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NCT06655844 · ClinicalTrials.gov registry record · NA
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
A NA study of Chronic Pain and Post-treatment Lyme Disease Syndrome, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06655844: Recruiting NA study of Chronic Pain and Post-treatment Lyme Disease Syndrome, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06655844 is a NA study of Chronic Pain and Post-treatment Lyme Disease Syndrome that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 30 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06655844, a NA study of Chronic Pain and Post-treatment Lyme Disease Syndrome, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full scale from 0-10 with higher score indicating more symptom. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.
Conditions Studied
Interventions
- DEVICE Sana Pain Reliever
- DEVICE Sham SPR
Study Locations (1)
New York
- The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-10-04 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What NCT06655844 shows while recruiting
NCT06655844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which Sana Pain Reliever is the first listed.
NCT06655844 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06655844 about?
NCT06655844 is a clinical study titled "Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain". 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 d...
What is the current status of trial NCT06655844?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-10-04. Estimated completion is 2026-03-31.
What conditions does trial NCT06655844 study?
This clinical trial studies the following conditions: Chronic Pain, Post-treatment Lyme Disease Syndrome.
What interventions are being tested in trial NCT06655844?
The interventions under investigation include: Sana Pain Reliever (DEVICE), Sham SPR (DEVICE).
Who is sponsoring clinical trial NCT06655844?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06655844 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06655844's enrollment target sits among peer trials
30 244th of 301 higher than 48 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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