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

Korábbi kezelés

• Major surgery within 8 weeks
• Medication exclusions:
  • actively prescribed standing doses of beta-blockers,
  • actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.

Más betegség

• History of sympathectomy or stellate ganglion block
• History of Botox injections to the digits within the last 3 months
• Diabetes mellitus
• Active malignancy
• End-stage renal disease (estimated glomerular filtration rate < 15 mL/min/1.73m2) or on dialysis,
• Hepatic insufficiency as defined by function worse than Child-Pugh Class B

Egyéb

• Hospitalization for any reason within four weeks of the study baseline visit
• Pregnant or breastfeeding women,

• 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.