Remote Participation (Within USA) Trial of Sana Pain Reliever

Study Overview
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Brief Summary
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Randomized controlled trial to assess the effectiveness and patient perception of the benefit of the Sana Pain Reliever in individuals with chronic neuropathic pain.The study is fully remote with four study visits taking place over teleconferencing and the study devices mailed to the participants to use at home for 8-14 weeks.

Detailed Description
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Chronic neuropathic pain (NP) is an extremely debilitating condition with few treatment options and many of which with multiple side effects. This will be a randomized, sham-controlled trial that will investigate the effectiveness of a novel wearable device called the Sana Pain Reliever (Sana PR) at reducing chronic neuropathic pain. The Sana PR is a device comprised of a Mask to be worn over the eyes with a pair of ear buds to be worn in ears. It displays light and sounds in a predetermined algorithm which runs for 16 minutes at a time. The underlying mechanism of action for the Sana PR is Audio Visual Stimulation (AVS), a form of non-pharmacological intervention that induces a brain wave response called Frequency Following Response (FFR), which has been used for both performance enhancement and symptom management. The device will be used with a compatible tablet application that will collect data from each session that the device is used. This data will be collected through user inputs of responses to several questionnaires. This will be an at-home trial and participants will be loaned the Sana Pain Reliever device and a tablet device to run the application for the duration of the study. The trial will last a total of 14 weeks and will involve four study visits, either in-person at the Abilities Research Center at Mount Sinai Hospital in New York City, or remotely using a video call. The trial includes two baseline sessions on weeks 0 and 2, 8 weeks of the at-home intervention, and post-intervention sessions at the end of weeks 10 and 14. Participants will be instructed to use the device at the end of the day prior to going to sleep as well as whenever they experience greater than typical pain during the day . Data during the at home portion of the trial will be recorded daily via the application. The application will also prompt participants to answer fortnightly weekly questionnaires and send out compliance reminders. Additionally, a series of pain, sleep and quality of life assessments will be completed by participants at both baseline visits, a post-intervention visit and a 4-week follow-up visit.

Official Title
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Extended Home-use Trial of a Novel Device to Reduce Chronic Neuropathic Pain

Conditions
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Pain, Neuropathic Pain, Chronic Pain

Intervention / Treatment
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* Device: Sana Pain Reliever
* Device: Sham SPR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed clinical diagnosis of neuropathic pain Age of 18 years or older at time of consent Fluent in English Consistent medications for the last 4 weeks prior to the first baseline visit (week 0) Exclusion Criteria: Diagnosis of photosensitive epilepsy Active ear or eye infection Vision impairments that affect perception of light in one or both eyes Deafness in one or both ears Severe depression (Score higher than 30 points on the Beck's Depression Inventory)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, randomized, sham-controlled trial parallel arm study that will assess the effectiveness and patient perception of the benefit of the Sana Pain Reliever in individuals with chronic neuropathic pain.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real SPR<br>Participants will receive the device which will run the real Sana Pain Reliever (SPR) protocol and a tablet with a mobile application to record pain levels and other questionnaires | Device: Sana Pain Reliever<br>* Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 16 minutes and run under the device's normal settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.<br>|
| Sham Comparator: Sham SPR<br>Participants will receive the device which will run a sham SPR protocol and a tablet with a mobile application to record pain levels and other questionnaires | Device: Sham SPR<br>* Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 16 minutes and run under the device's sham settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neuropathic Pain Symptom Inventory (NPSI) | This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full scale from 0-10 with higher score indicating more symptom. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline. | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient health Questionnaire Type 9 for Depression (PHQ-9) | The Questionnaire Type 9 for Depression (PHQ-9) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day). It has been validated for use in primary care and is used to monitor the severity of depression and response to treatment. Full scale from 0-27, with higher score indicating more severe symptoms. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline. | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 
| Change in Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates poor from good sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Full score from 0-21, with higher score indicating worse sleep quality. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline. | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 
| Change in Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is used to evaluate depression symptoms, which are estimated to be highly prevalent in chronic pain populations. This questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Depression may be a major contributor to a lack of reduction of pain. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline. | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 
| Change in General Anxiety Disorder 7-item questionnaire (GAD-7) | The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from 0 (not at all) to 3 (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline. | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 
| Change in World Health Organization Quality of Life Pain (WHOQOL-pain) | World Health Organization Quality of Life BREF(WHOQOL-BREF) & World Health Organization Quality of Life Pain (WHOQOL-pain): The WOQOL-BREF is a used to produce a quality of life profile for an individual that is derived from four domains. There are 26 questions which ask users to respond to quality of life (Q.o.L) questions on a scale of 1-5 (1-Not at All, Very Poor, or Very Dissatisfied; 5- Completely, Very Good, or Very Satisfied). The WHOQOL-pain scale is to be used in addition to the WHOQOL-BREF which a specific focus on the impact of pain on Q.o.L. The WHOQOL-pain has 22 items on the pain and discomfort module (PDM) and the importance of items within a user's daily life. Full scale from 0-100 with higher score indicating higher quality of life. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline. | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 
| Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | World Health Organization Quality of Life BREF(WHOQOL-BREF) & World Health Organization Quality of Life Pain (WHOQOL-pain): The WHOQOL-BREF is a used to produce a quality of life profile for an individual that is derived from four domains. There are 26 questions which ask users to respond to quality of life (Q.o.L) questions on a scale of 1-5 (1-Not at All, Very Poor, or Very Dissatisfied; 5- Completely, Very Good, or Very Satisfied). The WHOQOL-pain scale is to be used in addition to the WHOQOL-BREF which a specific focus on the impact of pain on Q.o.L. The WHOQOL-pain has 22 items on the pain and discomfort module (PDM) and the importance of items within a user's daily life. Full scale from 0-100 with higher score indicating higher quality of life. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline. | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | 
| Change in Patient's Global Impression of Change (PGIC) | The Patient's Global Impression of Change (PGIC) will be used to assess self-reported relieving effect. It will evaluate pain from no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7). The patients will answer the following question: Since beginning treatment at this program, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life related to your condition?. Full score from 0-7, with higher score indicating more improvement. Change in score at Week 14 as compared to Week 10. | Post-assessment (Week 10); Follow up (Week 14) | 
| Visual analogue scale (VAS)-Pain | Visual Analog Scale (VAS) to measure pain: a measure of no pain to Worst pain imaginable along a line. Participants will be asked to mark the level of their pain along the line. Visual Analog Scale (VAS) to measure sleep: a measure of did not sleep at all to best possible night's sleep along a line. Participants will be asked to mark the level of their sleep along the line. The Sana Health application will prompt users to answer this scale before they use the device for the first time each day. Full scale from 0-10 with higher score indicating more pain. | VAS-Pain: before and after each time they use the device up to 14 weeks | 
| Visual analogue scale (VAS)-Sleep | Visual Analog Scale (VAS) to measure pain: a measure of no pain to Worst pain imaginable along a line. Participants will be asked to mark the level of their pain along the line. Visual Analog Scale (VAS) to measure sleep: a measure of did not sleep at all to best possible night's sleep along a line. Participants will be asked to mark the level of their sleep along the line. The Sana Health application will prompt users to answer this scale before they use the device for the first time each day. Full scale from 0-10 with higher score indicating more pain. | VAS-Sleep: once/day up to 14 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Neuropathic pain, Wearable devices, Pain management, Neuromodulation