Efficacy of Sana Treatment in Fibromyalgia: A Blinded Randomized Controlled Trial

Sana Health1 site in 1 country166 target enrollmentJuly 14, 2020

ConditionsFibromyalgia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Sana Health
Enrollment: 166
Locations: 1
Primary Endpoint: Change in quality of life as measured by the Revised Fibromyalgia Impact Questionnaire (FIQR).
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research study is to evaluate the effectiveness of an experimental device called the Sana Pain Reliever Device (Sana Device) on treating pain due to fibromyalgia.

Registry

clinicaltrials.gov

Start Date

July 14, 2020

End Date

March 4, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sana Health

Responsible Party

Sponsor

Eligibility Criteria

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.
•Clinical diagnosis of Fibromyalgia given a minimum of 8 weeks prior to Screening.
•Patient must have an average pain severity score of ≥40 and \<90 on the 100-point VAS for the last 72 hours prior to Screening.
•Any analgesic therapy must be at approximately stable levels for at least 14 days prior to enrollment and remain steady throughout the study.
•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 vertigo.
•Diagnosis of cancer or active cancer treatment occurring within the last year.
•Surgery or trauma requiring rehabilitation within the last 12 weeks.
•Vision impairments that affect perception of light, color, or brightness in one or both eyes, and differences in visual perception between eyes, at the discretion of the investigator.
•Deafness in one or both ears, perceived differences in hearing between ears, or tinnitus, at the discretion of the investigator.
•Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion).
•Presence of inflammation or broken skin around the eyes in the area of the mask.
•Presence of narcolepsy or untreated sleep apnea or requiring treatment for sleep apnea such that use of device at bedtime will be interrupted, at discretion of the investigator.

Outcomes

Primary Outcomes

Change in quality of life as measured by the Revised Fibromyalgia Impact Questionnaire (FIQR).

Time Frame: Screening, Baseline, Days 14, 28, 56, 112 and 196.

Scores are measured on a 100 point scale (0-100) with the lower score (0) indicating no difficulty and the higher score indicating very difficult (100). Extreme Fibromyalgia (FM): 75-100, Severe FM: 60-74, Moderate FM: 43-59, Mild FM: 0-42

Change in health system utilization.

Time Frame: Days 28 and 196.

Utilization is self reported via a Health Care Utilization survey.

Secondary Outcomes

Change in pain as measured by the Brief Pain Inventory (BPI).(Screening, Baseline, Days 14, 28, 56, 112 and 196.)
Change in depression as measured by the Patient Health Questionnaire 8 (PHQ-8).(Screening, Baseline, Days 14, 28, 56, 112 and 196.)
Change in anxiety as measured by the Generalized Anxiety Disorder 7 (GAD-7).(Screening, Baseline, Days 14, 28, 56, 112 and 196.)
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI).(Screening, Baseline, Days 14, 28, 56, 112 and 196.)
Change in pain as measured by the Pain Visual Analog Scale (P-VAS).(Daily (Day 0 - 196))