Actively Recruiting
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
Led by Robyn T. Domsic, MD, MPH · Updated on 2026-01-08
160
Participants Needed
4
Research Sites
190 weeks
Total Duration
On this page
Sponsors
R
Robyn T. Domsic, MD, MPH
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to provide written informed consent
- Diagnosed with systemic sclerosis according to 2013 ACR/EULAR classification with positive ANA
- Baseline FACIT-Fatigue scale score of 55 or higher
- Presence of Raynaud phenomenon with ASRAP-SF severity T-score of 40 or higher
- Stable daily doses of immunosuppressive medications, vasodilators, pulmonary hypertension treatments, antidepressants, or anxiolytics for at least 4 weeks before baseline
- Regular use of an iOS or Android smartphone
- Able to comply with study visits and procedures
You will not qualify if you...
- History of sympathectomy or stellate ganglion block
- Botox injections to fingers within last 3 months
- Diagnosis of diabetes mellitus
- Major surgery within 8 weeks before study
- Hospitalization within 4 weeks before baseline visit
- Active cancer
- Pregnant or breastfeeding women
- End-stage kidney disease (eGFR < 15 mL/min/1.73m2) or on dialysis
- Liver failure worse than Child-Pugh Class B
- Current use of beta-blockers
- Current use of sedatives, hypnotics, opioids, benzodiazepines, or antipsychotic medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
DelRicht Research Center
New Orleans, Louisiana, United States, 70115
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
University of Pittsburgh and UPMC Scleroderma Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
M
Maureen M Laffoon, BS
CONTACT
R
Robyn T Domsic, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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