Developing Digital Speech Biomarkers of Bulbar Disease Decline in Spanish-Speaking Persons With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Oral Speaking Rate
研究概览
简要总结
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.
详细描述
BACKGROUND AND RATIONALE Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder characterized by the loss of upper and lower motor neurons, leading to paralysis, speech and swallowing decline, and respiratory failure. Approximately 90% of people living with ALS (pALS) experience bulbar symptoms, which severely affect communication, nutrition, and overall quality of life. Despite their clinical significance, bulbar symptoms remain poorly characterized, particularly in non-English-speaking populations. The absence of validated Spanish-language digital biomarkers represents a significant gap in the ability to monitor disease progression, design inclusive clinical trials, and improve access to care.
This observational study aims to address that gap by developing and validating speech- and respiratory-based digital biomarkers for monitoring bulbar disease decline in Spanish-speaking individuals with ALS, using a smartphone application designed for remote data collection.
STUDY DESIGN AND OBJECTIVES This is a prospective, longitudinal observational study involving approximately 30 Spanish-speaking individuals with ALS (pALS) and 5 age- and gender-matched healthy controls. The study leverages a Spanish-language Everything ALS smartphone application for data collection.
Primary Objectives:
Develop and validate speech and respiration-based digital biomarkers for tracking bulbar disease decline in Spanish-speaking pALS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of definite ALS
- •monolingual or first language Spanish speaker
- •literate in Spanish
- •ALS Functional Rating Scale speech score of ≧2
排除标准
- •no diagnosis of concomitant respiratory disease such as COPD, emphysema, or current TOB use.
研究组 & 干预措施
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.
结局指标
主要结局
Oral Speaking Rate
时间窗: From enrollment to 2-4 years
Speaking rate (words per minute): a measure of the rate of speech during oral reading.
次要结局
- Maximum Phonation Time (Seconds)(Enrollment to 2-4 years of observations)
- Listener Effort(Enrollment 2-4 years)