An observational study in Amyotrophic Lateral Sclerosis, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Milton S. Hershey Medical Center · Observational
The investigators propose a longitudinal home study of ALS patients to measure the severity of speech and swallowing (bulbar) impairment via a smartphone-based, remote speech and swallow assessment (rSSA). The study is designed to assess the feasibility and validity of such a monitoring intervention. Furthermore, it is proposed that regular monitoring of these two bulbar processes may shed light on their co-evolution over the course of ALS.
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.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's enrollment of 200 is above the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Population 1: Patients with ALS Population 2: Healthy Listeners
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients
Listeners
Exclusion Criteria:
Patients
Listeners
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Radiation: Modified Barium Swallow Study (MBSS) · Behavioral: Speech Intelligibility Test (SIT)
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
\[Patients only\] Weekly completion of audio recordings of speech and swallowing performed at home by the subject using the study smartphone application on their personal device.
\[Patients only\] MBSS is an instrumented evaluation of oropharyngeal swallowing function that is performed using videofluoroscopy.
Also known as: Videofluoroscopic Swallowing Study (VFSS)
\[Patients only\] The SIT is a standardized test for measuring speech intelligibility.
\[Listeners only\] Listeners will judge the intelligibility of speech recordings made by patients in the study.
Digital recording of speech and swallow
Audio recordings of speech tasks and spontaneous swallowing task
Time frame: weekly for 24 weeks
MBS Impairment Profile (MBSImp)
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.
Time frame: Weeks 0 and 24
Speech Intelligibility Task (SIT) Intelligibility listener scoring
Listeners will score the intelligibility of patient SIT recordings
Time frame: Weeks 0, 12, and 24
ALS Functional Rating Scale - Revised (ALSFRS-R)
ALS Specific Assessment of physical function ranging from 0-48, with 48 being normal function.
Time frame: Weeks 0, 12, and 24
Center for Neurological Study - Bulbar Function Scale (CNS-BFS)
Self-administered rating scale for speech (7-49) and salivation (7-35) functions, with high scores indicating impaired function.
Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24
Mann Assessment of Swallowing Ability (MASA)
A standard clinical swallowing assessment performed by the speech-language pathologist. Scores range from 38-200, with lower scores indicating higher impairment.
Time frame: Weeks 0, 12, and 24
EAT-10 Questionnaire
A self-reported assessment of eating and swallowing function. Scores range from 0-40, with higher scores indicating higher impairment.
Time frame: Weeks 0, 12, and 24
Forced Vital Capacity (FVC)
A standard clinical respiratory assessment of vital capacity
Time frame: Weeks 0, 12, and 24
Maximal Inspiratory Pressure (MIP)
A standard clinical respiratory assessment of inspiratory strength
Time frame: Weeks 0, 12, and 24
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Aug 2024, 31 months.
Of 127 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's 31 months is below that.
Counting every sponsor, half of 136 studies reached it within 64 months; a quarter within 29 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →
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