Apollo Device for Fatigue in Systemic Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to learn about the effect of Apollo (a vibrating wearable about the side of an Apple Watch) on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic sclerosis. SSc patients frequently have fatigue as a characteristic feature of their disease and fatigue negatively impacts quality of life (Haythornthwaite 2003, Richards 2003, Suarez-Almazor 2007, Basta 2017). The prevalence of fatigue among SSc patients is 75%, with 61% ranking fatigue among their top three most distressing complaints. Fatigue is also associated with poor sleep quality, greater pain and depressive symptoms (Sandusky 2009). We hypothesize that treatment with Apollo over 1 month will improve fatigue. If successful, the Apollo technology will be the first treatment option for fatigue and Raynaud's in this population.

Detailed Description
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This is a study of the commercially available Apollo Neuro Wellness Device, which is not currently a medical device. The device offers a convenient novel non-invasive, non-habit-forming solution to improve performance and recovery under stress in children and adults by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time (Siegle & Rabin et al., under review). Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy. A total of 30-40 patients will be enrolled and followed for 1 month, with baseline data collected before using Apollo and follow-up data collected after using the device. This clinical trial is open-label, meaning that all participants will receive Apollos and no placebos will be used. All participants will be allowed to continue underlying immunosuppressive and Raynaud therapy at stable doses during the trial. Since this is a pilot study, future larger controlled trials will be necessary to clearly demonstrate drug effectiveness.

Official Title
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An Open-Label Study of the Apollo Device for Fatigue in Systemic Sclerosis

Conditions
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Systemic Sclerosis, Fatigue, Raynaud Phenomenon

Intervention / Treatment
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* Device: Apollo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent Men or women aged 18 years and older Diagnosis of Systemic sclerosis, as defined by 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc. Baseline T score of 45 on the PROMIS-Fatigue scale. Steady daily doses and any immunosuppressive medication, vasodilators, antidepressants and anxiolytic use for 4 weeks prior to baseline. Currently owns and operates an iOS or Android smart phone regularly Ability to comply with the clinical visits schedule and the study-related procedures. Subjects who have struggled with symptoms of SSc (specifically fatigue and Raynauds) who have not received adequate symptom relief from prior treatment attempts (treatment-resistant) will be prioritized. Exclusion Criteria: Medical and surgical history Major surgery within 8 weeks prior to screening Participants with an active malignancy. End-stage renal disease with an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m2 (MDRD formula) or on dialysis at the screening visit Hepatic insufficiency as defined by the Child-Pugh criteria Hospitalization for any reason within four weeks of the study baseline visit. History of sympathectomy or stellate ganglion block Significant interstitial lung disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted Pulmonary hypertension with change in medications in the preceding four weeks Actively prescribed standing doses of beta-blockers. Actively prescribed standing doses of sedatives, hypnotics, opioids, or benzodiazepines. Active or unstable psychotic disorder requiring current prescriptions of standing doses of antipsychotic medications Active suicidal/homicidal ideation or a suicide or homicide attempt in the past year. Pregnant or breastfeeding women Other • Any other condition or therapy that would make the participant unsuitable for this study and will not allow participation for the full planned study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apollo<br>Participants will all receive Apollo devices. | Device: Apollo<br>* The Apollo System offers a convenient novel non-invasive, non-habit-forming solution to improve performance and recovery under stress in children and adults by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time (Siegle & Rabin et al., under review). The gentle vibrations delivered by the Apollo System are extremely low intensity in that they are typically just barely noticeable or perceptible by the user. Additionally, the range of frequencies and intensities of the Apollo System have been safely used in numerous commercial products without adverse events reported, including sexual vibrators and massagers. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy.<br>* Other names: Tuned Vibrartory Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline | The FACIT-Fatigue is a patient reported outcome of fatigue symptoms, with a score range of 13-65. Low scores indicate low levels of fatigue and high scores indicate high levels of fatigue. | Change in FACIT-Fatigue from baseline to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline | The HAQ-D1/SHAQ is a patient-reported outcome of functional ability. It is a continuous scale with a results range of 0-3, with 0 meaning no disability and 3 meaning very severe disability. | Change in HAQ-D1/SHAQ from baseline to 4 weeks | 
| The Median Change in the Raynaud Phenomenon Visual Analog Scale (RP-VAS) Score at 4 Weeks (End-of-study) Compared to Baseline | The RP-VAS scale measure ranges from 0-100, with 0 being no symptoms and 100 severe symptoms. Reported is the median and interquartile range of change between baseline and week 4 (end-of-study). | Change in RP-VAS from baseline to 4 weeks | 
| Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline | The Raynaud Consition Score is a patient-reported outcome of a single question regarding Raynaud severity. It is a visual analog scale with a results range of 0-100. A score of 0 is no symptoms, and 100 is severe symptoms. It is recommended by OMERACT for assessment of Raynaud phenomenon. | From baseline to 4-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Sclerosis, Fatigue, Raynaud, Pain