Intelligibility Assessment for Parkinson's Disease

April 4, 2022 updated by: Gemma Moya Gale, Long Island University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11201
        • Long Island University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcription scores
Time Frame: 30 minutes
Percent of words correctly transcribed
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Long Island University

Investigators

  • Principal Investigator: Gemma Moya Gale, Ph.D., Long Island University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

April 4, 2022

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/01-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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