Remote Participation (Within USA) Trial of Sana Pain Reliever

October 17, 2023 updated by: David Putrino, Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10011
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "Real" SPR
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
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.
Sham Comparator: Sham SPR
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
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)
Time Frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
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)
Time Frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
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)
Time Frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
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)
Time Frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
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)
Time Frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
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)
Time Frame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
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)
Time Frame: Post-assessment (Week 10); Follow up (Week 14)
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
Time Frame: VAS-Pain: before and after each time they use the device up to 14 weeks

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
Time Frame: VAS-Sleep: once/day up to 14 Weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Sana Health, Inc.

Investigators

  • Principal Investigator: David Putrino, PT, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2020

Primary Completion (Actual)

February 21, 2023

Study Completion (Actual)

February 21, 2023

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 18-2282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Sana Pain Reliever

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe