Efficacy of Sana Treatment in Fibromyalgia

• ClinicalTrials.gov Identifier: NCT04568798
• Recruitment Status: Completed
• First Posted: September 29, 2020
• Last Update Posted: March 31, 2022
• Sponsor: Sana Health
• Collaborator: Duke University
• Information provided by (Responsible Party): Sana Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Device: Sana Sham Device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel 2-arm study in which patients will be randomly assigned to either active treatment or Sham control arms.
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Sana Treatment in Fibromyalgia: A Blinded Randomized Controlled Trial
• Actual Study Start Date: July 14, 2020
• Actual Primary Completion Date: October 30, 2021
• Actual Study Completion Date: March 4, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sana Device; 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; 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.
Sham Comparator: Sana Sham Device; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. 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

2. Change in health system utilization. [ Time Frame: Days 28 and 196. ]
   Utilization is self reported via a Health Care Utilization survey.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Sana Health

Duke University

Investigators

• Principal Investigator: Scott Kollins, Ph.D; Duke University

More Information

• Responsible Party: Sana Health
• ClinicalTrials.gov Identifier: NCT04568798
• Other Study ID Numbers: Pro00105695
• First Posted: September 29, 2020
• Last Update Posted: March 31, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases