Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 4, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Post-treatment Lyme Disease SyndromeChronic Pain
Interventions
DEVICE

Sana Pain Reliever

The Sana Pain Reliever (Sana PR) by Sana Health Inc is a device comprised of one (1) main component (Mask with Earbuds) and two (2) ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears).

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 15 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.

Trial Locations (1)

10029

RECRUITING

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE), New York

All Listed Sponsors
collaborator

Sana Health, Inc.

UNKNOWN

lead

Icahn School of Medicine at Mount Sinai

OTHER