Apollo Device for Scleroderma
(ASScERT-QoL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a wearable device called the Apollo Neuro to determine its effectiveness in helping people with systemic sclerosis (SSc) manage symptoms like fatigue and Raynaud phenomenon, which causes cold and numb fingers. Participants will receive either the real device or a sham (inactive) device to compare results. The study aims to improve symptom management and quality of life for those with SSc. Suitable candidates have been diagnosed with SSc, experience fatigue and Raynaud phenomenon, and regularly use a smartphone. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance symptom management for SSc.
Will I have to stop taking my current medications?
You can continue taking your current medications if they are immunosuppressive drugs, vasodilators, or medications for pulmonary hypertension, antidepressants, and anxiolytics, as long as you've been on a steady dose for 4 weeks before starting the trial. However, you cannot be on beta-blockers, sedatives, hypnotics, opioids, benzodiazepines, or anti-psychotic medications.
What prior data suggests that the Apollo Neuro device is safe for Scleroderma patients?
Research has shown that the Apollo Neuro device is generally safe and easy to use. In earlier studies, participants who used the Apollo wearable for four weeks reported feeling less tired and experiencing fewer Raynaud's attacks, common issues for those with systemic sclerosis. Importantly, these studies did not find any major side effects, indicating the device's safety. Current evidence suggests that the Apollo device is a promising way to manage symptoms without causing harm.12345
Why are researchers excited about this trial?
Most treatments for scleroderma, like immunosuppressants and anti-fibrotic drugs, work by slowing down the immune system or reducing tissue thickening. However, the Apollo Neuro Device is different because it uses gentle vibrations to help regulate the nervous system, aiming to reduce stress and improve overall well-being. This is a non-invasive method that doesn't involve drugs, which could mean fewer side effects compared to traditional medications. Researchers are excited because it offers a novel way to potentially manage symptoms by focusing on the body's stress response, which is often overactive in scleroderma patients.
What evidence suggests that the Apollo Neuro Device is effective for managing symptoms of scleroderma?
Research has shown that the Apollo Neuro device, which participants in this trial may receive, might help alleviate anxiety and stress through gentle vibrations that calm the nervous system. These vibrations can enhance the body's ability to manage stress, potentially reducing fatigue and improving overall well-being. Although specific data on systemic sclerosis (SSc) is limited, the device's capacity to promote relaxation and reduce stress might aid in alleviating SSc symptoms such as fatigue and Raynaud phenomenon, where fingers and toes feel numb and cold. Early users have reported feeling calmer and more focused, suggesting the device could enhance quality of life.
Who Is on the Research Team?
Robyn T Domsic, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for individuals with Systemic Sclerosis, a condition that causes hardening and tightening of the skin. Participants should experience fatigue and Raynaud's phenomenon, which involves poor blood flow to certain parts of the body like fingers and toes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either the Apollo Neuro device or a sham device, which they will wear daily for 6 weeks
Follow-up
Participants are monitored for changes in fatigue, Raynaud attacks, and quality of life after the treatment phase
What Are the Treatments Tested in This Trial?
Interventions
- Apollo Neuro Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Robyn T. Domsic, MD, MPH
Lead Sponsor
United States Department of Defense
Collaborator