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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02705326
Other study ID # VUL_2R44DC013467_OptiSpeech
Secondary ID 2R44DC013467
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date August 2018

Study information

Verified date May 2018
Source Vulintus, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years to 85 Years
Eligibility 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 Design


Intervention

Device:
Opti-Speech
Uses visual feedback of the tongue's motion to guide speech sound production

Locations

Country Name City State
United States The Cleveland Hearing and Speech Center Cleveland Ohio
United States Callier Center for Communication Disorders at UT Dallas Richardson Texas

Sponsors (5)

Lead Sponsor Collaborator
Vulintus, Inc. Callier Center for Communication Disorders, Case Western Reserve University, Cleveland Hearing and Speech Center, National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 within 30 minutes of treatment
Secondary 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 Immediately prior to first speech treatment and 2 months after final treatment.
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