Digital Speech Markers for Monitoring ALS in Spanish Speakers

NCT07341334 | Not Yet Recruiting DMC

• 1 other identifier: 2025-224-NSU
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease; ALS

Keywords

speech biomarkers; amyotrophic lateral sclerosis; Lou Gehrig's disease; ALS

Outcome Measures

Primary Outcomes (1)

• Oral Speaking Rate

  Speaking rate (words per minute): a measure of the rate of speech during oral reading.

  From enrollment to 2-4 years

Secondary Outcomes (2)

• Maximum Phonation Time (Seconds)

  Enrollment to 2-4 years of observations

• Listener Effort

  Enrollment 2-4 years

Other Outcomes (2)

• Peak Expiratory Cough Flow

  Enrollment to 2-4 years of observations

• Forced Vital Capacity

  2-4 years

Study Arms (2)

People diagnosed with ALS

This group will be the group of 30 (anticipated) participants diagnosed with ALS.

Age and Gender matched control group

This group is the group of 5 (anticipated) control adults not diagnoses with ALS.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is monolingual Spanish speakers or bilingual English-Spanish speakers diagnosed with amyotrophic lateral sclerosis.

You may qualify if:

• diagnosis of definite ALS
• monolingual or first language Spanish speaker
• literate in Spanish
• ALS Functional Rating Scale speech score of ≧2

You may not qualify if:

• no diagnosis of concomitant respiratory disease such as COPD, emphysema, or current TOB use.

Sponsors & Collaborators

• Nova Southeastern University: lead
• Peter Cohen Foundation (PCF): collaborator

Study Sites (1)

Cathy J Husman ALS Center at Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lauren Tabor Gray, Ph.D CCC-SLP

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Navarrete, B.S

CONTACT

(954)857-5346; vnavarre@nova.edu

Eden Pressley, B.S

CONTACT

ep1200@nova.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)