Status:
SUSPENDED
Phase II Trial of Nu-V3 Non-Invasive Nerve Stimulation Device for Chronic Pain, Anxiety, Depression, Sleeplessness
Lead Sponsor:
Nu-Life Solutions
Conditions:
Chronic Pain
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 sleeple...
Detailed Description
Subjects randomized to receive the Nu-V3 treatment will undergo the following regimen: * At the baseline visit, patients will be asked to complete study questionnaires regarding all of the following ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05394545
Start Date
March 20 2024
End Date
May 31 2025
Last Update
July 28 2023
Active Locations (2)
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1
Greater Chicago Specialty Physicians (GCSP) - Schamuburg
Schaumburg, Illinois, United States, 60195
2
EZ Clinic
Greenwood, Indiana, United States, 46143