Abstract Background Sleep disturbances are prevalent and linked to adverse neurological outcomes. While conventional transcranial magnetic stimulation (TMS) shows promise, protocols typically require high intensities and prolonged courses. ExoTMS is a novel technology targeting cortical regions involved in sleep regulation. Aim To evaluate ExoTMS efficacy in improving subjective sleep quality in individuals with sleep disturbances. Methods In this multicenter, single-blinded, sham-controlled study, 43 adults were assigned to an active ( n = 31, 70% motor threshold (MT)) or a sham ( n = 12, 5% MT) group. Subjects underwent six sessions targeting the left dorsolateral prefrontal cortex (dlPFC). Outcomes were assessed at baseline and a 3-month follow-up via Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10), Sleep and Stress Assessment, Subject Satisfaction Questionnaire, and Therapy Comfort Questionnaire. Results At baseline, active subjects demonstrated poor sleep (average PSQI 9.7 ± 3.4). At 3 months, the active group showed a significant reduction (-4.7 points, p < 0.0001), with 48.3% of subjects achieving the minimal clinically important difference and 55.2% reaching clinical remission. Active stimulation was particularly effective in reducing sleep onset latency by 46.3 min in subjects with prolonged baseline latency. Additionally, 82.1% of active subjects reported improved stress coping, compared to 63.6% in the sham group. ExoTMS treatment was well tolerated, with all subjects reporting “0” on the Numerical Analog Pain Scale. Conclusion These findings suggest that ExoTMS may represent a promising and well-tolerated non-invasive intervention for improving sleep quality. Trial registration NCT07027657 (ClinicalTrials.gov), registered on June 11, 2025.
Nanos et al. (Thu,) studied this question.