Improving Sleep and Quality of Life after Use of a Haptic Vibrotactile Trigger Technology, Drug-Free, Topical Patch: Results from the HARMONI Study

Abstract

Sleep issues are widely prevalent throughout the US and can greatly impact a person’s quality of life while imparting a significant personal and societal burden. Evidence supports the importance of sleep health to overall physical health, behavioral health, wellness, and safety. Several diseases have been identified as having a significant association with sleep disorders and sleep duration, including depression, diabetes, obesity, hypertension, and cardiovascular events. Conventional pharmacological treatments for sleep disorders have been associated with dangerous adverse effects. Identifying effective and safe alternative treatment strategies, including those that are non-invasive and non-pharmacologic and that have reduced and limited side effect profiles, will provide options that may be preferable in how clinicians traditionally treat sleep disorders. There has been research focusing on neuronal pathways and circuits that have been shown to respond to sensory (nociceptive) stimulation. Researchers have shown that these pathways and specific areas of the brain can change in response to external stimuli. Haptic vibrotactile trigger technology (VTT) is designed to target the nociceptive pathways and theorized to disrupt these brain centers. The technology has been incorporated into non-invasive, non-pharmacological topical patches and other routes of delivery. The purpose of this IRB-approved, minimal risk observational study was to evaluate patients’ experiences and/or perceptions and patient response for those who received a haptic vibrotactile trigger technology (VTT) embedded non-pharmacologic, non-invasive, over-the-counter sleep patch (REM Sleep Patch with VTT; Super Patch Company, Srysty Holding Co, Toronto, Canada). Methods: Baseline, 7- and 14-day data were recorded in one hundred thirteen (113) adult subjects (79 females and 34 males) with a mean age of 53 years who presented with sleep- or insomnia- related issues or associated symptoms. The study evaluated changes in overall sleep quality and insomnia severity scores via validated scales (PSQI (Pittsburgh Sleep Quality Index) and the ISI (Insomnia Severity Index)), changes in the use of prescription and OTC medications, patient satisfaction, and any side effects reported while using the patch. Future analysis will compare the outcomes reported here with control and crossover treatment groups. Results: The results showed statistically significant decreases in time to fall asleep, an increase in number of hours of sleep, improvement in the quality of sleep, and reduction in global PSQI Score after using the VTT embedded sleep patch. After 14 days, the vast majority of patients reported a reduction of usage of oral medications, that the patch was convenient and easy to use, and preferred the patch over oral and other medications for sleep. Results also showed positive outcomes in Quality of Life (QoL) components with improvements in daytime fatigue, mood, ability to function at work/daily chores, concentration, memory, and mood. Conclusions: Study results indicate that this non-pharmacologic, non-invasive, haptic vibrotactile trigger technology (VTT) embedded topical patch improves sleep quality, duration, and quality-of-life components and may reduce the use of concurrent medications, including prescribed and other oral medication for adult patients with sleep or insomnia-related symptoms. Results reported suggest that the non-pharmacological topical sleep patch has incredible potential to be added to the current approaches and treatments of noninvasive and nonpharmacological sleep therapies.