- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04568798
Efficacy of Sana Treatment in Fibromyalgia
March 29, 2022 updated by: Sana Health
Efficacy of Sana Treatment in Fibromyalgia: A Blinded Randomized Controlled Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
166
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Screening, Baseline, Days 14, 28, 56, 112 and 196.
|
Change in health system utilization.
Time Frame: Days 28 and 196.
|
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).
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.
|
Screening, Baseline, Days 14, 28, 56, 112 and 196.
|
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.
|
Screening, Baseline, Days 14, 28, 56, 112 and 196.
|
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.
|
Screening, Baseline, Days 14, 28, 56, 112 and 196.
|
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.
|
Screening, Baseline, Days 14, 28, 56, 112 and 196.
|
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.
|
Daily (Day 0 - 196)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott Kollins, Ph.D, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 14, 2020
Primary Completion (ACTUAL)
October 30, 2021
Study Completion (ACTUAL)
March 4, 2022
Study Registration Dates
First Submitted
September 23, 2020
First Submitted That Met QC Criteria
September 28, 2020
First Posted (ACTUAL)
September 29, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00105695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibromyalgia
-
University of AberdeenCompletedFibromyalgia | Fibromyalgia, Primary | Fibromyalgia, SecondaryUnited Kingdom
-
Eli Lilly and CompanyCompletedFibromyalgia, Primary | Fibromyalgia, SecondaryMexico
-
Rasmia ElgoharyNot yet recruiting
-
Tel-Aviv Sourasky Medical CenterCompletedFibromyalgia (FM)Israel
-
Yousra Hisham Abdel FattahCompletedFibromyalgia, PrimaryEgypt
-
Forest LaboratoriesCypress Bioscience, Inc.TerminatedPrimary FibromyalgiaUnited States
-
Universidade Federal do Rio Grande do NorteCompleted
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
University of ManitobaCompleted
Clinical Trials on Sana Sham Device
-
Sana HealthUniversity of PennsylvaniaNot yet recruitingQuality of Life | Fibromyalgia | Pain, Chronic
-
Sana HealthRalph H. Johnson VA Medical CenterCompletedPost Traumatic Stress DisorderUnited States
-
Stanford UniversityPatient-Centered Outcomes Research Institute; San Mateo Medical CenterRecruiting
-
University of California, DavisCompleted
-
Palo Alto Medical FoundationUniversity of Pittsburgh; University of Illinois at Chicago; RTI International; Agency for Healthcare Research and Quality (AHRQ) and other collaboratorsCompletedInsulin Resistance | Prediabetic State | Metabolic Syndrome X
-
Medical University of South CarolinaCompletedUse of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)Upper Respiratory InfectionUnited States
-
Neurolief Ltd.Terminated
-
Neurolief Ltd.Completed
-
University of Toledo Health Science CampusTerminatedVenous Wound UlcersUnited States
-
Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium