Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06655844
Status
Recruiting
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Conditions

  • Chronic Pain
  • Post-treatment Lyme Disease Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sana Pain Reliever — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 4, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Real Arm
    This group will experience the active device settings.
  • Sham Comparator: Sham Arm
    This group will experience the sham device settings.

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

Locations (1)

FacilityCityStateZIPSite coordinators
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)New YorkNew York10029
David Putrino (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)· New York, NY

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