NCT04280562

Remote Participation (Within USA) Trial of Sana Pain Reliever

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathic Pain
• Chronic Pain
• Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-01-31
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2020-02-21
• Last updated: 2025-11-04
• Results posted: 2025-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study