Apollo Device for Scleroderma
(ASScERT-QoL Trial)
Trial Summary
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 is the purpose of this trial?
The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.
Research Team
Robyn T Domsic, MD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
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
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
Treatment Details
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