Recruiting

Sana DeviceSana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06655844

Conditions

Post-treatment Lyme Disease Syndrome

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sana Pain Reliever

Sham SPR

Study Details

Brief 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

Post-treatment Lyme Disease Syndrome

Chronic Pain

Study ID

NCT06655844

Start date

Oct 4, 2024

Status verified date

Apr, 2026

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Confirmed clinical diagnosis of neuropathic pain AND
Confirmed clinical diagnosis of Post-treatment Lyme disease syndrome
Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:

Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition
Erythema Migrans
History of possible exposure to a high incidence county or state (or an adjacent area)
Erythema migrans rash

EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)
EM 1A: MOA self-report \& medical record documentation of rash > 5 cm
EM 1B: MOA: self-report and medical record documentation of EM rash but not size
EM 1C: MOA: self-report \& rash misdiagnosed in medical record as cellulitis/spider bite
EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR Disseminated "objective" manifestation with lab test confirmation of Bb infection
Clinical history includes at least one of the following symptoms/signs, which are not better accounted for by another cause (MOA: medical records and/or self-report).
Neurologic: Lymphocytic Meningitis; Encephalitis; Encephalomyelitis, Cranial Neuritis (especially facial palsy); Radiculoneuropathy;
Other Neurologic Signs (with objective measures): Encephalopathy, Polyneuropathy
Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis
Lyme arthritis: Recurrent joint swelling in one or more joints
Dermatologic: Disseminated EM ("satellite") or Acrodermatitis atrophicans AND
Lab test Confirmation (previous) (requires at least one of the Class 1 lab tests) (MOA: self-report \& documentation) Group 2. Probable.
Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation
Class 1 lab test confirmation (excluding IgM WB)
Highly suggestive IgG WB (4 of 10 bands) OR EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR
Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard twotiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report)
Ages 18+
Fluent in English
Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)

Exclusion Criteria:

Diagnosis of photosensitive epilepsy
Ear or eye infection
Vision impairments that affect perception of light in one or both eyes
Deafness in one or both ears
Psychiatric disorders (participants will not be excluded if they score 0-30 points on the BDI, or if participants self- report having anxiety)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Real Arm

This group will experience the active device settings.

sham comparator: Sham Arm

This group will experience the sham device settings.

Interventions

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).

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.

Primary outcome measure

Neuropathic Pain Symptom Inventory [ Time Frame: Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) ]

Central Contacts and Locations

Central contacts

Laura Tabacof, MD

212-241-8454 CoreResearch@mountsinai.org

Locations

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

Recruiting

New York, New York, United States, 10029

Contacts

CoreResearch@mountsinai.com

Principal Investigator:

David Putrino

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 18, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-18.