- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07599696
Speech Amplification Devices for Parkinson Disease: Talker- and Technology-Driven Enhancements
May 14, 2026 updated by: Thea Knowles, Michigan State University
Speech Amplification Devices for Parkinson and Related Diseases: Talker- and Technology-Driven Enhancements
The proposed research aims to investigate the use of speech amplification devices as a potential treatment option for people with Parkinson's disease and related disorders who exhibit hypophonia, a voice disorder that affects over half of those with Parkinson's disease.
By characterizing the acoustic and perceptual effects of speech amplification and identifying ways to optimize outcomes through talker- and device-specific enhancements, this project seeks to develop personalized, evidence-based treatment options for hypophonia.
The current proposal will move this effort forward by systematically eliciting and modifying speech amplification device output that leverage both behavioral and technological approaches.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Though intensive behavioral speech intervention is considered the "gold standard" for treating hypophonia in Parkinson's disease (PD), many individuals struggle to transfer or maintain these behavioral strategies into their daily communication.
This is because PD, affecting over six million people worldwide, is a progressive, neurodegenerative disorder that also impairs cognition, sensorimotor integration, and fatigue.
Speech amplification devices are a type of augmentative technology that have been shown to improve communication related outcomes in PD.
Amplification devices increase the volume of a person's natural speech and can be used on their own or to augment behavioral speech outcomes.
The specific acoustic mechanisms underlying these benefits are unknown, though previous evidence suggests that increased signal intensity alone is not responsible for improved auditory-perceptual outcomes.
The overall goal of this proposal is to identify the relationship between acoustic and perceptual consequences of amplification devices with and without the use of behavioral speech strategies.
Aim 1 of this proposal will quantify the acoustic and auditory-perceptual effects of speech amplification devices for talkers with PD.
In addition to using an amplification device, participants will speak with both their habitual speech style and a hyperarticulated, clear speech style.
Aim 2 will identify the contribution of resultant acoustic features as well as targeted acoustic enhancements that optimize intelligibility in amplified speech.
Acoustic modifications that impact the relative contributions of low to high frequency spectral energy will be made to a subset of the speech recordings from Aim 1.
These acoustic enhancements will serve to simulate potential technological improvements to amplification devices.
Naïve listeners will hear the speech recordings made in Aims 1 and 2 and will provide measures of listener accuracy and effort.
Improvements in speech intelligibility of amplified speech are hypothesized to be associated with acoustic measures that reflect relative greater high to low frequency components of the speech signal.
The most positive change is hypothesized to occur when talkers combine behavioral speech strategies with amplification compared to behavioral changes or amplified speech alone.
Furthermore, auditory-perceptual outcomes are hypothesized to improve following implementation signal enhancements that could be directly integrated into future amplification device development.
Collectively, this study will identify ways to maximize speech treatment outcomes of speech amplification devices through behavioral changes made by the talker or acoustic enhancements to the device output itself.
Results will guide behavioral treatment strategies and future device modifications that will improve the efficacy of speech amplifiers in this population.
This work is innovative for establishing ways to leverage behavioral speech strategies with advances in augmentative technology for PD.
It is theoretically significant for defining the role of spectral acoustics in auditory-perceptual outcomes in disordered speech.
It is clinically significant for advancing patient-centered augmentative speech treatment technology for PD.
Study Type
Interventional
Enrollment (Estimated)
100
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: Thea Knowles, PhD
- Phone Number: 517-353-6401
- Email: thea@msu.edu
Study Locations
-
-
Michigan
-
East Lansing, Michigan, United States, 48823
- Recruiting
- Michigan State University
-
Contact:
- Thea Knowles, PhD
- Phone Number: 517-353-6401
- Email: thea@msu.edu
-
Principal Investigator:
- Thea Knowles, PhD
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Dominant speakers of North American English
- Have received a neurologist's diagnosis of Parkinson disease or parkinsonism (e.g., PSP/MSA/PSP)
- Present with changes in their speech/voice
Exclusion Criteria:
- History of any other speech, language, or neurological concern other than Parkinson/parkinsonism.
- Uncorrected hearing loss that exceeds a threshold of 40 dB HL in more than one ear (as per baseline screening audiometry) and/or use of a cochlear implant.
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 Study
Single arm study: All speech conditions are administered.
|
Behavioral speech strategies + speech amplification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech intensity
Time Frame: Day 1
|
Decibel sound pressure level (dB SPL) measured from speech audio recordings
|
Day 1
|
|
Voice quality
Time Frame: Day 1
|
Cepstral peak prominence smoothed (CPPS), measured in decibels (dB) from speech audio recordings
|
Day 1
|
|
Articulation
Time Frame: Day 1
|
Quadrilateral vowel articulation index, measured as a composite of first and second formants in Herz (Hz) across four vowels in speech audio recordings.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech intelligibility
Time Frame: From end of speech study enrollment to within 1 year. Perceptual measures are elicited from naive listeners following the speech recording study.
|
% words correctly understood by naive listeners (0% = no words correctly transcribed; 100% = all words correctly transcribed).
Listener participants transcribe speech recorded by speaker participants.
|
From end of speech study enrollment to within 1 year. Perceptual measures are elicited from naive listeners following the speech recording study.
|
|
Perceived Listener Effort
Time Frame: From end of speech study enrollment to within 1 year. Listener effort will be elicited from naive listeners following the speech recording study.
|
% along a visual analogue scale (0 = "no effort required to understand the speech"; 100 = "maximal effort required to understand the speech").
Listener participants will rate speech recorded by speaker participants.
|
From end of speech study enrollment to within 1 year. Listener effort will be elicited from naive listeners following the speech recording study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 1, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
May 31, 2028
Study Registration Dates
First Submitted
May 5, 2026
First Submitted That Met QC Criteria
May 14, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Synucleinopathies
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Neurobehavioral Manifestations
- Neurodegenerative Diseases
- Otorhinolaryngologic Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Laryngeal Diseases
- Communication Disorders
- Language Disorders
- Articulation Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Communication
- Verbal Behavior
- Parkinson Disease
- Speech Disorders
- Voice Disorders
- Dysarthria
- Speech
Other Study ID Numbers
- 00008898
- R21DC021798 (U.S. NIH Grant/Contract)
- CurePSP CARES Grant - Knowles (Other Grant/Funding Number: CurePSP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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