FREQUEN-ZZZ^®  is an investigational medical device that employs a proprietary magnetic wave technology for vagus nerve stimulation. Designed for use during sleep, this innovative device activates parasympathetic neuronal responses to enhance sleep quality for patients suffering from insomnia. Kunasan Inc initiated a double-blind, randomized, controlled Proof-of-Concept clinical study in collaboration with Pennsylvania State University, which began in July 2023, with final data collection completed on May 10th, 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