NCT07599696

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
25mo left

Started Mar 2024

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Mar 2024May 2028

Study Start

First participant enrolled

March 1, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3.8 years

First QC Date

May 5, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

speechParkinson's diseaseatypical parkinsonismspeech acousticsspeech-language pathologyhypophoniavoicevoice disordersspeech disordersdysarthria

Outcome Measures

Primary Outcomes (3)

  • Speech intensity

    Decibel sound pressure level (dB SPL) measured from speech audio recordings

    Day 1

  • Voice quality

    Cepstral peak prominence smoothed (CPPS), measured in decibels (dB) from speech audio recordings

    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.

    Day 1

Secondary Outcomes (2)

  • Speech intelligibility

    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

    From end of speech study enrollment to within 1 year. Listener effort will be elicited from naive listeners following the speech recording study.

Study Arms (1)

Speech Study

EXPERIMENTAL

Single arm study: All speech conditions are administered.

Behavioral: Behavioral speech strategies + speech amplification

Interventions

Behavioral speech strategies + speech amplification

Speech Study

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48823, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseSpeechVoice DisordersSpeech DisordersDysarthria

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesVerbal BehaviorCommunicationBehaviorLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsArticulation Disorders

Central Study Contacts

Thea Knowles, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 20, 2026

Study Start

March 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations