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

NCT ID: NCT06708715

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2026-05-01

Brief 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)].

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.

Conditions

Stress; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TREATMENT

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

Group Type: ACTIVE_COMPARATOR

PEACE Patch

Intervention Type: DEVICE

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

CONTROL

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

Group Type: SHAM_COMPARATOR

Topical Sham Patch

Intervention Type: DEVICE

Sham Patch that does not include vibrotactile haptic technology

Interventions

PEACE Patch

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

Intervention Type: DEVICE

Topical Sham Patch

Sham Patch that does not include vibrotactile haptic technology

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Ages 18 to 85, inclusive

2. Able to provide written informed consent

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

1. Use of drugs of abuse (illicit or prescription)

2. Pregnancy

3. Existing or planned implantation of Pacemaker or other electrical devices

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clarity Science LLC

UNKNOWN

Sponsor Role: collaborator

SuperPatch Limited LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Gudin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Stein Medical

Tyrone, Georgia, United States

Countries

United States

Other Identifiers

STRAVA-001

Identifier Type: -

Identifier Source: org_study_id