Exploratory analysis
RLS
Exploratory analyses were conducted to determine which components of sleep were improved by active versus sham TOMAC at the end of stage 1. Post-hoc For comparing RLS improvement depending on baseline RLS severity, baseline IRLS scores of 11–20 were considered moderate, 21–30 severe, and 31–40 very severe. Since a minimum IRLS score of 15 was required for study entry, 15–20 was the actual range of moderate baseline symptoms.Participants were asked to rate the duration of RLS symptom relief—if any—that persisted after completion of each 30-minute TOMAC session. Participants were asked to rate this only for TOMAC sessions administered more than 2 h before bedtime, due to the challenges with accurately estimating duration of symptom relief during the sleep period. Multiple choice options ranged from “no relief” after TOMAC to “>2 hours of relief” after TOMAC.Objective exposure to therapy was assessed through analysis of therapy unit device logs which recorded the timing, duration (minutes), and participant-selected intensity (current, mA) for each therapy session. Since participants were instructed to use the device only with RLS symptoms, objective adherence was assessed by comparing daily frequency of completed sessions to daily frequency of RLS symptoms based on responses to IRLS question #7.