Parkinson DiseaseNCT04829006
Intelligibility Assessment for Parkinson's Disease
A study testing Understand Me For Life in people with Parkinson Disease, run by Long Island University at 1 site in United States.
Trial summary
The investigators aim at testing the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Understand Me For Life
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 4 Apr 2022
- Phase
- Interventional
- 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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a medical diagnosis of Parkinson's disease
- Have experienced changes in your voice (e.g., your voice has "lost its strength") and your voice is a current concern
- Have not received individual speech therapy for the past 2 years (group therapy is ok)
- Have a stable medication schedule
- Have not received DBS (Deep Brain Stimulation)
- Are a native speaker of American English
Show all 14Show fewer
- Be a native speaker of American English
- Have no history of neurological impairment
- Have no history of speech or language problems
- Be a native speaker of American English
- Be between 18-55 years old
- Have no history of speech-language-hearing problems
- Pass a free hearing screening
- Have received the Covid19 vaccine
Who cannot join
- If criteria above are not met
- Healthy controls:
- If criteria above are not met
- Listeners:
- If criteria above are not met
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automatic Assessment of Intelligibility in Individuals With Parkinson's Disease
The investigators aim at testing the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.
Read the detailed description
Close to 90% of people with Parkinson's disease develop voice problems during the course of the disease. These problems lead to reduced intelligibility, which entails a subsequent reduction in social participation and overall quality of life. The current study will focus on developing and pilot-testing an app to measure the intelligibility of people with PD and of healthy controls. In order to test the app's efficacy, speakers will read a set of 50 sentences that will be embedded in noise for measurement purposes. A group of listeners will also transcribe the spoken sentences to correlate their performance to that of the app. The ultimate purpose of this investigation is to improve self-monitoring and self-sufficiency in people with PD. The study is expected to last 12 months.
- Conditions
- Parkinson Disease
- Being tested
- Understand Me For Life
- Keywords
- intelligibility, voice disorders, dysarthria
- Medical subject headings
- Parkinson Disease, Voice Disorders, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Understand Me For LifeDevice
The aim of the current investigation is to test the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.
| Study group | Role | What they receive |
|---|---|---|
| Speakers | Other | Participants will be recording sentences using a customized app, which is the focus of the current investigation. There is no arm per se, as the current investigation does not involve an intervention. The current investigation aims at developing and pilot testing an app. Receives: Device: Understand Me For Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcription scores
Percent of words correctly transcribed
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Long Island University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gemma Moya Gale, Long Island University
- Investigators
- Gemma Moya Gale, Ph.D., Principal investigator, Long Island University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829006
- Sponsor's protocol ID
- 21/01-002
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Assessment of Intelligibility in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04829006
- Acronym / sponsor ID
- 21/01-002
- Conditions
- Parkinson Disease
- Keywords
- intelligibility, voice disorders, dysarthria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Long Island UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 2 Apr 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 aim at testing the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.
Detailed description
Close to 90% of people with Parkinson's disease develop voice problems during the course of the disease. These problems lead to reduced intelligibility, which entails a subsequent reduction in social participation and overall quality of life. The current study will focus on developing and pilot-testing an app to measure the intelligibility of people with PD and of healthy controls. In order to test the app's efficacy, speakers will read a set of 50 sentences that will be embedded in noise for measurement purposes. A group of listeners will also transcribe the spoken sentences to correlate their performance to that of the app. The ultimate purpose of this investigation is to improve self-monitoring and self-sufficiency in people with PD. The study is expected to last 12 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Speakers | Other | Device: Understand Me For LifeParticipants will be recording sentences using a customized app, which is the focus of the current investigation. There is no arm per se, as the current investigation does not involve an intervention. The current investigation aims at developing and pilot testing an app. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a medical diagnosis of Parkinson's disease
- Have experienced changes in your voice (e.g., your voice has "lost its strength") and your voice is a current concern
- Have not received individual speech therapy for the past 2 years (group therapy is ok)
- Have a stable medication schedule
- Have not received DBS (Deep Brain Stimulation)
Key exclusion criteria (5 listed)
- If criteria above are not met
- If criteria above are not met
- If criteria above are not met
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 |
|---|---|---|
| Understand Me For LifeThe aim of the current investigation is to test the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls. | Device | Speakers |
Primary outcome
Transcription scores
Time frame: 30 minutes
Percent of words correctly transcribed
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 12 Apr 2022.
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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.
Gemma Moya Gale, Ph.D. principal investigator
Long Island University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Understand Me For Life in people with Parkinson Disease, run by Long Island University 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 5 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 12 Apr 2022. 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?
Transcription scores (time frame: 30 minutes). 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 12 Apr 2022.