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Can a phone app monitor ALS progression from home?

NCT ID NCT04889898

Knowledge-focused Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This study is testing whether a smartphone app can reliably track speech and swallowing problems in people with ALS. Participants will record their voice and swallowing sounds at home each week using the app. The goal is to see if this remote monitoring is feasible and accurate compared to clinic-based tests, which could help doctors better understand how the disease progresses over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
smartphone app for recording speech and swallow sounds
What this could lead to
If successful, this could provide a convenient way for doctors to monitor ALS progression from home, potentially reducing clinic visits.
What could go wrong
This is an early feasibility study, not a treatment trial. The app may not accurately measure disease changes, and results may not apply to all ALS patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

200 people

The number who actually took part.

Started

Jan 2022

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Population 1: Patients with ALS Population 2: Healthy Listeners

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients 1. At least 18 years of age 2. Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, or possible by El Escorial criteria \[35\]) 3. Have symptom onset within the last 3 years 4. 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 5. 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. 6. Have a life expectancy ≥ 6 months as determined by the attending neurologist 7. Be fluent in written and spoken English 8. Possess a smartphone capable of running the study application 9. Follow up in the Penn State Hershey multidisciplinary ALS clinic over next 6 months 10. Be able to visit the study site for in-person procedures at weeks 0 and 24 Listeners 1. Between 18 and 40 years of age 2. Native speakers of American English 2.3. Currently residing within the United States. 3.4. Hearing within normal limits, as defined by self report. Exclusion Criteria: Patients 1. Possess a co-existing neurological or psychiatric illness that, in the opinion of the study team, exclude the subject from participation 2. Demonstrate clinically significant dementia, as determined by the ALS study neurologist 3. Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis Listeners 1. Have an identified speech, language, learning, or neurological disorders per self-report 2. Experience communicating with people with motor speech disorders

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis Deglutition Disorders Dysarthria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

Contacts and locations

Locations

  • Hershey Medical Center ALS Clinic

    Hershey, Pennsylvania, 17033, United States

More trials for these conditions

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