Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505005
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Relieving Pain and Improving Sleep Evaluating Topical Pain Relief and Sleep Patches
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RESTORE Relieving Pain and Improving Sleep Evaluating Topical Pain Relief and Sleep Patches to Optimize Effectiveness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE
Brief Summary:
This minimal risk randomized double-blind placebo controlled Institutional Review Board IRB-approved observational 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None