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Evaluating the Efficacy of Opti-Speech for Speech Treatment

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ClinicalTrials.gov Identifier: NCT02705326
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Callier Center for Communication Disorders
Cleveland Hearing and Speech Center
Case Western Reserve University
Information provided by (Responsible Party):
Vulintus, Inc.

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.

Condition or disease Intervention/treatment Phase
Articulation Disorder Dysarthria Prelingual Deafness Device: Opti-Speech Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Opti-Speech, a 3D Visual Feedback System, for Speech Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705326


Contacts
Contact: Holle L Carey 844-668-6872 ext 703 holle@vulintus.com
Contact: Thomas F Campbell, PhD 214-905-3001 thomas.f.campbell@utdallas.edu

Locations
United States, Ohio
The Cleveland Hearing and Speech Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jennell Vick, PhD    216-368-3352    jvick@chsc.org   
Contact: Rebecca Mental       rlm142@case.edu   
United States, Texas
Callier Center for Communication Disorders at UT Dallas Recruiting
Richardson, Texas, United States, 75080
Contact: Thomas F Campbell, PhD    214-905-3001    thomas.f.campbell@utdallas.edu   
Sponsors and Collaborators
Vulintus, Inc.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Callier Center for Communication Disorders
Cleveland Hearing and Speech Center
Case Western Reserve University
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.

Additional Information:
Publications of Results:
Responsible Party: Vulintus, Inc.
ClinicalTrials.gov Identifier: NCT02705326     History of Changes
Other Study ID Numbers: VUL_2R44DC013467_OptiSpeech
2R44DC013467 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Deafness
Dysarthria
Articulation Disorders
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations