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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Western Ontario, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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