Phase II Trial of Nu-V3 Non-Invasive Nerve Stimulation Device for Chronic Pain, Anxiety, Depression, Sleeplessness
SuspendedNot applicableNCT05394545
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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
- Chronic Pain
- Anxiety
- Depression
- Sleeplessness
- 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