Frequen-ZZZ^® is the foundational investigational sleep neuromodulation platform that established the scientific and clinical basis for the development of DeltaWave TVMS designed to support coordinated spinal–autonomic network regulation during sleep.

A randomized, double-blind, sham-controlled crossover clinical study was conducted in collaboration with The Pennsylvania State University to evaluate the safety and physiological effects of FREQUEN-ZZZ. The trial began in July 2023, with final data collection completed on May 10, 2024.

Participants were enrolled based on an Insomnia Severity Index (ISI) score  ≥ 8, targeting individuals with clinically significant sleep disruption. The study was designed to evaluate whether nightly use of FREQUEN-ZZZ^® could improve objective and subjective measures of sleep quality while demonstrating good safety and tolerability