Digital Speech Markers for Monitoring ALS in Spanish Speakers

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Nova Southeastern University
Study ID
NCT07341334
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
35 participants (estimated)

Arms

  • Arm: People diagnosed with ALS
    This group will be the group of 30 (anticipated) participants diagnosed with ALS.
  • Arm: Age and Gender matched control group
    This group is the group of 5 (anticipated) control adults not diagnoses with ALS.

Primary Outcome Measure

Oral Speaking Rate [ Time Frame: From enrollment to 2-4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cathy J Husman ALS Center at Nova Southeastern UniversityFort LauderdaleFlorida33314-

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