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

ENROLLING BY INVITATION

NCT06505005

NA

Sponsor: SuperPatch Limited LLC

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-09-20

Completion Date

2026-05-01

Last Updated

2025-12-08

Healthy Volunteers

No

Conditions

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

Interventions

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)

Locations (1)

Stein Medical

Tyrone, Georgia, United States

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