Back to resultsIntelligibility Assessment for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Understand Me For Life
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring intelligibility, voice disorders, dysarthria
Eligibility Criteria
Speakers with PD:
Inclusion Criteria:
- 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
Exclusion Criteria:
- If criteria above are not met
Healthy controls:
Inclusion Criteria:
- Be a native speaker of American English
- Have no history of neurological impairment
- Have no history of speech or language problems
Exclusion Criteria:
- If criteria above are not met
Listeners:
Inclusion Criteria:
- 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
Exclusion Criteria:
- If criteria above are not met
Sites / Locations
- Long Island University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Speakers
Arm Description
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.
Outcomes
Primary Outcome Measures
Transcription scores
Percent of words correctly transcribed
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04829006
Brief Title
Intelligibility Assessment for Parkinson's Disease
Official Title
Automatic Assessment of Intelligibility in Individuals With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Long Island University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
intelligibility, voice disorders, dysarthria
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Speakers
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Understand Me For Life
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transcription scores
Description
Percent of words correctly transcribed
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Speakers with PD:
Inclusion Criteria:
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
Exclusion Criteria:
If criteria above are not met
Healthy controls:
Inclusion Criteria:
Be a native speaker of American English
Have no history of neurological impairment
Have no history of speech or language problems
Exclusion Criteria:
If criteria above are not met
Listeners:
Inclusion Criteria:
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
Exclusion Criteria:
If criteria above are not met
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma Moya Gale, Ph.D.
Organizational Affiliation
Long Island University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intelligibility Assessment for Parkinson's Disease
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