Parkinson DiseaseNCT07599696
Speech Amplification Devices for Parkinson Disease: Talker- and Technology-Driven Enhancements
A study testing Behavioral speech strategies + speech amplification in people with Parkinson Disease and Atypical Parkinsonism, run by Michigan State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease, Atypical Parkinsonism
- What is being tested?
- Behavioral speech strategies + speech amplification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michigan State University
East Lansing, Michigan, 48823
Thea Knowles, PhD, 517-353-6401, thea@msu.edu
Thea Knowles, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Atypical Parkinsonism
- Being tested
- Behavioral speech strategies + speech amplification
- Keywords
- speech, Parkinson's disease, atypical parkinsonism, speech acoustics, speech-language pathology, hypophonia, voice, voice disorders, speech disorders, dysarthria
- Medical subject headings
- Parkinson Disease, Speech, Voice Disorders, Speech Disorders, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral speech strategies + speech amplificationBehavioural
Behavioral speech strategies + speech amplification
| Study group | Role | What they receive |
|---|---|---|
| Speech Study | Experimental | Single arm study: All speech conditions are administered. Receives: Behavioral: Behavioral speech strategies + speech amplification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intensity
Decibel sound pressure level (dB SPL) measured from speech audio recordings
Measured: Day 1
Voice quality
Cepstral peak prominence smoothed (CPPS), measured in decibels (dB) from speech audio recordings
Measured: Day 1
Articulation
Quadrilateral vowel articulation index, measured as a composite of first and second formants in Herz (Hz) across four vowels in speech audio recordings.
Measured: Day 1
Secondary outcomes (2)
Speech intelligibility
% words correctly understood by naive listeners (0% = no words correctly transcribed; 100% = all words correctly transcribed). Listener participants transcribe speech recorded by speaker participants.
Measured: 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
% 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.
Measured: From end of speech study enrollment to within 1 year. Listener effort will be elicited from naive listeners following the speech recording study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Mar 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Thea Knowles, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599696
- Sponsor's protocol ID
- 00008898
- Other IDs
- R21DC021798, CurePSP CARES Grant - Knowles
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Amplification Devices for Parkinson and Related Diseases: Talker- and Technology-Driven Enhancements
- ClinicalTrials.gov ID
- NCT07599696
- Acronym / sponsor ID
- 00008898
- Conditions
- Parkinson Disease, Atypical Parkinsonism
- Keywords
- speech, Parkinson's disease, atypical parkinsonism, speech acoustics, speech-language pathology, hypophonia, voice, voice disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Speech Study | Experimental | Behavioral: Behavioral speech strategies + speech amplificationSingle arm study: All speech conditions are administered. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral speech strategies + speech amplificationBehavioral speech strategies + speech amplification | Behavioural | Speech Study |
Primary outcome
Speech intensity
Time frame: Day 1
Decibel sound pressure level (dB SPL) measured from speech audio recordings
Voice quality
Time frame: Day 1
Cepstral peak prominence smoothed (CPPS), measured in decibels (dB) from speech audio recordings
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Parkinson Disease
Enrolling by invitationObservational study
Genetic Studies of Lysosomal Storage Disorders
Lysosomal Storage Disorders, Gaucher Disease
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Active, not recruitingPhase 1/2
Repurposing Lithium for Parkinson's Disease: a RCT
Parkinson Disease
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral speech strategies + speech amplification in people with Parkinson Disease and Atypical Parkinsonism, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thea Knowles, PhD (517-353-6401, thea@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech intensity (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.