Digital Speech Markers for Monitoring ALS in Spanish Speakers
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorNova Southeastern University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
diagnosis of definite ALS
monolingual or first language Spanish speaker
literate in Spanish
ALS Functional Rating Scale speech score of ≧2
Disqualifiers
no diagnosis of concomitant respiratory disease such as COPD, emphysema, or current TOB use.
Trial population
The study population is monolingual Spanish speakers or bilingual English-Spanish speakers diagnosed with amyotrophic lateral sclerosis.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
35 Participants
are grouped into 2 trial groupsGroup A: People diagnosed with ALS
Group B: Age and Gender matched control group
Trial outcomes
Primary outcomes
1
Oral Speaking Rate
Speaking rate (words per minute): a measure of the rate of speech during oral reading.
Time frame
From enrollment to 2-4 yearsSecondary outcomes
1
Maximum Phonation Time (Seconds)
The duration of maximum sustained phonation during the production of "ah" as in "father". Participants will take a deep breath and make the sound for as long as possible. Two trials will be recorded each time.
Time frame
Enrollment to 2-4 years of observations2
Listener Effort
A perceptual rating of the amount of work necessary for a listener to understand speech, rated by an expert speech-language pathologist on a visual analog scale from 0 (easily understood)- 100 (unintelligible even with full effort)
Time frame
Enrollment 2-4 yearsOther outcomes
1
Peak Expiratory Cough Flow
The maximum expiratory airflow velocity achieved during voluntary cough following maximum inspiration (L/min).
Time frame
Enrollment to 2-4 years of observations2
Forced Vital Capacity
The maximum lung volume that a participant can generate. (raw mL)
Time frame
2-4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nova Southeastern University
Lead sponsor
Peter Cohen Foundation (PCF)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: