AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - anyAllRobyn T. Domsic, MD, MPH
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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 โ‰ฅ55 on the FACIT-Fatigue scale, 5. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score โ‰ฅ40, 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.
๐Ÿ’Š

What it tests

  • Apollo Neuro Device
  • Sham device
๐Ÿ“

Where

4 sites
DelRicht Research Center
New Orleans, United States
University of Michigan
Ann Arbor, United States
University of Pittsburgh and UPMC Scleroderma Center
Pittsburgh, United States
Vanderbilt University Medical Center
Nashville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy