NCT06829420

Brief Summary

The goal of this clinical trial is to test the use of voice personalization through artificial intelligence (AI) voice cloning on speech entrainment tasks to improve language production of persons with aphasia (PWA). The main question the study aims to answer is: \- What is the impact of personalized voice on speech entrainment in PWA compared to traditional speech entrainment? Speech entrainment is a technique used by speech-language pathologists to improve the speech production of PWA. Traditionally, speech therapists act as the model for participants to speak along with to improve their speech production. This study proposes the use of one's own voice (digitally altered) to improve speech production. The study uses a mobile health approach to administer speech entrainment treatment through a mobile app.

  • Smartphones with the mobile app pre-installed will be mailed to participants at no cost.
  • Participants will complete treatment in the comfort of their homes.
  • The experimental treatments involve: mirror speech entrainment (speaking along to one's own voice) and traditional speech entrainment (speaking along to someone else's voice).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress45%
May 2025Aug 2027

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

February 11, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

AphasiaNonfluent aphasiaSpeech entrainmentSpeech synchronization

Outcome Measures

Primary Outcomes (1)

  • Speaking rate

    Language production as assessed by number of correct words produced per minute

    From enrollment to the end of treatment at 6 weeks

Study Arms (3)

Experiment 1: Feasibility Study

EXPERIMENTAL

Participants will receive two treatments sequentially: mirror speech entrainment using the auditory-only modality followed by mirror speech entrainment using the auditory-visual modality.

Behavioral: Mirror speech entrainment

Experiment 2: Mirror SE versus Traditional SE (Auditory-only)

EXPERIMENTAL

This arm investigates the use of mirror speech entrainment using auditory only feedback and traditional speech entrainment using auditory only feedback.

Behavioral: Mirror speech entrainmentBehavioral: Traditional speech entrainment: auditory-only

Experiment 3: Mirror SE versus Traditional SE (Auditory-visual)

EXPERIMENTAL

This arm will investigate the effect of mirror speech entrainment in the auditory-visual modality versus traditional speech entrainment in the auditory-visual modality.

Behavioral: Mirror speech entrainmentBehavioral: Traditional speech entrainment: auditory-visual

Interventions

Speech entrainment with the user's own voice using auditory-only and auditory-visual modalities.

Experiment 1: Feasibility StudyExperiment 2: Mirror SE versus Traditional SE (Auditory-only)Experiment 3: Mirror SE versus Traditional SE (Auditory-visual)

Traditional speech entrainment (speech entrainment using an external agent's voice) using the auditory-only modality (users only listen and speak along to auditory stimuli)

Experiment 2: Mirror SE versus Traditional SE (Auditory-only)

Traditional speech entrainment (speech entrainment using an external agent's voice) using the auditory-visual modality (users listen and speak along to both auditory and visual stimuli (mouth movements)

Experiment 3: Mirror SE versus Traditional SE (Auditory-visual)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between the ages of 18-70 years old
  • Dominant English-speaking
  • Aphasia due to left hemisphere stroke

You may not qualify if:

  • Individuals with aphasia due to other causes such as dementia, Alzheimer's disease and Parkinsonism
  • Non-dominant English adult speakers
  • Persons with significant difficulties with language comprehension
  • Persons with concomitant cognitive disability
  • Persons with uncorrected sensory deficits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Florida

Tampa, Florida, 33612, United States

NOT YET RECRUITING

University of South Florida

Tampa, Florida, 33614, United States

RECRUITING

MeSH Terms

Conditions

Aphasia, BrocaStrokeAphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Speech-language Pathologist

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will only be shared with approved members of the research team.

Locations