Evaluating the Efficacy of Opti-Speech for Speech Treatment

December 27, 2018 updated by: Vulintus, Inc.

Evaluating the Efficacy of Opti-Speech, a 3D Visual Feedback System, for Speech Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • The Cleveland Hearing and Speech Center
    • Texas
      • Richardson, Texas, United States, 75080
        • Callier Center for Communication Disorders at UT Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Opti-Speech
Speech treatment will be guided by Opti-Speech's visual feedback of tongue movement during speech
Device: Opti-Speech
Uses visual feedback of the tongue's motion to guide speech sound production

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent articulatory accuracy
Time Frame: within 30 minutes of treatment
Sound probe lists will be administered within 30 minutes of treatment. Probe lists will be scored as correct or incorrect. The percentage of probes correct will be calculated
within 30 minutes of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Accuracy of Speech Sound Production from Pre-Treatment to Post-Treatment
Time Frame: Immediately prior to first speech treatment and 2 months after final treatment.
The Goldman Fristoe Test of Articulation will be administered prior to any speech treatment with Opti-Speech and again 2 months after the final speech treatment session. The percentage of consonants correct (PCC) will be used to assess the change in accuracy of speech sound production from pre-treatment to post-treatment
Immediately prior to first speech treatment and 2 months after final treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vulintus, Inc.

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)
Case Western Reserve University
Callier Center for Communication Disorders
Cleveland Hearing and Speech Center

Investigators

  • Principal Investigator: Jennell Vick, PhD, Cleveland Hearing and Speech Center, Case Western Reserve University
  • Principal Investigator: Thomas F Campbell, PhD, Callier Center for Communication Disorders at UT Dallas
  • Principal Investigator: Holle L Carey, MS, Vulintus, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

December 31, 2018

Last Update Submitted That Met QC Criteria

December 27, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VUL_2R44DC013467_OptiSpeech
  • 2R44DC013467 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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