N/A
N=34
DESIPHER_Speech Degradation as an Indicator of Physiological Degeneration in ALS
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02675075 ↗Enrolled (actual)
34
Serious AEs
11.8%
Results posted
Aug 2020
Primary outcome: Primary: Change in Percent of Expected Lung Force Vital Capacity — -1.25 % Expected Forced Vital Capacity
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent of Expected Lung Force Vital Capacity |
-1.25 | — |
| SECONDARY Change in Tongue Strength |
-.625 | — |
| SECONDARY Change in Speech - as Measured by Speech Divergence |
1.88 | — |
Summary
A disease called Amyotrophic lateral sclerosis (or ALS), which leads to difficulty swallowing, breathing, and movement, has been found to be higher for those serving in the military than in the general population. There are approximately 4,200 Veterans with ALS and roughly 1,000 new cases each year. When doctors attempt to determine the degree to which an ALS patient is suffering from the disease, they apply tests that are "graded" by experts. However, this approach to testing patients may not be very accurate. Researchers aim to use a system called DESIPHER to "listen" to ALS patients and find speech mistakes related to their condition. Researchers believe that, by detecting different types of errors, DESIPHER serves as a new kind of indicator of medical problems such as difficulty breathing or swallowing, without human "grading". This may also lead to a better system for automatically understanding ALS patients' speech.
Eligibility Criteria
Inclusion Criteria
- Veterans will be diagnosed with ALS
- Native speakers of U.S. English
- Will have bulbar involvement identified during initial ALS inpatient evaluation
- Forced vital capacity (FVC) of greater than 50% of the expected value for age
- An Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) Score of 40 or greater
Exclusion Criteria
- A diagnosis of dementia
- FVC less than 50%
- Inability to speak
- Or inability to follow directions
Data sourced from ClinicalTrials.gov (NCT02675075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.