Use of Electropalatography to Improve Speech Sound Production

September 26, 2019 updated by: Molloy College

The Use of Electropalatography to Improve Speech Sound Production in Deaf Adults With Cochlear Implants

The purpose of this proposed study is to examine the benefits of using electropalatography (EPG) during speech therapy with adult individuals who are either congenitally deaf or adventitiously deaf and use a cochlear implant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It has been established in numerous research studies that there is a definitive link between speech perception and speech production, in that what one can perceive, one can produce. Hearing loss disrupts this link and while cochlear implants make a significant difference in perception of sound, adults who are deaf and receive a cochlear implant (CI) do not gain the same perceptual benefits as children who are deaf and are implanted at a young age. Thus, the speech production of the adult CI user is reported to be less intelligible. The purpose of this proposed study is to examine the benefits of using electropalatography (EPG) during speech therapy with adult individuals who are either congenitally deaf or adventitiously deaf and use a cochlear implant. The investigators have proposed to study 10 CI users (5 in each etiological group) who will undergo speech intelligibility testing, and receive speech therapy (1x/week for 10 weeks) using EPG that provides both visual (biofeedback) and auditory feedback. It is hypothesized that the biofeedback in addition to the auditory feedback from the CI will result in an increase in articulation skills and thus the speech intelligibility in these individuals will improve significantly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All participants in this study will be at least 3 years post-implant and they must use the implants consistently.
  • Participants who have adventitious/acquired hearing loss must have had normal hearing through their 18th year.
  • Participants with congenital hearing loss will have received oral or total communication education, worn hearing aids and consider themselves to be "oral deaf" adults.

Exclusion Criteria:

  • Individuals who do not meet this criteria will be excluded from the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Congenitally deaf
Prior and post speech training, participants will read aloud a standard paragraph (Rainbow passage), complete a traditional speech test (Goldman Fristoe Test of Articulation - 3) to assess the sounds of the English language in all word positions (initial, medial, final) and read a list of consonant-vowel-consonant (CVC) combinations. Individual treatment will be provided once a week for 10 consecutive weeks. Traditional speech intervention with visual biofeedback from the EPG will be used. Auditory feedback will be provided through the participants own cochlear implant.
Behavioral: Visual biofeedback, auditory feedback and models
The EPG software program allows the speech clinician to model and comment upon the visual patterns during tongue/palate contact and to replay the participant's production for additional correction or reinforcement productions. Auditory feedback will be used to facilitate participant's perception of differences in production.
Experimental: Adventitiously deaf
Prior and post speech training, participants will read aloud a standard paragraph (Rainbow passage), complete a traditional speech test (Goldman Fristoe Test of Articulation - 3) to assess the sounds of the English language in all word positions (initial, medial, final) and read a list of CVC combinations. Individual treatment will be provided once a week for 10 consecutive weeks. Traditional speech intervention with visual biofeedback from the EPG will be used. Auditory feedback will be provided through the participants own cochlear implant.
Behavioral: Visual biofeedback, auditory feedback and models
The EPG software program allows the speech clinician to model and comment upon the visual patterns during tongue/palate contact and to replay the participant's production for additional correction or reinforcement productions. Auditory feedback will be used to facilitate participant's perception of differences in production.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improved Speech Intelligibility
Time Frame: 10 weeks.
Change from baseline in speech intelligibility within a 10 week period after exposed to visual display of speech sound production.
10 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Molloy College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane Saulle, Ph.D, Molloy College
  • Principal Investigator: Nancy McGarr, Ph.D., Molloy College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04190121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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