Apollo Neuroscience is collaborating with the University of Pittsburgh in an effort to access if the company’s wearable, Apollo, can help with combating fatigue in patients with systemic sclerosis.
Systemic sclerosis is a rare chronic disease where the immune system attacks the body. Apart from shortness of breath, dry cough and joint pain, many patients of this rare autoimmune disease suffer from chronic fatigue-like symptoms.
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Fatigue is a common issue for people living with chronic conditions. A study supported by the Scleroderma Research Foundation found that over 75% of people with scleroderma experienced fatigue, and for 61% of these, it was reported to be one of the most distressing symptoms of the condition.
Apollo Neuroscience’s wearable is a wrist-worn device that is similar in size to an Apple Watch and is known to help fight stress in users. The wearable delivers vibrations that help stimulate the body’s rest and digest parasympathetic nervous responses. Using the companion app, users are able to choose from seven distinct modes that have different goals such as ‘Rebuild & Recover’, ‘Meditation and Mindfulness’, and more.
The purpose of this new study is to learn about the effect of Apollo on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic sclerosis.
The study designers believe 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.
The study will recruit 30-40 patients 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. Furthermore, 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 effectiveness.
The Apollo neuro device is currently not a medical device and we believe the company aims to use this study and other studies to help build its case for future FDA approval.