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Intelligibility Assessment for Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04829006
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Gemma Moya Gale, Long Island University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Understand Me For Life Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Automatic Assessment of Intelligibility in Individuals With Parkinson's Disease
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Speakers
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.
 Device: Understand Me For Life
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.


Outcome Measures
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Primary Outcome Measures :
  1. Transcription scores [ Time Frame: 30 minutes ]
    Percent of words correctly transcribed


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829006


Contacts
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Contact: Gemma Moya Gale, Ph.D. 718-780-4125 gemma.moya-gale@liu.edu
Contact: Alireza Goudarzi, Ph.D alireza.goudarzi@gmail.com

Locations
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United States, New York
Long Island University Recruiting
Brooklyn, New York, United States, 11201
Contact: Gemma Moya Gale, Ph.D.    718-780-4125    gemma.moya-gale@liu.edu   
Sponsors and Collaborators
Long Island University
Investigators
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Principal Investigator: Gemma Moya Gale, Ph.D. Long Island University
More Information
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Responsible Party: Gemma Moya Gale, Assistant Professor, CCC-SLP, Long Island University
ClinicalTrials.gov Identifier: NCT04829006    
Other Study ID Numbers: 21/01-002
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gemma Moya Gale, Long Island University:
intelligibility
voice disorders
dysarthria
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases