Clinical trial NCT04280562: Remote Participation (Within USA) Trial of Sana Pain Reliever
Official title: Extended Home-use Trial of a Novel Device to Reduce Chronic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Chronic Pain
Pain
Keywords: Neuropathic pain
Pain
Wearable devices
Pain management
Neuromodulation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Sana Health, Inc.
First posted: 2020-02-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
Secondary outcomes:
measure: Change in Patient health Questionnaire Type 9 for Depression (PHQ-9)
timeFrame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: Change in Beck Depression Inventory (BDI)
timeFrame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: Change in General Anxiety Disorder 7-item questionnaire (GAD-7)
timeFrame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: Change in World Health Organization Quality of Life Pain (WHOQOL-pain)
timeFrame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: Change in World Health Organization Quality of Life Bref (WHOQOL-BREF)
timeFrame: Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: Change in Patient's Global Impression of Change (PGIC)
timeFrame: Post-assessment (Week 10); Follow up (Week 14)
measure: Visual analogue scale (VAS)-Pain
timeFrame: VAS-Pain: before and after each time they use the device up to 14 weeks
measure: Visual analogue scale (VAS)-Sleep
timeFrame: VAS-Sleep: once/day up to 14 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: