Remote Speech and Swallowing Assessment in ALS
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|ClinicalTrials.gov Identifier: NCT04889898|
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : February 22, 2022
|Condition or disease||Intervention/treatment|
|Amyotrophic Lateral Sclerosis||Device: Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone Radiation: Modified Barium Swallow Study (MBSS) Behavioral: Speech Intelligibility Test (SIT) Behavioral: SIT Scoring|
Most individuals with ALS experience bulbar function deterioration over the course of the disease which impacts their quality of life significantly. Furthermore, in some patients, bulbar symptoms are an initial presenting symptom of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery.
The investigators propose a longitudinal home study of ALS patients to assess bulbar progression via a smartphone-based, self-administered remote speech and swallow assessment (rSSA). The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS.
|Study Type :||Observational|
|Estimated Enrollment :||170 participants|
|Official Title:||Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS|
|Actual Study Start Date :||January 1, 2022|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
All ALS patients will be enrolled in this arm, which involves a combination of clinical and home-based assessments of speech and swallowing.
Device: Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone
[Patients only] Weekly completion of audio recordings of speech and swallowing performed at home by the subject using the study smartphone application on their personal device.
Radiation: Modified Barium Swallow Study (MBSS)
[Patients only] MBSS is an instrumented evaluation of oropharyngeal swallowing function that is performed using videofluoroscopy.
Other Name: Videofluoroscopic Swallowing Study (VFSS)
Behavioral: Speech Intelligibility Test (SIT)
[Patients only] The SIT is a standardized test for measuring speech intelligibility.
Healthy listeners will be recruited to listen to the audio recordings of patients in the study in order to judge the intelligibility of their speech.
Behavioral: SIT Scoring
[Listeners only] Listeners will judge the intelligibility of speech recordings made by patients in the study.
- Digital recording of speech and swallow [ Time Frame: weekly for 24 weeks ]Audio recordings of speech tasks and spontaneous swallowing task
- MBS Impairment Profile (MBSImp) [ Time Frame: Weeks 0 and 24 ]Standardized scoring for the MBSS in 17 domains. Domains are aggregated in to scores for Oral Impairment (0-22), Pharyngeal Impairment (0-29), and Esophageal Impairment (0-4), with higher scores indicating impaired function.
- Speech Intelligibility Task (SIT) Intelligibility listener scoring [ Time Frame: Weeks 0, 12, and 24 ]Listeners will score the intelligibility of patient SIT recordings
- ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: Weeks 0, 12, and 24 ]ALS Specific Assessment of physical function ranging from 0-48, with 48 being normal function.
- Center for Neurological Study - Bulbar Function Scale (CNS-BFS) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ]Self-administered rating scale for speech (7-49) and salivation (7-35) functions, with high scores indicating impaired function.
- Mann Assessment of Swallowing Ability (MASA) [ Time Frame: Weeks 0, 12, and 24 ]A standard clinical swallowing assessment performed by the speech-language pathologist. Scores range from 38-200, with lower scores indicating higher impairment.
- EAT-10 Questionnaire [ Time Frame: Weeks 0, 12, and 24 ]A self-reported assessment of eating and swallowing function. Scores range from 0-40, with higher scores indicating higher impairment.
- Forced Vital Capacity (FVC) [ Time Frame: Weeks 0, 12, and 24 ]A standard clinical respiratory assessment of vital capacity
- Maximal Inspiratory Pressure (MIP) [ Time Frame: Weeks 0, 12, and 24 ]A standard clinical respiratory assessment of inspiratory strength
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04889898
|Contact: Andrew Geronimo, PhD||717-531-0003 ext email@example.com|
|United States, Pennsylvania|
|Hershey Medical Center ALS Clinic||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Andrew Geronimo, PhD 717-531-0003 ext 282576 firstname.lastname@example.org|
|Principal Investigator:||Andrew Geronimo, PhD||Penn State College of Medicine|