Articulation DisorderNCT02705326
Evaluating the Efficacy of Opti-Speech for Speech Treatment
A study testing Opti-Speech in people with Articulation Disorder and Dysarthria, run by Vulintus, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- Articulation Disorder, Dysarthria, Prelingual Deafness
- What is being tested?
- Opti-Speech
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive impairments that affect their ability to understand and follow instructions by the treating speech language pathologists
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Cleveland Hearing and Speech Center
Cleveland, Ohio, 44106
Callier Center for Communication Disorders at UT Dallas
Richardson, Texas, 75080
About this study
Official title: 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.
Read the 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.
- Conditions
- Articulation Disorder, Dysarthria, Prelingual Deafness
- Being tested
- Opti-Speech
- Medical subject headings
- Articulation Disorders, Dysarthria, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opti-SpeechDevice
Uses visual feedback of the tongue's motion to guide speech sound production
| Study group | Role | What they receive |
|---|---|---|
| Opti-Speech | Experimental | Speech treatment will be guided by Opti-Speech's visual feedback of tongue movement during speech Receives: Device: Opti-Speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 30 minutes of treatment
Secondary outcomes (1)
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
Measured: Immediately prior to first speech treatment and 2 months after final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Articulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vulintus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Callier Center for Communication Disorders, Cleveland Hearing and Speech Center, Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Jennell Vick, PhD, Principal investigator, Cleveland Hearing and Speech Center, Case Western Reserve UniversityThomas F Campbell, PhD, Principal investigator, Callier Center for Communication Disorders at UT DallasHolle L Carey, MS, Principal investigator, Vulintus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705326
- Sponsor's protocol ID
- VUL_2R44DC013467_OptiSpeech
- Other IDs
- 2R44DC013467
- Status last verified
- May 2018
- First submitted
- 1 Mar 2016
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26635571
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Opti-Speech, a 3D Visual Feedback System, for Speech Treatment
- ClinicalTrials.gov ID
- NCT02705326
- Acronym / sponsor ID
- VUL_2R44DC013467_OptiSpeech
- Conditions
- Articulation Disorder, Dysarthria, Prelingual Deafness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Vulintus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Callier Center for Communication Disorders, Cleveland Hearing and Speech Center, Case Western Reserve University
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opti-Speech | Experimental | Device: Opti-SpeechSpeech treatment will be guided by Opti-Speech's visual feedback of tongue movement during speech |
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Cognitive impairments that affect their ability to understand and follow instructions by the treating speech language pathologists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opti-SpeechUses visual feedback of the tongue's motion to guide speech sound production | Device | Opti-Speech |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Results publication: PubMed 26635571Katz 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.
- Opti-Speech DemoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Articulation Disorder
RecruitingPhase 2
Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice Trial
Speech Sound Disorder
Not yet recruiting
Deep Brain Stimulation + Therapy for Stroke
Stroke, Dysarthria
Recruiting
Voiceitt for People With Impairments in Speech
Speech Impairment, Speech Disorder
Recruiting
BiOfeedback, Online for Sibilant Treatment
Speech Sound Disorder
Recruiting
Online Rotating Delivery of Perception/Production Enhanced Treatment for Rhotics
Speech Sound Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennell Vick, PhD principal investigator
Cleveland Hearing and Speech Center, Case Western Reserve University
Thomas F Campbell, PhD principal investigator
Callier Center for Communication Disorders at UT Dallas
Holle L Carey, MS principal investigator
Vulintus, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opti-Speech in people with Articulation Disorder and Dysarthria, run by Vulintus, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent articulatory accuracy (time frame: within 30 minutes of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02705326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.