FREQUEN-ZZZ^® is an investigational device utilizing proprietary magnetic wave technology intended to stimulate the vagus nerve during sleep. Engineered to activate parasympathetic neuronal pathways, it aims to support improved sleep quality in individuals experiencing insomnia. A double-blind, randomized, controlled proof-of-concept clinical study was initiated by Kunasan Inc. in collaboration with Pennsylvania State University. The study commenced in July 2023, with final data collection completed on May 10, 2024 This clinical trial maintains a rigorous methodology, with bedside controllers for Kunasan’s FREQUEN-ZZZ^® Sleep Pad systems coded as either “activated” or “deactivated” (sham/control). The devices are prepared and delivered to the clinical site in a blinded format to ensure the integrity of the study. Participants in the trial were enrolled based on an Insomnia Severity Index score of ≥ 8, highlighting the device’s focus on individuals with significant sleep challenges