Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches

Last updated: December 5, 2025
Sponsor: SuperPatch Limited LLC
Overall Status: Active - Enrolling

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Muscle Pain

Treatment

Sham Patch without haptic vibrotactile trigger technology (VTT)

Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:

Clinical Study ID

NCT06505005
RESTORE-001
  • Ages 18-65
  • All Genders

Study Summary

This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive patch (FREEDOM or REM Patch; The Super Patch Company Inc.); using validated scales and functional measurement tools along with crossover and control groups within the same subject group not receiving an 'active' patch.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 18-64

  • Ability to provide Informed Consent

  • Received a study patch (active or sham) from their treating clinician (randomized)for back, shoulder, and other musculoskeletal pain.

  • Has been diagnosed with an acute, moderate pain condition

  • Agrees to wear an adhesive study patch during the study period

Exclusion

Exclusion Criteria:

  • Patients who are beneficiaries of a government-funded healthcare program

  • Use of drugs of abuse (illicit or prescription)

  • Have an implanted device, or wears, or adheres any electrical device to the bodyduring the study, other than a hearing aid.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Sham Patch without haptic vibrotactile trigger technology (VTT)
Phase:
Study Start date:
September 20, 2024
Estimated Completion Date:
May 01, 2026

Study Description

Emerging technologies that use haptic (skin pressure) technology have been studied and have shown positive improvements in stress levels, balance, sleep, and pain. The FREEDOM and REM patch (SuperPatch Company, Toronto, Canada and Florida, USA) that also incorporates this technology has shown promise to improve relieve pain and improve sleep. This IRB-approved, Randomized Controlled Trial (RCT) will measure effectiveness of the pain and sleep patches through assessment of validated scales and functional measurements such as the Brief Pain Inventory (BPI), the Schober Test, the Bubble Inclinometer Measurement, and the Flexion Finger-Floor Measurement for the pain patch, and Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI), and a sleep wearable monitor for the Sleep patch.

Connect with a study center

  • Stein Medical

    Tyrone, Georgia 30290
    United States

    Site Not Available

  • Stein Medical

    Tyrone 4227612, Georgia 4197000 30290
    United States

    Site Not Available

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