NCT04889898

Remote Speech and Swallowing Assessment in ALS

Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-08-31
• Completion: 2026-09-01
• First posted: 2021-05-17
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States