Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease

February 7, 2019 updated by: Lawson Health Research Institute
This study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in Parkinson's disease. The procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. The device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in Parkinson's disease. The procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. The device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

Study Type

Interventional

Enrollment (Anticipated)

25

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 Contact

  • Name: Scott Adams, PhD
  • Phone Number: 88941 519-661-2111
  • Email: sadams@uwo.ca

Study Contact Backup

  • Name: Mandar Jog, MD
  • Phone Number: 519-663-3814

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6G 1H1
        • LawsonHRI
        • Contact:
          • Scott Adams, PhD
          • Phone Number: 88941 519-661-2111
          • Email: sadams@uwo.ca
        • Contact:
        • Principal Investigator:
          • Scott Adams, PhD
        • Sub-Investigator:
          • Mandar Jog, MD
        • Sub-Investigator:
          • Vijay Parsa, PhD
        • Sub-Investigator:
          • Daryn Cushnie-Sparrow, BSc

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

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with idiopathic Parkinson's disease and hypophonia by a neurologist at least 6 months prior to participation.
  • stabilized on antiparkinsonian medication.
  • good general health.
  • pass a 40 decibel hearing screening.
  • proficient enough in English to participate in speech testing.

Exclusion Criteria:

  • history of stroke or an additional neurological or motor control disorder.
  • history of speech impairment that is unrelated to Parkinson's disease.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Speech-to-noise feedback
A target speech-to-noise level is specified and feedback about achievement of the target level is provided
Behavioral: Speech-to-noise feedback
A target speech-to-noise level is specified and feedback about achievement of the target level is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average speech-to-noise ratio
Time Frame: Single two-hour visit.
Average speech-to-noise ratio value will be obtained over a two-hour interval.
Single two-hour visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Speech Intelligibility Score (PSIS)
Time Frame: Single two-hour visit.
PSIS is the percentage of words that can be correctly understood by a person listening (listener) to the participant's speech while they read sentences aloud. The PSIS ranges from 0% to 100%. This is a total score. Higher PSIS are considered better. The PSIS are obtained using communication partners (i.e. spouse) who listen and provide live repetitions of the spoken sentences. The spoken repetitions are transcribed by the investigators and compared to the printed reading material to calculate the percent of correctly transcribed words. The result is the PSIS referenced to a familiar listener (i.e. communication partner). The participant's spoken sentences are audio recorded and played to naïve listeners who provide written transcriptions of the participant's spoken sentences. The naïve listener transcribed sentences are compared to the printed reading material and the percent of correctly transcribed words is calculated. The result is the PSIS referenced to a naïve listener.
Single two-hour visit.
Ratings of Experience with the Device
Time Frame: Single two-hour visit.
Participants rate their device experience with 5 visual-analogue scales (VAS) for 5 parameters. Participants see a 10cm horizontal line with end points and place a vertical line for their rating. Left is a poorer rating and right is a better rating. Parameter 1 is 'physical comfort' with left as 'uncomfortable' and right as 'comfortable'. Parameter 2 is 'visual presentation' with left as 'unacceptable' and right as 'acceptable'. Parameter 3 is 'response to feedback' with 'bothersome' (left) and 'not bothersome' (right). Parameter 4 is 'speech intensity' with 'too quiet' (left) and 'too loud' (right). Parameter 5 is 'overall preference' with 'low preference' (left) and 'high preference' (right). Vertical lines placed on the VAS are measured by hand from the left end and expressed as percent of the total VAS line. The 5 device experience parameter ratings are expressed as separate percentage VAS scores and will not be used to calculate a total score.
Single two-hour visit.

Collaborators and Investigators

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

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Scott Adams, PhD, Western 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 (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LawsonHRI5264
  • 111861 (Other Identifier: Western University Health Sciences Research Ethics Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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