Digital Speech Markers for Monitoring ALS in Spanish Speakers

The goal of this observational study is to learn how speech and breathing change over time in Spanish-speaking individuals with amyotrophic lateral sclerosis (ALS) compared to age- and gender-matched individuals without ALS. The main questions it aims to answer are: Can speech and breathing measures collected through a smartphone application serve as reliable digital biomarkers to track bulbar disease decline in Spanish-speaking people with ALS? How do these measures differ between individuals with ALS and those without ALS? Researchers will compare Spanish-speaking participants with ALS to age- and gender-matched healthy controls to see if specific speech and breathing features can identify or predict bulbar decline. Participants will: Use a Spanish-language smartphone application to record speech and breathing tasks over time. Complete assessments of speech, breathing, and functional abilities (e.g., ALS Functional Rating Scale). Provide data that will be compared to caregiver reports and clinical outcomes to validate new digital biomarkers.

NCT Number	NCT07341334
Lead Sponsor	Nova Southeastern University Collaborators: Peter Cohen Foundation (PCF)
Conditions	Amyotrophic Lateral Sclerosis, Lou Gehrig's Disease, ALS
Enrollment	35 participants
Start Date	2026-08
Primary Completion	2029-12 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-03