Relaxis Clinical Data

The Symphony™ device was the first generation device used in our clinical studies. Relaxis is a second generation device that meets the same product specifications and provides the same vibratory counterstimulation as the first generation device. Relaxis also complies with the latest electrical safety requirements. Relaxis clinical data can be found below, including results from two clinical trials and four articles that resulted from those studies.

Sensory NeuroStimulation performed two randomized controlled clinical trials in a total of 158 patients to assess the safety and effectiveness of vibratory counterstimulation with Relaxis in the treatment of patients with primary RLS. Patient inclusion criteria (moderate to severe RLS) as well as primary and secondary endpoints, as measured with standardized outcome instruments, were identical for both studies. The primary difference between the two studies was the design of the sham device. The first study (SMI-001) used a sound-emitting (auditory) sham in the control group, while the second study (SMI-002) used a light-emitting sham control. Both studies had the same primary and secondary endpoints.

 

Publications

Analysis of the two clinical studies can be found in published articles through the following links to Dove Press.

Part I of this series shows that Relaxis pads are significantly superior to sham pads at improving the quality of sleep in patients with primary RLS. The statistical technique of meta-analysis is used in Part II to show that the degree of subjective sleep improvement from Relaxis therapy is not significantly different than treatment with FDA-approved RLS drugs. Part III demonstrates a strong connection between patient belief about the Relaxis system and its therapeutic effect, supporting the theory that RLS dysphoria originates within the brain and not within the legs themselves. Part IV compares sham pads used in the Relaxis trials with placebo pills used in RLS drug trials and demonstrates that sham pads and placebo pills have comparable effects.

 

"Restless legs syndrome treatment" "Horizant" Horizant gabapentin Horizanr RLS medication Newpro patch Ropinirole dosage JPRLS-40354-sleep-improvement-for-restless-legs-syndrome-patients--part_032813_Page_01"Restless legs syndrome treatment" "Horizant" Horizant gabapentin Horizanr RLS medication Newpro patch Ropinirole dosage JPRLS-40356-sleep-improvement-for-restless-legs-syndrome-patients--part-_032913_Page_01 (1)

 

For Part 1 click here.                  For Part 2 click here.

"Restless legs syndrome treatment" "Horizant" Horizant gabapentin Horizanr RLS medication Newpro patch Ropinirole dosage JPRLS-40358-sleep-improvement-for-restless-legs-syndrome-patients--part-_032913_Page_1x    "Restless legs syndrome treatment" "Horizant" Horizant gabapentin Horizanr RLS medication Newpro patch Ropinirole dosage Relaxis pad JPRLS-55215-sleep-improvement-for-restless-legs-syndrome-patients--part-_022514_Page_1 (1)

 

For Part 3 click here.                   For Part 4 click here.

 

 

SMI-001 Results

Design: This was a prospective, 1:1 randomized, multicenter (five sites) trial which assessed the safety and effectiveness of the Symphony Device in the reduction of symptoms associated with RLS by comparison to an auditory sham control device. Subjects were adults with moderate-to-severe primary RLS involving only the legs, with a minimum baseline score of 15 points on the International Restless Legs Scale (IRLS) scale and symptoms occurring at least 15 nights per month. Patients with secondary RLS, other sleep disorders, disorders involving the legs (e.g., cellulitis or deep vein thrombosis) or taking unapproved medications to treat their RLS were excluded. If subjects were on an approved RLS medication, they were required to be on stable doses during the trial. Patients used the device for at least one 35 minute cycle each night. The primary endpoint was the mean change from baseline in the IRLS total score to week 1, 2, 3 and 4. The safety endpoint was a descriptive analysis of adverse events from both groups. Secondary endpoints included the mean change from baseline to 4 weeks in the Medical Outcomes Study (MOS) Sleep Scale scores and the Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire (RLSQOL). The MOS inventory is a patient-reported questionnaire that evaluates sleep disturbance. The MOS sleep problem index II (MOS-II) contains 9 of the 12 inventory questions and measures sleep difficulty based on recall about sleep quality during the four weeks prior to taking the test.

Results: A total of 77 subjects were enrolled in the study at a 1:1 ratio (39 used Symphony, 38 used the sham device). Although there were no statistically significant differences between active and sham groups for the primary endpoint (IRLS score), there were statistically significant improvements in the mean MOS-II scores (-15.83 for Symphony vs -5.34 for sham, p=0.0230).

Adverse Events (AEs): There were six AEs in the Symphony group (15.4%) that were at least possibly device-related. There were an additional two AEs in the Symphony group and four AEs in the sham group that were not device-related. All device-related AEs resolved after use of the device was stopped, without medical intervention or clinical sequelae. One AE (cramping sensation in both legs) was graded as moderate and all five remaining AEs were graded as mild. The most common AE was worsening of RLS symptoms, which occurred in four subjects with the Symphony device (10.3%). Worsening of RLS symptoms resolved within three weeks of discontinuation of device use.

CR-007_C SMI-001 Results Summary

 

 

SMI-002 Results

Design: This was a prospective, 2:1 randomized, multicenter (four sites) trial which assessed the safety and effectiveness of the Symphony Device in the reduction of symptoms associated with RLS by comparison to a light-emitting sham control device. The inclusion/exclusion criteria, study design, and endpoints were very similar to SMI-001, with only minor differences.

Results: A total of 81 subjects were enrolled in the study at a 2:1 ratio (52 used Symphony, 29 used the sham device). Although there were no statistically significant differences between active and sham groups in any of the primary or secondary endpoints, there were mean improvements in the MOS-II scores (-11.41 for Symphony vs -7.36 for sham, p=0.3040).

Adverse Events: There were five AEs in the Symphony group (9.6%) and two in the sham group (6.9%) that were at least possibly device-related. There were an additional two AEs that were not device-related; both were in the Symphony group. All device-related AEs in the Symphony group were categorized as worsening of RLS symptoms and resolved within three weeks of discontinuation of device use without additional intervention. One of these AEs was graded as moderate and the remaining four were graded as mild. In the sham group, one AE was categorized as worsening of RLS symptoms (mild), which resolved after stopping use of the sham device. The other AE was pain below the knee (moderate), which resolved with use of a heating pad.

Design: This was a prospective, 2:1 randomized, multicenter (four sites) trial which assessed the safety and effectiveness of the Symphony Device in the reduction of symptoms associated with RLS by comparison to a light-emitting sham control device. The inclusion/exclusion criteria, study design, and endpoints were very similar to SMI-001, with only minor differences.

CR-008_C SMI-002 Results Summary