Impact of transdermal trigeminal electrical neuromodulation on subjective and objective sleep parameters in patients with insomnia: a pilot study

Purpose Transcutaneous trigeminal electrical neuromodulation (TTEN) is a new treatment modality that has a potential to improve sleep through the suppression of noradrenergic activity. This study aimed to explore the changes of subjective and objective sleep parameters after 4-weeks of daily session of transcutaneous trigeminal electrical neuromodulation in a group of patients with insomnia. Methods In a group of patients with insomnia, TTEN targeting the ophthalmic division of the trigeminal nerve was utilized to test the effects of transcutaneous trigeminal electrical neuromodulation. Patients went through daily 20-min sessions of TTEN for 4 weeks. Polysomnography parameters, Pittsburgh sleep quality index, insomnia severity index, and Epworth sleepiness scale were obtained pre- and post-intervention. Changes in these parameters were compared and analyzed. Results Among 13 patients with insomnia there was a statistically significant reduction in Pittsburgh sleep quality index, insomnia severity index, and Epworth sleepiness scale scores after 4-week daily sessions of TTEN. There were no differences in polysomnography parameters pre- and post-intervention. Conclusion This is the first study to demonstrate the effects of TTEN in a group of insomnia patients. TTEN may improve subjective parameters in patients with insomnia. Further replication studies are needed to support this finding. Trial registration The data presented in the study are from a study exploring the effect of TTEN on insomnia ( www.clinicaltrials.gov , registration number: NCT04838067, date of registration: April 8, 2021, "retrospectively registered").