Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
Qualifiers
Confirmed clinical diagnosis of neuropathic pain AND
Confirmed clinical diagnosis of Post-treatment Lyme disease syndrome
Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition
Erythema Migrans
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sana Pain Reliever
- Sham SPR
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
Sana Health, Inc.
Collaborator
Source ClinicalTrials.gov