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Phase II Trial of Nu-V3 Non-Invasive Nerve Stimulation Device for Chronic Pain, Anxiety, Depression, Sleeplessness

SuspendedNot applicableNCT05394545
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Conditions
Interventions
  • Device: Nu-V3
Sponsor
Nu-Life Solutions
Start date
2024-03-20
Primary completion
2025-05-31
Sex
All
Age range
from 18 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Participant is at least 18 years of age * Participant presents with one or more of the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness * Participants must score greater than or equal to a 5/10 for their primary symptom score on the Baseline Symptom Questionnaire * Patient's chosen primary symptom must have an available accrual slot for the participant. If patient scores greater than or equal to a 5/10 for a second symptom, they can be selected to accrue to another symptom slot. * Participant has signed the Informed Consent Form Exclusion Criteria: * Participants with a hearing aid * Participants with a pacemaker * Participants with irregular heart rate or a heart rate lower than 60 beats per minute (bradycardia) * Have had a transplant within the last 2 years * Have had a heart attack or cardiac bypass surgery within the last 12 months * Patients with complaints of dizziness or lightheadedness within the last 3 months * Women who are pregnant * Participants with Diabetic Retinopathy * Current ear infection * SBP \< 100 and/or DBP \< 60 * History of uncontrolled bipolar disorder within the last 12 months * History of uncontrolled seizures within the last 12 months * History of aneurysms * History of syncope within the last 12 months * Participants that have had a TIA or stroke within the last 12 months * Participants with health problems deemed at risk for the study by the Principal Investigator * Participants with any changes to Pain/Anxiety/Depression/Sleeplessness medications within last 60 days (participants that do not meet this medication- change washout period may be delayed until 60-day period is met) * Participants that are currently under adjudication process for disability support, VA or other

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05394545