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Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

NCT06655844 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-18

No results posted yet for this study

Summary

This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain.

The Sana PR is a device comprised of one main component (Mask with Earbuds) and two ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies throughout a specific firmware algorithm. Through the earbuds, the device also plays different tones in conjunction with the pulses. The device has a skin contacting Heart Rate Variability (HRV) sensor built into the forehead area that measures HRV throughout the use of the device.

The system runs for 15 min at a time and is not FDA approved.

The trial will last a total of 14 weeks.

50 participants who have a diagnosis of Post-treatment Lyme Disease and experience chronic pain are expected to take part in this study at Mount Sinai.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • David Putrino, PT, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655844 on ClinicalTrials.gov