FibromyalgiaNCT05394610
Effectiveness of the Sana Device on Fibromyalgia Symptoms
A study testing Sana Device in people with Fibromyalgia and Pain, Chronic, run by Sana Health.
Trial summary
This is study designed to confirm the effectiveness of the Sana Device in patients with pain due to fibromyalgia on quality of life as measured by the Fibromyalgia Impact Questionnaire Revised (FIQR). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Pain, Chronic, Quality of Life
- What is being tested?
- Sana Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2027
- 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.
- Have a history of experiencing fibromyalgia - like symptoms for a minimum of 36 months (3 years) prior to Screening.
- Subject must be in good physical health based on physical exams, vitals, and/or self-reporting. For subjects where there may not be sufficient recent medical records to document general good health the participant will be asked to self-report at the investigator's discretion.
- Any analgesic medications and medication dosages must be at approximately stable levels for at least 8 weeks prior to enrollment and remain steady throughout the study.
- A total score on the Generalized Anxiety Disorder 7-item scale (GAD-7) of 5 or above.
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- A total score on the Patient Health Questionnaire 8-item (PHQ-8) of 5 or above.
- A total score on the STOP-Bang questionnaire of 3 or below.
- 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.
- History of presence of condition (s) that meet the criteria for major depressive disorder (MDD), bipolar disorder, or any other personality disorders, at the discretion of the investigator.
- Presence of cancer pain, acute pain following injury or other severe pain not primarily associated with fibromyalgia, at discretion of the investigator.
- Surgery or trauma requiring rehabilitation within the last 12 weeks.
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- Vision impairments that affect perception of light, color, or brightness in one or both eyes, and differences in visual perception between eyes.
- Deafness in one or both ears, perceived differences in hearing between ears, or tinnitus.
- 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.
- At the 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 subject from safely participating in study.
- Employment by the investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the investigator or study site, or a family member of an employee or of the investigator.
About this study
Official title: A Confirmatory Investigation of the Effectiveness of Sana Treatment in Fibromyalgia
This is study designed to confirm the effectiveness of the Sana Device in patients with pain due to fibromyalgia on quality of life as measured by the Fibromyalgia Impact Questionnaire Revised (FIQR). It is a two arm study in which subjects will be randomly assigned to either active device group or sham-controlled group.
- Conditions
- Fibromyalgia, Pain, Chronic, Quality of Life
- Being tested
- Sana Device, Sana Device (Control)
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sana DeviceDevice
Audio Visual Stimulation patterns intended to produce a therapeutic benefit.
Sana Device (Control)Drug
A control device that mimics the physcial appearance of the Sana device.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | 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. The device is externally communicating only. The Sana Device will be administered at least twice daily, with one treatment session being just prior to bedtime. Additional PRN sessions with the Sana device will be allowed at the subject's discretion. Receives: Device: Sana Device |
| Sham Arm | Sham comparator | The sham treatment device was 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 ound but should offer no therapeutic effect to the level of the Sana Device. The sham device will run on the same headset, use a matched intensity of light/audio and used on the same schedule as the Sana treatment. Receives: Drug: Sana Device (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fibromyalgia Symptoms
To confirm the superiority of the active arm over sham on changes in quality of life as measured by the Fibromyalgia Impact Questionnaire Revised (FIQR)
Measured: 6 weeks
Secondary outcomes (5)
Changes in Generalized Anxiety Symptoms
To confirm the superiority of the active arm over sham on generalized anxiety as measured by Generalized Anxiety Disorder 7-item (GAD-7)
Measured: 6 weeks
Changes in Depression Symptoms
To confirm the superiority of the active arm over sham on depression sypmtoms as measured by the Patient Health Questionnaire-8 (PHQ-8)
Measured: 6 weeks
Changes in Sleep Quality
To confirm superiority of the active arm over sham on sleep quality as measured by the PROMIS 4a Sleep Disturbance Scale (PR4A)
Measured: 6 weeks
Changes in Pain
To confirm the superiority of the active arm over sham on reduction of pain as measured by the Pain Enjoyment General-Activity (PEG) scale
Measured: 6 weeks
Perceived Change in Quality of Life
To examine the effect of the active arm on perceived change in quality of life as measured by the Patient Global Impression of Change (PGIC) scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: Study cancelled
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
- Double blind sham contolled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Martin Cheatle, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394610
- Sponsor's protocol ID
- 850524
- Status last verified
- Apr 2026
- First submitted
- 23 May 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Investigation of the Effectiveness of Sana Treatment in Fibromyalgia
- ClinicalTrials.gov ID
- NCT05394610
- Acronym / sponsor ID
- 850524
- Conditions
- Fibromyalgia, Pain, Chronic, Quality of Life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sana HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 May 2022 (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.
This is study designed to confirm the effectiveness of the Sana Device in patients with pain due to fibromyalgia on quality of life as measured by the Fibromyalgia Impact Questionnaire Revised (FIQR). It is a two arm study in which subjects will be randomly assigned to either active device group or sham-controlled group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind sham contolled
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: Sana 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. The device is externally communicating only. The Sana Device will be administered at least twice daily, with one treatment session being just prior to bedtime. Additional PRN sessions with the Sana device will be allowed at the subject's discretion. |
| Sham Arm | Sham comparator | Drug: Sana Device (Control)The sham treatment device was 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 ound but should offer no therapeutic effect to the level of the Sana Device. The sham device will run on the same headset, use a matched intensity of light/audio and used on the same schedule as the Sana treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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.
- Have a history of experiencing fibromyalgia - like symptoms for a minimum of 36 months (3 years) prior to Screening.
- Subject must be in good physical health based on physical exams, vitals, and/or self-reporting. For subjects where there may not be sufficient recent medical records to document general good health the participant will be asked to self-report at the investigator's discretion.
- Any analgesic medications and medication dosages must be at approximately stable levels for at least 8 weeks prior to enrollment and remain steady throughout the study.
Key exclusion criteria (16 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.
- History of presence of condition (s) that meet the criteria for major depressive disorder (MDD), bipolar disorder, or any other personality disorders, at the discretion of the investigator.
- Presence of cancer pain, acute pain following injury or other severe pain not primarily associated with fibromyalgia, at discretion of the investigator.
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 DeviceAudio Visual Stimulation patterns intended to produce a therapeutic benefit. | Device | Active Treatment |
| Sana Device (Control)A control device that mimics the physcial appearance of the Sana device. | Drug | Sham Arm |
Primary outcome
Change in Fibromyalgia Symptoms
Time frame: 6 weeks
To confirm the superiority of the active arm over sham on changes in quality of life as measured by the Fibromyalgia Impact Questionnaire Revised (FIQR)
5 secondary outcomes
Changes in Generalized Anxiety Symptoms
Time frame: 6 weeks
Changes in Depression Symptoms
Time frame: 6 weeks
Changes in Sleep Quality
Time frame: 6 weeks
Changes in Pain
Time frame: 6 weeks
Perceived Change in Quality of Life
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- 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.
Martin Cheatle, PhD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Sana Device in people with Fibromyalgia and Pain, Chronic, run by Sana Health.
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 10 inclusion and 16 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: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Fibromyalgia Symptoms (time frame: 6 weeks). 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 24 Apr 2026.