- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055987
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
Withdrawn
Conditions
Intervention / Treatment
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
Interventional
Phase
- 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
Ages Eligible for Study
16 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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
Investigators
- 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
- Bernhardt, B. H., Loyst, D., Pichora-Fuller, K., & Williams, R. (2000). Speech production outcomes before and after palotometry for a child with a cochlear implant. Journal-Academy of Rehabilitative Audiology, 33, 11-38.
- Bernhardt B, Gick B, Bacsfalvi P, Ashdown J. Speech habilitation of hard of hearing adolescents using electropalatography and ultrasound as evaluated by trained listeners. Clin Linguist Phon. 2003 Apr-May;17(3):199-216. doi: 10.1080/0269920031000071451.
- Byun TM, Hitchcock ER. Investigating the use of traditional and spectral biofeedback approaches to intervention for /r/ misarticulation. Am J Speech Lang Pathol. 2012 Aug;21(3):207-21. doi: 10.1044/1058-0360(2012/11-0083). Epub 2012 Mar 21.
- Dagenais PA. Electropalatography in the treatment of articulation/phonological disorders. J Commun Disord. 1995 Dec;28(4):303-29. doi: 10.1016/0021-9924(95)00059-1.
- Dagenais PA, Critz-Crosby P. Consonant lingual-palatal contacts produced by normal-hearing and hearing-impaired children. J Speech Hear Res. 1991 Dec;34(6):1423-35. doi: 10.1044/jshr.3406.1423.
- Fabus, R., Raphael, L., Gatzonis, S., Dondorf, K., Giardina, K., Cron, S., & Badke, B. (2015). Preliminary case studies investigating the use of electropalatography (EPG) manufactured by CompleteSpeech® as a biofeedback tool in intervention. International Journal, 3(1), 11-23.
- Fletcher SG, Hasegawa A. Speech modification by a deaf child through dynamic orometric modeling and feedback. J Speech Hear Disord. 1983 May;48(2):178-85. doi: 10.1044/jshd.4802.178.
- Fletcher SG, Dagenais PA, Critz-Crosby P. Teaching consonants to profoundly hearing-impaired speakers using palatometry. J Speech Hear Res. 1991 Aug;34(4):929-42. doi: 10.1044/jshr.3404.929.
- Fletcher, S., Hasegawa, A., McCutcheon, M., & Gilliom, J. (1980). Use of linguapalatal contact patterns to modify articulation in a deaf adult. In D. L. McPherso (Ed.), Advances in prosthetic devices for the deaf: A technical workshop (pp.127-133). Rochester, MD: NTID Press.
- Gibbon, F., Stewart, F., Hardcastle, W. J., & Crampin, L. (1999). Widening access to electropalatography for children with persistent sound system disorders. American Journal of Speech-Language Pathology, 8(4), 319-334.
- Goldman, R., & Goldman, F. M. (2000). Fristoe Test of Articulation. American Guidance Service.
- Lane H, Perkell J, Svirsky M, Webster J. Changes in speech breathing following cochlear implant in postlingually deafened adults. J Speech Hear Res. 1991 Jun;34(3):526-33. doi: 10.1044/jshr.3403.526.
- Martin, K. L., Hirson, A., Herman, R., Thomas, J., & Pring, T. (2007). The efficacy of speech intervention using electropalatography with an 18-year-old deaf client: A single case study. Advances in Speech Language Pathology, 9(1), 46- 56.
- McGarr NS. The intelligibility of deaf speech to experienced and inexperienced listeners. J Speech Hear Res. 1983 Sep;26(3):451-8. doi: 10.1044/jshr.2603.451.
- McGarr, N. S., Raphael, L. J., Kolia, B., Vorperian, H. K., & Harris, K. (2004). Sibilant production in speakers who have hearing loss: Electropalatographic and perceptual evidence. The Volta Review, 104(3), 119.
- Pantelemidou V, Herman R, Thomas J. Efficacy of speech intervention using electropalatography with a cochlear implant user. Clin Linguist Phon. 2003 Jun-Aug;17(4-5):383-92. doi: 10.1080/0269920031000079958.
- Parsloe R. Use of the speech pattern audiometer and the electropalatograph to explore the speech production/perception relationship in a profoundly deaf child. Int J Lang Commun Disord. 1998 Jan-Mar;33(1):109-21. doi: 10.1080/136828298247947.
- Pratt, S. R. (2007). Using electropalatographic feedback to treat the speech of a child with severe-to-profound hearing loss. The Journal of Speech and Language Pathology-Applied Behavior Analysis, 2(2), 213.
- Shriberg, L. D. (1980). An intervention procedure for children with persistent /r/ errors. Language, Speech, and Hearing Services in Schools, 11(2), 102-110. SmartPalate Overview. (n.d.). Retrieved from http://completespeech.com/smartpalate/smartpalate_overview/
- Subtenly, J. D., Orlando, N. A., & Whitehead, R. L. (1981). Speech and voice characteristics of the deaf. Washington, DC: The Alexander Graham Bell Association of the Deaf.
- Waldstein RS. Effects of postlingual deafness on speech production: implications for the role of auditory feedback. J Acoust Soc Am. 1990 Nov;88(5):2099-114. doi: 10.1121/1.400107.
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)
September 30, 2019
Primary Completion (Anticipated)
April 30, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
April 22, 2019
First Submitted That Met QC Criteria
August 13, 2019
First Posted (Actual)
August 14, 2019
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 26, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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