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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 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.

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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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2024-10-04
Est. Completion 2026-03-31
Phase NA

What the Registry Record Tells You About NCT06655844

The ClinicalTrials.gov registry entry for NCT06655844 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (96% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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