MedDataX Logo

Evaluating the Efficacy of Opti-Speech for Speech Treatment

NCT ID: NCT02705326

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if feedback from a three-dimensional real-time visualization of the tongue, a program called Opti-Speech, can be used to improve speech.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants will be asked to complete the Goldman Fristoe Test of Articulation along with several other assessment tests. Then speech treatment, guided by Opti-Speech, will be provided to the participant for up to 10 treatment sessions. The participant will be asked to come back after the final treatment for a 2-month follow-up assessment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Articulation Disorder Dysarthria Prelingual Deafness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Opti-Speech

Speech treatment will be guided by Opti-Speech's visual feedback of tongue movement during speech

Group Type EXPERIMENTAL

Opti-Speech

Intervention Type DEVICE

Uses visual feedback of the tongue's motion to guide speech sound production

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Opti-Speech

Uses visual feedback of the tongue's motion to guide speech sound production

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* English speaking individuals with speech errors resulting from persistent speech sound disorder, individuals with dysarthria resulting from neurological disorders and individuals with pre-lingual or congenital deafness.

Exclusion Criteria

* Cognitive impairments that affect their ability to understand and follow instructions by the treating speech language pathologists
Minimum Eligible Age

12 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Callier Center for Communication Disorders

UNKNOWN

Sponsor Role collaborator

Cleveland Hearing and Speech Center

UNKNOWN

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

Vulintus, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennell Vick, PhD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Hearing and Speech Center, Case Western Reserve University

Thomas F Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Callier Center for Communication Disorders at UT Dallas

Holle L Carey, MS

Role: PRINCIPAL_INVESTIGATOR

Vulintus, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Cleveland Hearing and Speech Center

Cleveland, Ohio, United States

Site Status

Callier Center for Communication Disorders at UT Dallas

Richardson, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Katz WF, Mehta S. Visual Feedback of Tongue Movement for Novel Speech Sound Learning. Front Hum Neurosci. 2015 Nov 19;9:612. doi: 10.3389/fnhum.2015.00612. eCollection 2015.

Reference Type RESULT
PMID: 26635571 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.vulintus.com/optispeech/

Opti-Speech Demo

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2R44DC013467

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VUL_2R44DC013467_OptiSpeech

Identifier Type: -

Identifier Source: org_study_id