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Evaluating the Efficacy of Opti-Speech for Speech Treatment

Primary Purpose

Articulation Disorder, Dysarthria, Prelingual Deafness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opti-Speech
Sponsored by
Vulintus, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Articulation Disorder

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Cleveland Hearing and Speech Center
  • Callier Center for Communication Disorders at UT Dallas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Opti-Speech

Arm Description

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

Outcomes

Primary Outcome Measures

Percent articulatory accuracy
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

Secondary Outcome Measures

Change in Accuracy of Speech Sound Production from Pre-Treatment to Post-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

Full Information

First Posted
March 1, 2016
Last Updated
December 27, 2018
Sponsor
Vulintus, Inc.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Callier Center for Communication Disorders, Cleveland Hearing and Speech Center, Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT02705326
Brief Title
Evaluating the Efficacy of Opti-Speech for Speech Treatment
Official Title
Evaluating the Efficacy of Opti-Speech, a 3D Visual Feedback System, for Speech Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vulintus, Inc.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Callier Center for Communication Disorders, Cleveland Hearing and Speech Center, Case Western Reserve University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articulation Disorder, Dysarthria, Prelingual Deafness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opti-Speech
Arm Type
Experimental
Arm Description
Speech treatment will be guided by Opti-Speech's visual feedback of tongue movement during speech
Intervention Type
Device
Intervention Name(s)
Opti-Speech
Intervention Description
Uses visual feedback of the tongue's motion to guide speech sound production
Primary Outcome Measure Information:
Title
Percent articulatory accuracy
Description
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
Time Frame
within 30 minutes of treatment
Secondary Outcome Measure Information:
Title
Change in Accuracy of Speech Sound Production from Pre-Treatment to Post-Treatment
Description
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
Time Frame
Immediately prior to first speech treatment and 2 months after final treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennell Vick, PhD
Organizational Affiliation
Cleveland Hearing and Speech Center, Case Western Reserve University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas F Campbell, PhD
Organizational Affiliation
Callier Center for Communication Disorders at UT Dallas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holle L Carey, MS
Organizational Affiliation
Vulintus, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Hearing and Speech Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Callier Center for Communication Disorders at UT Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26635571
Citation
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.
Results Reference
result
Links:
URL
http://www.vulintus.com/optispeech/
Description
Opti-Speech Demo

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Evaluating the Efficacy of Opti-Speech for Speech Treatment

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