Efficacy of Sana Treatment in Fibromyalgia

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Sana Sham Device


Participation Criteria
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Eligibility Criteria
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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. Participation in any other clinical study in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days. Any pending legal action that could prohibit participation or compliance in the study. Recent history of or current evidence of suicidal ideation or active suicidal behavior, based on medical history, at the discretion of the investigator. Significant medical conditions or other circumstances which, in the opinion of the investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the patient from safely participating in study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel 2-arm study in which patients will be randomly assigned to either active treatment or Sham control arms.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sana Device<br>The Sana Device is an externally worn mask that physically contacts the skin of the face. The Sana Device delivers Audio Visual Stimulation (AVS) in the form of coordinated pulses of light (through closed eyelids) and sound at various frequencies. | Device: Sana Sham Device<br>* Externally worn mask that physically contacts the skin of the face. The Sana Device delivers Audio Visual Stimulation (AVS) in the form of coordinated pulses of light (through closed eyelids) and sound at various frequencies.<br>|
| Sham Comparator: Sana Sham Device<br>The sham treatment device is designed to copy the look and feel of the Sana therapy to a degree that it would be indistinguishable from the true treatment. The sham treatment delivers a series of Audio-Visual Stimulation (AVS) in the form of pulses of light (through closed eyelids) and sound, but that offer no therapeutic effect. | Device: Sana Sham Device<br>* Externally worn mask that physically contacts the skin of the face. The Sana Device delivers Audio Visual Stimulation (AVS) in the form of coordinated pulses of light (through closed eyelids) and sound at various frequencies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life as measured by the Revised Fibromyalgia Impact Questionnaire (FIQR). | 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 | Screening, Baseline, Days 14, 28, 56, 112 and 196. | 
| Change in health system utilization. | Utilization is self reported via a Health Care Utilization survey. | Days 28 and 196. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety as measured by the Generalized Anxiety Disorder 7 (GAD-7). | Seven items are rated from 0 - 3 with a lower score indicating less anxiety and a higher score indicated more anxiety. | Screening, Baseline, Days 14, 28, 56, 112 and 196. | 
| Change in depression as measured by the Patient Health Questionnaire 8 (PHQ-8). | Eight items are rated from 0 - 3 with a lower score indicating less depression and a higher score indicated more depression. | Screening, Baseline, Days 14, 28, 56, 112 and 196. | 
| Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). | Seven component scores are derived from 0 -3. A lower score indicates better sleep quality and a higher score worse sleep quality. | Screening, Baseline, Days 14, 28, 56, 112 and 196. | 
| Change in pain as measured by the Brief Pain Inventory (BPI). | Scores are measured on a 10 point scale with the lower score indicating less interference due to pain and the higher score indicating complete interference. | Screening, Baseline, Days 14, 28, 56, 112 and 196. | 
| Change in pain as measured by the Pain Visual Analog Scale (P-VAS). | Scores are measured on a 100mm VAS. The lower number indicates less pain and the higher number more pain. | Daily (Day 0 - 196) |