Actively Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-11-12
30
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
S
Sana Health, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed clinical diagnosis of neuropathic pain
- Confirmed clinical diagnosis of Post-treatment Lyme disease syndrome
- Diagnosis based on meeting 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 with erythema migrans or history of exposure to high incidence area
- Erythema migrans rash diagnosed by healthcare provider or documented by self-report and medical records
- Clinical history of neurological, cardiac, arthritis, or dermatologic symptoms consistent with Lyme disease
- Lab test confirmation with Class 1 lab tests or probable diagnosis with positive lab results
- Ages 18 years and older
- Fluent in English
- Stable medications for at least 4 weeks prior to first baseline visit
You will not qualify if you...
- Diagnosis of photosensitive epilepsy
- Ear or eye infection
- Vision impairments affecting perception of light in one or both eyes
- Deafness in one or both ears
- Psychiatric disorders unless scoring 0-30 points on the Beck Depression Inventory or self-reporting anxiety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States, 10029
Actively Recruiting
Research Team
L
Laura Tabacof, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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