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
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Overall safety from unanticipated problems or risks
研究概览
简要总结
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.
详细描述
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 symptoms: chronic pain, anxiety, depression, and/or sleeplessness, as well as their quality of life, active medications, medical history, and demographical information. The subject's primary symptom of concern will also be notated at baseline, for later assessment of continuation after week 12.
- At each subsequent visit, patients will be asked to complete study questionnaires regarding all the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness, as well as their activity level and quality of life.
- The sessions will begin with the Nu-V3 device being clipped on the ear and three small pads (non-invasive) adhered to the surface of the ear. Each Nu-V3 device lasts for up to 28 days with a change in the pads approximately 7 days into the treatment.
- Each session takes approximately 15-20 minutes. The placement of the device takes approximately 5 minutes, and the remaining time is spent verifying ePRO form completion, and evaluating the patient for all device effects.
- The Nu-V3 device is mobile and is worn externally on the left ear 24 hours a day during treatment, fitting comfortably behind the ear. An electrical signal is sent to the external ear through coated wire leads attached to the device and adhesive pads which attach to three sites on the ear.
- Participants should be able to perform their typical day-to-day activities while wearing the device. They may shower while wearing the Nu-V3 device, if they do not get the device wet and use the small disposable ear covers that are provided for them.
- In the event the Nu-V3 gel pads are inadvertently removed or the device comes off, the participant will contact the site coordinator. The participant is encouraged to adjust the device placement as needed for comfort.
- Patients should not change their existing forms of treatment or medications without discussion with the study investigator.
Subjects randomized to the observation control arm of the study will undergo the following regimen:
- At the baseline visit, patients will be asked to complete study questionnaires regarding all the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness, as well as their quality of life, active medications, medical history, and demographical information. The subject's primary symptom of concern will also be notated at baseline.
- At each subsequent visit, patients will be asked to complete study questionnaires regarding all the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness, as well as their activity level and quality of life.
- Patients should not change their existing forms of treatment or medications without discussion with the study investigator.
- At completion of 12 weeks of standard of care treatment post study enrollment, observation (control arm) subjects will be offered a crossover into the treatment arm of the study for an additional 24 weeks.
Sample size For this Phase II study, a total of 100-200 subjects will be randomized 1:1 to either the Nu-V3 treatment arm or to the observation treatment arm (SOC, control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall safety from unanticipated problems or risks
时间窗: Week 24
At screening/baseline, a medical history will be obtained to capture relevant underlying conditions. The screening/baseline examinations will include BP, and HR. Baseline signs and symptoms are those that are assessed within 14 days prior to week 1 treatment. Concomitant medications will be collected from within 14 days prior to enrollment through the study treatment period and maintenance period. The primary safety endpoint is the occurrence of reported unanticipated problems involving risk to subjects or others ("UPIRTSOs"). These UPIRTSOs are defined as those problems which alter the risks to subjects or others. This includes any study suspensions or holds. The primary safety endpoint analyses will be based on a risk-benefit conclusion.
Effectiveness and overall change in reported primary symptom of concern: Anxiety
时间窗: 12 and 24 weeks
Anxiety - (GAD-7)The GAD-7 is a seven-item instrument that measures respondents' symptoms of anxiety. The GAD-7 is a seven-item instrument that measures respondents' symptoms of anxiety. Each item is scored on a four-point Likert scale, and values range from 0 ("Not at all") to 3 ("Nearly every day".) Items are summed to determine the instrument's score. Values of 10 or higher have been associated with moderate anxiety, while values of 15 or higher have been associated with severe anxiety.
Effectiveness and overall change in reported primary symptom of concern: Depression
时间窗: 12 and 24 weeks
Depression - (PHQ-9) The PHQ-9 is a nine-item instrument that measures depression-related symptoms and functional impairment. The PHQ-9 is a nine-item instrument that measures depression-related symptoms and functional impairment. Each item is scored on a four-point Likert scale and values range from 0 ("Not bothered at all") to 3 ("Bothered nearly every day.") The items' values are summed to determine the instrument's score. PHQ-9 values of 10 and 15 represent moderate and moderately severe depression respectively.
Effectiveness and overall change in reported primary symptom of concern: Chronic Pain
时间窗: 12 and 24 weeks
Chronic Pain - (PEG Scale) The PEG is a three-item instrument that measures pain intensity (one item) and pain interference (two items). The PEG is a three-item instrument that measures pain intensity (one item) and pain interference (two items). Each item is valued from 0 (no pain/interference) to 10 (as bad as you can imagine). The instrument score is calculated as the average of the three item values.
Effectiveness and overall change in reported primary symptom of concern: Sleeplessness
时间窗: 12 and 24 weeks
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.
次要结局
- Effectiveness: Symptom Frequency(12 and 24 weeks)
- Effectiveness: Symptom Severity(12 and 24 weeks)