Evaluation of a Speech-to-noise Feedback Device for Treatment of Hypophonia in Parkinson's Disease
2 other identifiers
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2018
CompletedFirst Posted
Study publicly available on registry
August 27, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 11, 2019
February 1, 2019
1.2 years
August 22, 2018
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Average speech-to-noise ratio
Average speech-to-noise ratio value will be obtained over a two-hour interval.
Single two-hour visit.
Secondary Outcomes (2)
Percent Speech Intelligibility Score (PSIS)
Single two-hour visit.
Ratings of Experience with the Device
Single two-hour visit.
Study Arms (1)
Speech-to-noise feedback
EXPERIMENTALA target speech-to-noise level is specified and feedback about achievement of the target level is provided
Interventions
A target speech-to-noise level is specified and feedback about achievement of the target level is provided.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- history of stroke or an additional neurological or motor control disorder.
- history of speech impairment that is unrelated to Parkinson's disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LawsonHRI
London, Ontario, N6G 1H1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Adams, PhD
Western University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2018
First Posted
August 27, 2018
Study Start
March 1, 2019
Primary Completion
April 30, 2020
Study Completion
December 31, 2020
Last Updated
February 11, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share