Exploratory analyses
RLS
MOS
To determine which specific components of sleep were improved in response to TOMAC treatment, we conducted exploratory post hoc analysis on each of the items included in the MOS-I and MOS-II at the end of stage 1, using the Holm–Bonferroni method to account for multiple comparisons. TOMAC resulted in statistically significant reductions in MOS item 7 (trouble falling asleep) and MOS item 9 (trouble staying awake during the day) relative to sham control. Change to MOS item 7 was −20.6 points for TOMAC compared to −2.9 points for sham (Difference = −17.8; 95% CI −8.5 to −27.1, We compared RLS improvement at Week 8 for participants with moderate, severe, or very severe baseline symptoms, as defined by IRLS score at study entry. All three subgroups showed substantial improvement. Mean IRLS change at Week 8 was −4.2 points for participants with moderate baseline symptoms (Responders were asked to quantify the duration of RLS symptom reduction after each individual 30-minute TOMAC session. Due to the difficulty of quantifying symptoms while asleep, participants were specifically asked to quantify duration of relief for TOMAC sessions administered more than 2 hours before bedtime. Among CGI-I responders (CGI-I of 1 or 2 at Week 8) who used the device in this context (Satisfaction was high, with 89% of participants reporting they would like to continue treatment and 92% indicating that they would be likely to recommend the treatment to a friend or family member with RLS.