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

Launched by ROBYN T. DOMSIC, MD, MPH · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the Apollo Neuro device, a wearable gadget designed to help manage symptoms and improve the quality of life for people with systemic sclerosis (SSc). The main focus is on two common issues that many patients face: fatigue and Raynaud phenomenon, which causes fingers and toes to feel cold and numb. By participating in this study, you could help researchers understand if this device can effectively make a difference in how patients feel day-to-day.

To be eligible for the trial, you need to be at least 18 years old and diagnosed with systemic sclerosis. You should also experience significant fatigue and have Raynaud phenomenon. It’s important that you have been stable on your medications for at least four weeks and regularly use a smartphone. Participants can expect to attend scheduled visits for assessments, and they will receive guidance on using the device throughout the study. If you have certain medical conditions or have recently undergone specific treatments, you may not be eligible, but the research team will provide detailed information during the screening process.

Gender

ALL

Eligibility criteria

• 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.