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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04829006
Other study ID # 21/01-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date April 4, 2022

Study information

Verified date April 2022
Source Long Island University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date April 4, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Long Island University Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
Long Island University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transcription scores Percent of words correctly transcribed 30 minutes
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