The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qua… (NCT06675344) | Clinical Trial Compass
RecruitingNot Applicable
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
United States160 participantsStarted 2025-01-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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,
✓. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
✓. Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, 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.
Exclusion criteria
✕. 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
✕. Hospitalization for any reason within four weeks of the study baseline visit