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Abstract Introduction Tonic motor activation (TOMAC) is a noninvasive medical device therapy that has been shown to reduce symptoms of refractory restless legs syndrome (RLS). Here, we evaluated the effects of TOMAC on subjective sleep quality. Methods One hundred and thirty-three adults with primary moderate-severe refractory RLS were 1:1 randomized to TOMAC or sham control for 4 weeks. Participants were instructed to self-administer a 30-minute TOMAC session bilaterally over the head of the fibula to electrically stimulate the peroneal nerve whenever RLS symptoms presented. Sleep quality was assessed through prespecified analysis of changes to Medical Outcomes Study Sleep Scale (MOS-Sleep) Sleep Problems Index I (MOS-I) and II (MOS-II) scores from baseline to Week 4. Post hoc t-tests were conducted on each MOS-Sleep item included in the MOS-I or MOS-II. Results MOS-I score changed by -11.8 points (48.5 to 36.7) for TOMAC and -2.8 points for sham (44.5 to 41.7), a difference of -9.0 points (p< 0.001). MOS-II score changed by -13.7 points (52.5 to 38.9) for TOMAC and -4.0 points for sham (48.3 to 44.3), a difference of -9.7 points (p< 0.001), which exceeds the proposed minimal clinically important difference (MCID) of 6 points. Post hoc analysis demonstrated statistically significant reductions in trouble falling asleep (item #7; -34.0% for TOMAC vs. -5.8% for sham; p< 0.01) and trouble staying awake during the day (item #9; -33.6% for TOMAC vs. -2.1% for sham; p< 0.05), which exceeded the standard MCID threshold of 30% relative to baseline. Conclusion For adults with refractory RLS, TOMAC improved subjective sleep quality, sleep latency, and daytime somnolence relative to sham control. Each of these improvements represented clinically important improvements. These data demonstrate that TOMAC can provide meaningful improvements to sleep quality and daytime functioning for patients with refractory RLS. Support (if any) Funding was provided by Noctrix Health, Inc.

Excessive sleepiness (ES) is a frequent symptom of obstructive sleep apnea (OSA) and persists in some patients despite primary OSA therapy and can adversely impact health-related quality-of-life (HRQoL). JZP-110 is a selective dopamine norepinephrine reuptake inhibitor with wake-promoting effects. The efficacy and safety of JZP-110 for the treatment of ES in OSA were evaluated in a phase 3 study for patients with OSA. This also included measures of health-related quality-of-life (HRQoL) as pre-specified secondary endpoints. Eligibility criteria in this study included: OSA diagnosis according to International Classification of Sleep Disorders-3 criteria; past or present use of a primary OSA therapy; Epworth Sleepiness Scale score ≥10; mean sleep latency <30 minutes on the first 4 trials of a 5-trial, 40-minute Maintenance of Wakefulness Test; and usual nightly sleep time ≥6 hours. Patients were randomized (1:1:2:2:2) to JZP-110 37.5mg, 75mg, 150mg, or 300mg, or placebo for 12 weeks, stratified by adherent or non-adherent use of a primary OSA therapy. HRQoL was assessed as changes from baseline to week 12 using the 36-Item Short Form Health Survey version 2 (SF-36v2) and the 5-dimension, 5-level EuroQoL questionnaire (EQ-5D-5L). Safety and tolerability were also evaluated. Complete enrollment of this trial occurred in September 2016. Preliminary data from 427 (of the 476 randomized) patients were 62.1% male, 74.9% white, and a mean±SD age of 54.2 ± 10.6 years. At baseline, the Clinical Global Impression of Severity showed that 41.5%, 33.3%, 12.2%, and 2.8% of patients were moderately, markedly, severely, and extremely ill, respectively. All patients have completed participation in the study and data are being analyzed; complete HRQoL and safety results will be available and reported. Complete data on the effects of JZP-110 on the SF-36v2 and EQ-5D-5L HRQoL measures and safety information will be reported at the time of presentation. Jazz Pharmaceuticals

This article describes an experimental alternative to months-long systems redesigns. In one meeting, the global furniture retailer, IKEA, applying the principle of “whole system in the room,” created a new structure and process for product design, manufacture, and distribution, decentralizing an agglomeration of “silos” that no longer served. Some 52 stakeholders examined the existing system, developed a new design, created a strategic plan and formed task forces led by key executives to implement it. In 18 hours, the plan was developed and signed off on by the company president and key people from all affected functions, with active support from several customers. Was this idiosyncratic to IKEA or repeatable anywhere? The authors hypothesize that oneway to change a system in real time is for those with critical stakes in it to share what they knowunder conditions that enable action without asking permission from anyone not present.