Wearable in Systemic Sclerosis: A Pilot Study of the Apollo Wearable Demonstrates Improvement in Fatigue, Raynaud Phenomenon and Quality-of-Life in Patients with Systemic Sclerosis.

Abstract

Objective: In systemic sclerosis (SSc) patients, fatigue is the highest ranked symptom affecting quality of life (QoL), followed by Raynaud phenomenon (RP). We report results from a pilot study (NCT04854850) of the Apollo wearable device in SSc patients.

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 PROMIS-Fatigue 13a (PROMIS-Fatigue) scale at 4 weeks. (ClinicalTrials.gov Identifier: NCT04854850) 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 < 0.01), as did the Raynaud condition score (p<0.001) after 4 weeks of use. Average device usage (2.87 hours per day) far exceeded the requested time, and no adverse events occurred. The PROMIS-29 sub scores assessment demonstrated quality of life (QoL) improvement in physical function (p <0.01), sleep disturbance (p = 0.001), and ability to participate in social roles and activities (p < 0.001). Significant improvements were also noted for depression (p < 0.01) and disability (p < 0.05) measures.

Conclusion: Use of the Apollo wearable for four weeks was associated with improvement in fatigue and RP symptom in SSc patients, with improved QoL measures and lower depression scores. Future studies should further test the efficacy of the Apollo wearable in these domains and SSc patient QoL.