FREQUEN-ZZZ^® is an investigational medical device intended to improve sleep in patients with insomnia. Kunasan Inc sponsored a Proof-of-Concept investigational 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.