MSPEECH (multiple sclerosis monitoring through speech interaction in clinic and at home): a Living Lab study protocol for co-created, speech-based digital biomarkers in multiple sclerosis.

Multiple sclerosis (MS) has heterogeneous trajectories and fluctuating symptoms that are often not captured by intermittent clinic assessments. Digital health tools can provide frequent, low-burden measurements, but clinical translation requires sustained engagement, interpretability, robust governance, and workflow integration. MSPEECH is a single-center, prospective, non-interventional Living Lab study at the MS Center Dresden conducted with ki:elements GmbH to co-create and iteratively refine the Mili smartphone/tablet speech assessment app. The protocol comprises three demonstrator cycles with structured co-design (people with MS and clinicians), implementation within predefined boundaries while keeping core tasks/schedules/security stable, and a 12-week home-based evaluation per version. The battery includes multiple speech tasks (e.g., fluency, reading, "Pa-Ta-Ka," sustained phonation) and a dual-task module combining touchscreen fine-motor tracking with concurrent speech. A dedicated Ethical, Legal and Social Issues (ELSI) board provides continuous oversight. Primary outcomes are usability and acceptability (MAUQ plus qualitative feedback); secondary outcomes include feasibility/engagement, privacy perceptions, report interpretability, clinician workflow fit, and exploratory associations with clinical reference indicators.