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Effectiveness of the Sana Device on Fibromyalgia Symptoms

NCT05394610 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-04-24

No results posted yet for this study

Summary

This is study designed to confirm the effectiveness of the Sana Device in patients with pain due to fibromyalgia on quality of life as measured by the Fibromyalgia Impact Questionnaire Revised (FIQR). It is a two arm study in which subjects will be randomly assigned to either active device group or sham-controlled group.

Conditions

  • Fibromyalgia
  • Pain, Chronic
  • Quality of Life

Interventions

DEVICE

Sana Device

Audio Visual Stimulation patterns intended to produce a therapeutic benefit.

DRUG

Sana Device (Control)

A control device that mimics the physcial appearance of the Sana device.

Sponsors & Collaborators

Principal Investigators

  • Martin Cheatle, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-12-31
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394610 on ClinicalTrials.gov