Testing a wearable device for fatigue and Raynaud symptoms in systemic sclerosis
Tests a wearable Apollo device against a sham device in adults with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
Key facts
- Where
- Ann Arbor, Nashville, New Orleans, and Pittsburgh, United StatesSee the 4 sites
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- DelRicht Research CenterNew Orleans, United StatesTaking people
- University of Pittsburgh and UPMC Scleroderma CenterPittsburgh, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Robyn T. Domsic, MD, MPH
- Trial code
- NCT06675344
- Record updated
- 8 January 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Double-blind, Clinical Trial of the Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life (ASScERT-QoL)
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.
Inclusion: 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.
Exclusion: 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; 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; Hospitalization for any reason within four weeks of the study baseline visit; Pregnant or breastfeeding women,.