FREQUEN-ZZZ^® is an investigational medical device that implements a proprietary magnetic wave scheme for vagus nerve stimulation that is applied throughout the night, while you sleep, to activate parasympathetic neuronal responses to improve sleep in patients with insomnia. Kunasan Inc sponsored a double-blind, randomized, controlled Proof-of-Concept clinical study with the Pennsylvania State University that commenced in July 2023 with last data collection May 10th, 2024. This study is a double-blind clinical trial, in which bedside controllers for Kunasan’s FREQUEN-ZZZ^® Sleep Pad systems are coded and either “activated” or “deactivated” (sham/control) prior to the clinical site receiving the devices for use in the research. The participants in this study recorded Insomnia Severity Index scores of ≥ 8 at enrollment.