Effects of ExoTMS stimulation on sleep quality: a sham-controlled study

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.