronym
- STRAVA
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction After Use of a Haptic Vibrotactile Trigger Technology Patch: Analysis and Assessment
- ClinicalTrials.gov ID
- NCT06708715
- Acronym / sponsor ID
- STRAVA / STRAVA-001
- Keywords
- stress, anxiety, SuperPatch, PEACE Patch, Haptic, Vibrotactile Haptic Technology, VTT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SuperPatch Limited LLCIndustry (pharma, biotech, devices)
- Collaborators
- Clarity Science LLC
- Study start
- 5 May 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)].
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TREATMENT | Active comparator | Device: PEACE PatchSubjects will be given a patch that incorporates a vibrotactile haptic technology (VTT) sensory pattern (PEACE Patch) |
| CONTROL | Sham comparator | Device: Topical Sham PatchSubjects will be given a sham patch that does not incorporate vibrotactile haptic technology. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18 to 85, inclusive
- Able to provide written informed consent
- Have received a PEACE Patch from their treating clinician if in treatment group.
- Is a patient who has been diagnosed with experienced stress or anxiety related issues.
- Have received a Sham Patch if assigned tot eh Control Group
Key exclusion criteria (3 listed)
- Use of drugs of abuse (illicit or prescription)
- Pregnancy
- Existing or planned implantation of Pacemaker or other electrical devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEACE PatchA topical patch that incorporates a sensory pattern of vibrotactile haptic technology. | Device | TREATMENT |
| Topical Sham PatchSham Patch that does not include vibrotactile haptic technology | Device | CONTROL |
Primary outcome
Changes in patient Perceived Stress Scale (PSS)
Time frame: From enrollment to end of treatment at 2 weeks
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).
Changes in patient Medical Outcomes Study Short Form-20 (SF-20)
Time frame: From enrollment to end of treatment at 2 weeks
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.
Changes in the use of prescription and OTC medications
Time frame: From enrollment to end of treatment at 2 weeks
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.
Demographics and patient satisfaction with the PEACE Patch treatment.
Time frame: From enrollment to end of treatment at 2 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Gudin, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEACE Patch in people with Stress and Anxiety, run by SuperPatch Limited LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patient Perceived Stress Scale (PSS) (time frame: From enrollment to end of treatment at 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.