Trial of Nu-V3, non-invasive nerve stimulation device for chronic pain, anxiety, depression, sleeplessness

The research company Nu-Life Solutions is conducting the clinical trial Nu-V3 Non-Invasive Nerve Stimulation Device for Chronic Pain, Anxiety, Depression, Sleeplessness (Nu-V3P2RCT).

This Nu-V3 clinical study is a randomized, phase II, open-label study evaluating the Nu-V3 cranial nerve stimulation treatment device in patients with chronic pain, anxiety, depression, and/or sleeplessness.

It is planned to include 80 participants.

Actual study start date is June 20, 2022. The researchers expect to complete the study by December 31, 2023.

One primary outcome measure is effectiveness and overall change in reported primary symptom of concern: Sleeplessness, Sleeplessness - PROMIS short form 4a- This eight item instrument measures sleep disturbance and sleep-related impairment. This eight item instrument measures sleep disturbance and sleep-related impairment.

Further details can be found here https://ichgcp.net/clinical-trials-registry/NCT05394545.