Amyotrophic Lateral SclerosisNCT04889898
Remote Speech and Swallowing Assessment in ALS
An observational study of Amyotrophic Lateral Sclerosis, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone, Modified Barium Swallow Study (MBSS) and Speech Intelligibility Test (SIT)
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 25 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population 1: Patients with ALS Population 2: Healthy Listeners
Who may be able to join
- 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.
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- 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.
Who cannot join
- Patients
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hershey Medical Center ALS Clinic
Hershey, Pennsylvania, 17033
About this study
Official title: Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS
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.
Read the 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
- Being tested
- Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone, Modified Barium Swallow Study (MBSS), Speech Intelligibility Test (SIT), SIT Scoring
- Keywords
- telemonitoring, digital health, mobile health, dysphagia, dysarthria
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Deglutition Disorders, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphoneDevice
[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.
Modified Barium Swallow Study (MBSS)Radiation
Also called Videofluoroscopic Swallowing Study (VFSS)
[Patients only] MBSS is an instrumented evaluation of oropharyngeal swallowing function that is performed using videofluoroscopy.
Speech Intelligibility Test (SIT)Behavioural
[Patients only] The SIT is a standardized test for measuring speech intelligibility.
SIT ScoringBehavioural
[Listeners only] Listeners will judge the intelligibility of speech recordings made by patients in the study.
| Study group | Role | What they receive |
|---|---|---|
| ALS Patients | All ALS patients will be enrolled in this arm, which involves a combination of clinical and home-based assessments of speech and swallowing. Receives: 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) | |
| Listeners | 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. Receives: Behavioral: SIT Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital recording of speech and swallow
Audio recordings of speech tasks and spontaneous swallowing task
Measured: weekly for 24 weeks
Secondary outcomes (8)
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.
Measured: Weeks 0 and 24
Speech Intelligibility Task (SIT) Intelligibility listener scoring
Listeners will score the intelligibility of patient SIT recordings
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 0, 12, and 24
Forced Vital Capacity (FVC)
A standard clinical respiratory assessment of vital capacity
Measured: Weeks 0, 12, and 24
Maximal Inspiratory Pressure (MIP)
A standard clinical respiratory assessment of inspiratory strength
Measured: Weeks 0, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jan 2022
- Primary completion31 Aug 2024
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Andrew Geronimo, Milton S. Hershey Medical Center
- Investigators
- Andrew Geronimo, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889898
- Sponsor's protocol ID
- STUDY00016872
- Status last verified
- Jun 2026
- First submitted
- 7 May 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS
- ClinicalTrials.gov ID
- NCT04889898
- Acronym / sponsor ID
- STUDY00016872
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- telemonitoring, digital health, mobile health, dysphagia, dysarthria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Penn State University, Congressionally Directed Medical Research Programs
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS Patients | – | 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)All ALS patients will be enrolled in this arm, which involves a combination of clinical and home-based assessments of speech and swallowing. |
| Listeners | – | Behavioral: SIT ScoringHealthy listeners will be recruited to listen to the audio recordings of patients in the study in order to judge the intelligibility of their speech. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population 1: Patients with ALS Population 2: Healthy Listeners
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- Patients
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ALS Patients |
| Modified Barium Swallow Study (MBSS)Also: Videofluoroscopic Swallowing Study (VFSS)[Patients only] MBSS is an instrumented evaluation of oropharyngeal swallowing function that is performed using videofluoroscopy. | Radiation | ALS Patients |
| Speech Intelligibility Test (SIT)[Patients only] The SIT is a standardized test for measuring speech intelligibility. | Behavioural | ALS Patients |
| SIT Scoring[Listeners only] Listeners will judge the intelligibility of speech recordings made by patients in the study. | Behavioural | Listeners |
Primary outcome
Digital recording of speech and swallow
Time frame: weekly for 24 weeks
Audio recordings of speech tasks and spontaneous swallowing task
8 secondary outcomes
MBS Impairment Profile (MBSImp)
Time frame: Weeks 0 and 24
Speech Intelligibility Task (SIT) Intelligibility listener scoring
Time frame: Weeks 0, 12, and 24
ALS Functional Rating Scale - Revised (ALSFRS-R)
Time frame: Weeks 0, 12, and 24
Center for Neurological Study - Bulbar Function Scale (CNS-BFS)
Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24
Mann Assessment of Swallowing Ability (MASA)
Time frame: Weeks 0, 12, and 24
EAT-10 Questionnaire
Time frame: Weeks 0, 12, and 24
Forced Vital Capacity (FVC)
Time frame: Weeks 0, 12, and 24
Maximal Inspiratory Pressure (MIP)
Time frame: Weeks 0, 12, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Geronimo, PhD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital recording of speech and swallow (time frame: weekly for 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.