Effectiveness of the Sana Device on Fibromyalgia Symptoms (NCT05394610) | Clinical Trial Compass
WithdrawnNot Applicable
Effectiveness of the Sana Device on Fibromyalgia Symptoms
Stopped: Study cancelled
0Started 2025-12
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing to and capable of providing written informed consent prior to the conduct of any study-related procedures.
* Male or female, 18 to 65 years of age, inclusive.
* Have a history of experiencing fibromyalgia - like symptoms for a minimum of 36 months (3 years) prior to Screening.
* Subject must be in good physical health based on physical exams, vitals, and/or self-reporting. For subjects where there may not be sufficient recent medical records to document general good health the participant will be asked to self-report at the investigator's discretion.
* Any analgesic medications and medication dosages must be at approximately stable levels for at least 8 weeks prior to enrollment and remain steady throughout the study.
* A total score on the Generalized Anxiety Disorder 7-item scale (GAD-7) of 5 or above.
* A total score on the Patient Health Questionnaire 8-item (PHQ-8) of 5 or above.
* A total score on the STOP-Bang questionnaire of 3 or below.
* Willing and able to comply with the study requirements, complete study assessments, and participate at scheduled times for the duration of the Treatment Phase.
* Able to understand, speak and read English sufficient for the completion of study assessments.
Exclusion Criteria:
* Pregnant or lactating females as self-reported.
* History or presence of photo-sensitive epilepsy or other photo-sensitive conditions.
* History or presence of condition(s) that may affect balance, such as seizure disorders or…