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- Klinische proef NCT07599696
Speech Amplification Devices for Parkinson Disease: Talker- and Technology-Driven Enhancements
14 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Thea Knowles, PhD
- Telefoonnummer: 517-353-6401
- E-mail: thea@msu.edu
Studie Locaties
-
-
Michigan
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East Lansing, Michigan, Verenigde Staten, 48823
- Werving
- Michigan State University
-
Contact:
- Thea Knowles, PhD
- Telefoonnummer: 517-353-6401
- E-mail: thea@msu.edu
-
Hoofdonderzoeker:
- Thea Knowles, PhD
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Speech Study
Single arm study: All speech conditions are administered.
|
Behavioral speech strategies + speech amplification
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Speech intensity
Tijdsspanne: Day 1
|
Decibel sound pressure level (dB SPL) measured from speech audio recordings
|
Day 1
|
|
Voice quality
Tijdsspanne: Day 1
|
Cepstral peak prominence smoothed (CPPS), measured in decibels (dB) from speech audio recordings
|
Day 1
|
|
Articulation
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Speech intelligibility
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 maart 2024
Primaire voltooiing (Geschat)
31 december 2027
Studie voltooiing (Geschat)
31 mei 2028
Studieregistratiedata
Eerst ingediend
5 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
14 mei 2026
Eerst geplaatst (Werkelijk)
20 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
14 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Synucleïnopathieën
- Neurologische manifestaties
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Ziekten van de luchtwegen
- Neurologische gedragsmanifestaties
- Neurodegeneratieve ziekten
- KNO-ziekten
- Bewegingsstoornissen
- Parkinson-stoornissen
- Basale ganglia-ziekten
- Laryngeale ziekten
- Communicatiestoornissen
- Taalstoornissen
- Articulatiestoornissen
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Tekenen en symptomen
- Communicatie
- Verbaal gedrag
- Ziekte van Parkinson
- Spraakstoornissen
- Stemstoornissen
- Dysartrie
- Toespraak
Andere studie-ID-nummers
- 00008898
- R21DC021798 (Subsidie/contract van de Amerikaanse NIH)
- CurePSP CARES Grant - Knowles (Ander subsidie-/financieringsnummer: CurePSP)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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