NCT06505005

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

RESTORE (Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches to Optimize Effectiveness)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: SuperPatch Limited LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pain, Back
• Pain, Acute
• Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep
• Sleep Deprivation
• Insomnia

Interventions

Type	Name	Description
DEVICE	Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:	Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT)
DEVICE	Sham Patch without haptic vibrotactile trigger technology (VTT)	Sham Patch without haptic vibrotactile trigger technology (VTT)

Timeline

• Start date: 2024-09-20
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-07-17
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States