NCT04889898Completed
Remote Speech and Swallowing Assessment in ALS
Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 7 May 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Milton S. Hershey Medical Center
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT04889898
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 1 Jan 2022 to the primary completion date, 31 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Possess a co-existing neurological or psychiatric illness that, in the opinion of the study team, exclude the subject from participation
- Demonstrate clinically significant dementia, as determined by the ALS study neurologist
- Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis
- Listeners
- Have an identified speech, language, learning, or neurological disorders per self-report
- Experience communicating with people with motor speech disorders
Other
- Patients
Who the study is looking for
- Patients
- At least 18 years of age
- Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, or possible by El Escorial criteria \[35\])
- Have symptom onset within the last 3 years
- Demonstrate a score of 2 or 3 in either the speech (item #1) or swallowing (item #3) components of the ALSFRS-R at time of enrollment
- Demonstrate decline in bulbar function prior to enrollment, measured by a reduction of at least 1 point on either the speech or swallowing components of the ALSFRS-R in the 6 months prior to enrollment. If 6 months of data is not available, an estimate of the change in ALSFRS-R will be calculated from the time of symptom onset.
- Have a life expectancy ≥ 6 months as determined by the attending neurologist
- Be fluent in written and spoken English
- Possess a smartphone capable of running the study application
- Follow up in the Penn State Hershey multidisciplinary ALS clinic over next 6 months
- Be able to visit the study site for in-person procedures at weeks 0 and 24
- Listeners
- Between 18 and 40 years of age
- Native speakers of American English 2.3. Currently residing within the United States. 3.4. Hearing within normal limits, as defined by self report.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hershey Medical Center ALS Clinic Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.