Apollo Device for Fatigue in Systemic Sclerosis (NCT04854850) | Clinical Trial Compass
CompletedNot Applicable
Apollo Device for Fatigue in Systemic Sclerosis
United States25 participantsStarted 2020-07-07
Plain-language summary
The purpose of this study is to learn about the effect of Apollo (a vibrating wearable about the side of an Apple Watch) on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic sclerosis.
SSc patients frequently have fatigue as a characteristic feature of their disease and fatigue negatively impacts quality of life (Haythornthwaite 2003, Richards 2003, Suarez-Almazor 2007, Basta 2017). The prevalence of fatigue among SSc patients is 75%, with 61% ranking fatigue among their top three most distressing complaints. Fatigue is also associated with poor sleep quality, greater pain and depressive symptoms (Sandusky 2009). We hypothesize that treatment with Apollo over 1 month will improve fatigue. If successful, the Apollo technology will be the first treatment option for fatigue and Raynaud's in this population.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent
✓. Men or women aged 18 years and older
✓. Diagnosis of Systemic sclerosis, as defined by 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
✓. Baseline T score of 45 on the PROMIS-Fatigue scale.
✓. Steady daily doses and any immunosuppressive medication, vasodilators, 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.
✓. Subjects who have struggled with symptoms of SSc (specifically fatigue and Raynauds) who have not received adequate symptom relief from prior treatment attempts (treatment-resistant) will be prioritized.
Exclusion criteria
✕. Medical and surgical history
What they're measuring
1
Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline
Timeframe: Change in FACIT-Fatigue from baseline to 4 weeks
✕. Other • Any other condition or therapy that would make the participant unsuitable for this study and will not allow participation for the full planned study period