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.
Age ≥ 18 years
Ability to provide written informed consent,
Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
Baseline score ≥55 on the FACIT-Fatigue scale,
History of sympathectomy or stellate ganglion block
History of Botox injections to the digits within the last 3 months
Diabetes mellitus
Major surgery within 8 weeks
Robyn T. Domsic, MD, MPH
Lead sponsor
University of Pittsburgh
Sponsor institution
United States Department of Defense
Collaborator