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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Speech-to-noise feedback
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LawsonHRI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Speech-to-noise feedback

Arm Description

A target speech-to-noise level is specified and feedback about achievement of the target level is provided

Outcomes

Primary Outcome Measures

Average speech-to-noise ratio
Average speech-to-noise ratio value will be obtained over a two-hour interval.

Secondary Outcome Measures

Percent Speech Intelligibility Score (PSIS)
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.
Ratings of Experience with the Device
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.

Full Information

First Posted
August 22, 2018
Last Updated
February 7, 2019
Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03648749
Brief Title
Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease
Official Title
Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group will be studied during no intervention (no feedback about speech) and intervention (feedback about speech) phases.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Speech-to-noise feedback
Arm Type
Experimental
Arm Description
A target speech-to-noise level is specified and feedback about achievement of the target level is provided
Intervention Type
Behavioral
Intervention Name(s)
Speech-to-noise feedback
Intervention Description
A target speech-to-noise level is specified and feedback about achievement of the target level is provided.
Primary Outcome Measure Information:
Title
Average speech-to-noise ratio
Description
Average speech-to-noise ratio value will be obtained over a two-hour interval.
Time Frame
Single two-hour visit.
Secondary Outcome Measure Information:
Title
Percent Speech Intelligibility Score (PSIS)
Description
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.
Time Frame
Single two-hour visit.
Title
Ratings of Experience with the Device
Description
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.
Time Frame
Single two-hour visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Adams, PhD
Phone
519-661-2111
Ext
88941
Email
sadams@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mandar Jog, MD
Phone
519-663-3814
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Adams, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
LawsonHRI
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 1H1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Adams, PhD
Phone
519-661-2111
Ext
88941
Email
sadams@uwo.ca
First Name & Middle Initial & Last Name & Degree
David Hill, MD
Phone
519-646-6100
Ext
64672
Email
info@lawsonresearch.com
First Name & Middle Initial & Last Name & Degree
Scott Adams, PhD
First Name & Middle Initial & Last Name & Degree
Mandar Jog, MD
First Name & Middle Initial & Last Name & Degree
Vijay Parsa, PhD
First Name & Middle Initial & Last Name & Degree
Daryn Cushnie-Sparrow, BSc

12. IPD Sharing Statement

Plan to Share IPD
No

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

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