Remote Speech and Swallowing Assessment in ALS

NCT04889898 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2025-10-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

BEHAVIORAL

Speech Intelligibility Test (SIT)

\[Patients only\] The SIT is a standardized test for measuring speech intelligibility.

BEHAVIORAL

SIT Scoring

\[Listeners only\] Listeners will judge the intelligibility of speech recordings made by patients in the study.

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER
  • Congressionally Directed Medical Research Programs

    collaborator FED
  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Andrew Geronimo, PhD · Penn State College of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-08-31
Completion
2026-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889898 on ClinicalTrials.gov