Association of the Apollo Wearable With Fatigue, Raynaud Phenomenon, and Quality of Life in Patients With Systemic Sclerosis: A Pilot Study.

Objective: In patients with systemic sclerosis (SSc), fatigue is the highest-ranked symptom affecting quality of life (QOL), followed by Raynaud phenomenon (RP). We report results from a pilot study of the Apollo wearable device in patients with SSc.

Methods: Twenty-five adult participants with SSc, moderate fatigue, and RP were enrolled. Participants completed a 4-week intervention, during which they wore the Apollo device daily for a minimum of 15 minutes. The primary outcome was change on the Patient Reported Outcomes Measurement Information System Fatigue 13a (PROMIS Fatigue) at 4 weeks.

Results: After 4 weeks of using the Apollo wearable, participants reported less fatigue on the PROMIS Fatigue (P < 0.001) scale. The average daily number of RP attacks declined (P = 0.007), as did the Raynaud Condition Score (P = 0.007) after 4 weeks of use. Average device usage (2.87 hours/day) far exceeded the requested time, and no adverse events occurred. The PROMIS-29 subscores assessment demonstrated QOL improvement in physical function (P = 0.01), depression (P = 0.03), fatigue (P = 0.01), sleep disturbance (P = 0.002), and ability to participate in social roles and activities (P < 0.001). Significant improvements were also noted for depression (P = 0.004) and disability (P < 0.05) measures.

Conclusion: Use of the Apollo wearable for 4 weeks was associated with improvement in fatigue and RP symptoms in patients with SSc, with improved QOL measures, lower depression scores, and improved disability measures. Future studies should further test the efficacy of the Apollo wearable in these domains and QOL of patients with SSc. (ClinicalTrials.gov: NCT04854850).