Status:
TERMINATED
Nu-V3 Non-Invasive Nerve Stimulation Device Trial for Chronic Pain, Anxiety, Depression, Sleeplessness
Lead Sponsor:
Nu-Life Solutions
Conditions:
Chronic Pain
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Nu-V3 Clinical Study is a prospective, single-arm, open-label, multi-center study using the Nu-V3 cranial nerve stimulation treatment device in patients with chronic pain, anxiety, depression, and...
Detailed Description
Subjects enrolled onto the Nu-V3 Clinical Trial will undergo the following regimen: * At the baseline visit, patients will be asked to complete study questionnaires regarding all of the following sym...
Eligibility Criteria
Inclusion
- Participant is at least 18 years of age
- Participant presents with one or more of the following symptoms: pain, depression, anxiety, and/or sleeplessness
- Participant is capable of understanding the use and maintenance of the device
- Participant is capable and agreeing to participate in the ongoing assessment
- Participant has signed the Informed Consent Form
- Participant can commit to follow all protocol study timepoints
Exclusion
- 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
- History of substance abuse, including prescription drugs, 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 :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05335980
Start Date
April 13 2018
End Date
December 31 2020
Last Update
April 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Endocrinology
Phoenix, Arizona, United States, 85053