FibromyalgiaNCT04568798
Efficacy of Sana Treatment in Fibromyalgia
A study of Fibromyalgia, run by Sana Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2020to 4 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Sana Sham Device
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sana Sham DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sana Device | Active comparator | 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. Receives: Device: Sana Sham Device |
| Sana Sham Device | Sham comparator | 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. Receives: Device: Sana Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Screening, Baseline, Days 14, 28, 56, 112 and 196.
Change in health system utilization.
Utilization is self reported via a Health Care Utilization survey.
Measured: Days 28 and 196.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily (Day 0 - 196)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start14 Jul 2020
- Primary completion30 Oct 2021
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel 2-arm study in which patients will be randomly assigned to either active treatment or Sham control arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Scott Kollins, Ph.D, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568798
- Sponsor's protocol ID
- Pro00105695
- Status last verified
- Mar 2022
- First submitted
- 23 Sep 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sana Treatment in Fibromyalgia: A Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04568798
- Acronym / sponsor ID
- Pro00105695
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Sana HealthIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel 2-arm study in which patients will be randomly assigned to either active treatment or Sham control arms.
| Arm | Type | Receives |
|---|---|---|
| Sana Device | Active comparator | Device: Sana Sham DeviceThe 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. |
| Sana Sham Device | Sham comparator | Device: Sana Sham DeviceThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sana Sham DeviceExternally 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 Device, Sana Sham Device |
Primary outcome
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.
5 secondary outcomes
Change in anxiety as measured by the Generalized Anxiety Disorder 7 (GAD-7).
Time frame: 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.
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI).
Time frame: 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.
Change in pain as measured by the Pain Visual Analog Scale (P-VAS).
Time frame: Daily (Day 0 - 196)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Kollins, Ph.D principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fibromyalgia, run by Sana Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.