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DESIPHER_Speech Degradation as an Indicator of Physiological Degeneration in ALS

DESIPHER Speech Degradation as an Indicator of Physiological Degeneration in ALS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02675075
Enrollment
34
Registered
2016-02-05
Start date
2016-01-01
Completion date
2017-12-31
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis, Voice, Voice Quality, Total Lung Capacity

Brief 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.

Detailed description

In 2008, Amyotrophic lateral sclerosis (ALS) or Lou Gehrig's Disease became a presumptively compensable (service connected) disease as the Institute of Medicine (IOM) Committee stated an association between the development of ALS and military service. According to the IOM report, military service increases life risk of ALS by 1.5 fold. There are approximately 4,200 Veterans with ALS and roughly 1,000 new cases each year. At the Tampa VA, since 2007, there has been a consistent rise in the number of Veterans diagnosed and treated with ALS. Most physiological assessments that are commonly used to determine the functional status of patients with ALS require trained clinical personnel to administer and interpret the results. The investigators propose to use automatic speech understanding and machine learning software (DESIPHER) to: identify speech pathologies and use them to predict other aspects of physiological degeneration associated with ALS (e.g., respiratory difficulty or inability to swallow), and ultimately improve speech recognition for those with speech impairments. The investigators expect this to improve the ability to appropriately identify and intervene when Veterans with ALS are at risk of serious adverse medical issues such as respiratory failure and aspiration. The investigators postulate that analyzing the overall divergence of (impaired) speech, from a normal baseline, will prove to be more robust and a better marker for involvement than others that have been proposed. Specific research questions to be addressed by this study are: (1) Is it possible to train a speech recognition system to adapt to increasingly more frequent language/speech errors of particular types, to produce an accurate textual transcript that would be readable by an ALS patient's caregiver or physician? (2) Are specific changes in physiological functioning: Forced Vital Capacity, tongue strength, speech velocity, weight (loss), aspiration risk, or psychological distress, reflected in different types of language/speech errors associated with ALS? By understanding how speech functioning correlates with the degree to which other biophysical functioning has degraded, it is possible to apply a new, non-invasive measure for assessing the functionality of an ALS patient. In addition, the features associated with speech degradation it is possible to adapt existing speech recognition software to a patient's speech as it evolves over time, so that the quality of life for patients may be improved through conversation with a computer. Respiratory failure is the main cause of morbidity and mortality in ALS patients. The investigators expect that the method of analyzing speech will present an excellent biomarker for respiratory function, as there is an expected increase in pauses during speech due to the necessity of increased frequency of respirations, a decrease in loudness, and decreased overall velocity of speech. A second major cause of death is aspiration. As the articular muscles decline, the investigators expect to note a decrease in the clarity of speech. Speech involvement often precedes swallowing involvement in ALS; thus, the investigators expect that increasing speech divergence will indicate potential aspiration risk.

Interventions

None listed

Sponsors

Florida Institute for Human and Machine Cognition
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Percent of Expected Lung Force Vital CapacityBaseline, and every 3 months up to 24 monthsForced Vital Capacity (FVC) measures the ability of the lung to move air. The change in FVC was calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup.

Secondary

MeasureTime frameDescription
Change in Tongue StrengthBaseline, 3 Month intervals up to 24 months, calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followupA physiological measurement of tongue muscle strength, in multiple directions. A force measured with Iowa Oral Performance Instrument (IOPI)
Change in Speech - as Measured by Speech DivergenceBaseline, 3 Month intervals up to 24 months, calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followupA measure looking at changes in vocal characteristics away from standard language. Speech Divergence is a novel calculated measure based on identifying changes to 13 characteristics of speech. The score can range from 0-13. Zero would represent normal speech, while 13 would be distorted speech along all parameters.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from the amyotrophic lateral sclerosis (ALS) Clinic at the James A. Haley Hospital from January 2016 to November 2017

Participants by arm

ArmCount
Veterans With ALS
This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria. Veterans were at least 18 years old, and were diagnosed with ALS, and followed at the James A Haley VA Hospital
15
Healthy Controls
Healthy Controls were recruited to complete a one time vocal recording of the TIMIT and Ba repetition voice recordings.
19
Total34

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up30

Baseline characteristics

CharacteristicVeterans With ALSHealthy ControlsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants5 Participants12 Participants
Age, Categorical
Between 18 and 65 years
8 Participants14 Participants22 Participants
Age, Continuous63.4 years
STANDARD_DEVIATION 10.8
53.3 years
STANDARD_DEVIATION 11.2
57.8 years
STANDARD_DEVIATION 11.6
ALS Functional Ratings Scale-Revised32.5 units Standardized Outcome Measu
STANDARD_DEVIATION 7.4
32.5 units Standardized Outcome Measu
STANDARD_DEVIATION 7.4
Lip Strength15.5 kPa
STANDARD_DEVIATION 9
15.5 kPa
STANDARD_DEVIATION 9
Percent of Predicted Forced Vital Capacity (FVC)69.1 Expected % Max FVC
STANDARD_DEVIATION 21.9
69.1 Expected % Max FVC
STANDARD_DEVIATION 21.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
13 Participants16 Participants29 Participants
Sex: Female, Male
Female
1 Participants12 Participants13 Participants
Sex: Female, Male
Male
14 Participants7 Participants21 Participants
Speech Intelligence Test98.6 Percent words Intellegible
STANDARD_DEVIATION 4.5
98.6 Percent words Intellegible
STANDARD_DEVIATION 4.5
Tongue Strength31.6 KPa
STANDARD_DEVIATION 17.2
31.6 KPa
STANDARD_DEVIATION 17.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 150 / 19
other
Total, other adverse events
0 / 150 / 19
serious
Total, serious adverse events
4 / 150 / 19

Outcome results

Primary

Change in Percent of Expected Lung Force Vital Capacity

Forced Vital Capacity (FVC) measures the ability of the lung to move air. The change in FVC was calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup.

Time frame: Baseline, and every 3 months up to 24 months

Population: Data for this measure were not collected for healthy controls.

ArmMeasureValue (MEAN)Dispersion
Veterans With ALSChange in Percent of Expected Lung Force Vital Capacity-1.25 % Expected Forced Vital CapacityStandard Deviation 7.05
Secondary

Change in Speech - as Measured by Speech Divergence

A measure looking at changes in vocal characteristics away from standard language. Speech Divergence is a novel calculated measure based on identifying changes to 13 characteristics of speech. The score can range from 0-13. Zero would represent normal speech, while 13 would be distorted speech along all parameters.

Time frame: Baseline, 3 Month intervals up to 24 months, calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup

Population: Speech Divergence is a novel calculated measure for this study based on change in vocal characteristics of 13 characteristics. Speech Divergence was not collected for the Healthy Controls.

ArmMeasureValue (MEAN)Dispersion
Veterans With ALSChange in Speech - as Measured by Speech Divergence1.88 score on a scaleStandard Deviation 1.4
Secondary

Change in Tongue Strength

A physiological measurement of tongue muscle strength, in multiple directions. A force measured with Iowa Oral Performance Instrument (IOPI)

Time frame: Baseline, 3 Month intervals up to 24 months, calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup

Population: Data for this measurement was only collected on the Veterans with ALS Arm. Data for this measure were not collected for healthy controls.

ArmMeasureValue (MEAN)Dispersion
Veterans With ALSChange in Tongue Strength-.625 kPaStandard Deviation 5.45

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026