NCT02705326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 31, 2018

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

March 1, 2016

Last Update Submit

December 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (1)

Opti-Speech

EXPERIMENTAL

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

Device: Opti-Speech

Interventions

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

Opti-Speech

Eligibility Criteria

Age12 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Cognitive impairments that affect their ability to understand and follow instructions by the treating speech language pathologists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Cleveland Hearing and Speech Center

Cleveland, Ohio, 44106, United States

Location

Callier Center for Communication Disorders at UT Dallas

Richardson, Texas, 75080, United States

Location

Related 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.

Related Links

MeSH Terms

Conditions

Articulation DisordersDysarthriaDeafness

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation Disorders

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 10, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

December 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations