Digital Phenotyping and Lifestyle Intervention in Patients With Myasthenia Gravis (DIG-MG): A Randomized Controlled...

Physical activity and sleep influence fatigue in myasthenia gravis (MG), and digital health technologies (DHT) enable objective monitoring of these behaviors in daily life. Using this approach, we evaluated whether a lifestyle intervention targeting physical activity or sleep hygiene could reduce fatigue in MG.

In this three-arm, randomized controlled trial (DIG-MG; NCT05992025), 72 MG patients completed 6 weeks of baseline monitoring with a DHT ring (OURA), followed by 12 weeks of (i) physical activity guidance, (ii) sleep hygiene education, or (iii) observation, and a 6-week follow-up. The primary outcome was the MG Activities of Daily Living (MG-ADL) score 1 week postintervention. Secondary outcomes included Fatigue Severity Scale (FSS) scores; exploratory outcomes were DHT-derived physical activity and sleep parameters.

Baseline MG-ADL scores were similar (median: 5.0). Postintervention medians were 4.0 (physical activity), 3.5 (sleep hygiene), and 3.0 (control), with no significant differences (p = 0.073). Clinically meaningful MG-ADL improvement occurred in six, seven, and six participants, respectively. FSS scores showed no group differences (p = 0.992), with clinically relevant improvement in eight participants in each intervention group and five controls. Participants were more physically active than expected: 64.7% exceeded 600 MET-min/week at baseline. DHT adherence was excellent. REM sleep was lower than expected, while deep sleep was preserved. Self-reported data aligned with DHT measurements.

Digital lifestyle interventions were feasible and well-accepted but did not improve MG-ADL or FSS in this unusually active population. However, DHT-based monitoring may support individualized follow-up, and reduced REM sleep warrants further investigation as a fatigue-related factor.