Apollo DeviceThe Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life

Inclusion Criteria:

1. Age ≥ 18 years
2. Ability to provide written informed consent,
3. Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
4. Baseline score ≥55 on the FACIT-Fatigue scale,
5. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
6. 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
7. Currently owns and operates an iOS or Android smart phone regularly
8. Ability to comply with the clinical visits schedule and the study-related procedures.

Exclusion Criteria:

1. History of sympathectomy or stellate ganglion block
2. History of Botox injections to the digits within the last 3 months
3. Diabetes mellitus
4. Major surgery within 8 weeks
5. Hospitalization for any reason within four weeks of the study baseline visit
6. Active malignancy
7. Pregnant or breastfeeding women,
8. End-stage renal disease (estimated glomerular filtration rate < 15 mL/min/1.73m2) or on dialysis,
9. Hepatic insufficiency as defined by function worse than Child-Pugh Class B
10. Medication exclusions:

1. actively prescribed standing doses of beta-blockers,
2. actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.