Remote Participation (Within USA) Trial of Sana Pain Reliever

  • STATUS
    Recruiting
  • End date
    Feb 12, 2023
  • participants needed
    100
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 12 May 2022
pain reliever
neuralgia

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.

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.

Details
Condition Neuropathic Pain, Chronic Pain, Pain
Treatment Sana Pain Reliever, Sham SPR
Clinical Study IdentifierNCT04280562
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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