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Digital Speech Markers for Monitoring ALS in Spanish Speakers

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Notable Start date: Apr 2026 to Aug 2026v3
  2. Notable Start date: Jan 2026 to Apr 2026
    • Collaborator revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07341334
Lead Sponsor Nova Southeastern University
Collaborators: Peter Cohen Foundation (PCF)
Conditions
(from sponsor)
Amyotrophic Lateral Sclerosis, Lou Gehrig's Disease, ALS
Related terms Amyotrophic Lateral Sclerosis
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov