Wearable Neurotechnology for the Treatment of Insomnia: The Study Protocol of a Prospective, Placebo-Controlled, Double-Blind, Crossover Clinical Trial of a Transcranial Electrical Stimulation Device

Sleep disruption and deprivation are epidemic problems in the United States, even among those without a clinically diagnosed sleep disorder. Military service members demonstrate an increased risk of insomnia, which doubles after deployment. This study will investigate the ability of a translational device, Teledyne PeakSleep™ (Teledyne Scientific & Imaging, Durham, NC, USA), to reduce sleep onset latency and the time spent awake after sleep onset, with improvement in the subjective benefits of sleep for patients with insomnia by enhancing the brain rhythms within the frontal lobe implicated in slow wave generation. During this crossover trial, patients will use the wearable neurotechnology prototype headband, which delivers < 14 min of frontal short duration repetitive-transcranial electrical stimulation over a 30 min period immediately before trying to fall asleep. Using active stimulation versus a sham paradigm, we will compare actigraphy data, physiological data, and subjective sleep measures against a pre-treatment baseline in the same patient over the course of the 8-week study. If successful, PeakSleep™ could address the final common pathway in insomnia, namely the onset and maintenance of slow-wave sleep (SWS), and accordingly has the potential to enhance sleep onset in a wide range of individuals, most importantly warfighters in whom efficient sleep onset may be critical for operational success.