Clinical trial NCT04568798: Efficacy of Sana Treatment in Fibromyalgia
Official title: Efficacy of Sana Treatment in Fibromyalgia: A Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Sana Health
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2020-09-29
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel 2-arm study in which patients will be randomly assigned to either active treatment or Sham control arms.
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Change in quality of life as measured by the Revised Fibromyalgia Impact Questionnaire (FIQR).
timeFrame: Screening, Baseline, Days 14, 28, 56, 112 and 196.
measure: Change in health system utilization.
timeFrame: Days 28 and 196.
Secondary outcomes:
measure: Change in anxiety as measured by the Generalized Anxiety Disorder 7 (GAD-7).
timeFrame: Screening, Baseline, Days 14, 28, 56, 112 and 196.
measure: Change in depression as measured by the Patient Health Questionnaire 8 (PHQ-8).
timeFrame: Screening, Baseline, Days 14, 28, 56, 112 and 196.
measure: Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI).
timeFrame: Screening, Baseline, Days 14, 28, 56, 112 and 196.
measure: Change in pain as measured by the Brief Pain Inventory (BPI).
timeFrame: Screening, Baseline, Days 14, 28, 56, 112 and 196.
measure: Change in pain as measured by the Pain Visual Analog Scale (P-VAS).
timeFrame: Daily (Day 0 - 196)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Scott Kollins, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: