The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Systemic Sclerosis (SSc)
In brief
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.
Key facts
- Study ID
- NCT06675344
- Run by
- Robyn T. Domsic, MD, MPH
- People needed
- 160
- Starts
- 2025-01-06
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- History of sympathectomy or stellate ganglion block
- History of Botox injections to the digits within the last 3 months
- Diabetes mellitus
- Major surgery within 8 weeks
- Hospitalization for any reason within four weeks of the study baseline visit
- Active malignancy
- Pregnant or breastfeeding women,
- 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
- Medication exclusions:
- actively prescribed standing doses of beta-blockers,
- actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.
Where it is running
- DelRicht Research Center — New Orleans, Louisiana, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- University of Pittsburgh and UPMC Scleroderma Center — Pittsburgh, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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