Hearing ImpairmentNCT04055987
Use of Electropalatography to Improve Speech Sound Production
A study testing Visual biofeedback, auditory feedback and models in people with Hearing Impairment, run by Molloy College.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Visual biofeedback, auditory feedback and models
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2019to 1 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals who do not meet this criteria will be excluded from the protocol.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Impairment
- Being tested
- Visual biofeedback, auditory feedback and models
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual biofeedback, auditory feedback and modelsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Congenitally deaf | Experimental | 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. Receives: Behavioral: Visual biofeedback, auditory feedback and models |
| Adventitiously deaf | Experimental | 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. Receives: Behavioral: Visual biofeedback, auditory feedback and models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Speech Intelligibility
Change from baseline in speech intelligibility within a 10 week period after exposed to visual display of speech sound production.
Measured: 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start30 Sep 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Why it stopped: PI retired and co investigator left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of hearing-impaired persons with cochlear implants.One group will have congenital hearing loss. The second group will include individuals with acquired hearing loss.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molloy College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane Saulle, Ph.D, Principal investigator, Molloy CollegeNancy McGarr, Ph.D., Principal investigator, Molloy College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055987
- Sponsor's protocol ID
- 04190121
- Status last verified
- Sep 2019
- First submitted
- 22 Apr 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12858839Byun 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.
PubMed 22442281Dagenais 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.
PubMed 8576412Dagenais 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.
PubMed 1787723Fabus, 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.
PubMed 6621010Fletcher 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.
PubMed 1956200Fletcher, 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.
PubMed 2072676Martin, 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.
PubMed 6645470McGarr, 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Electropalatography to Improve Speech Sound Production in Deaf Adults With Cochlear Implants
- ClinicalTrials.gov ID
- NCT04055987
- Acronym / sponsor ID
- 04190121
- Conditions
- Hearing Impairment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI retired and co investigator left institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Molloy CollegeUniversity, hospital or other
- Study start
- 30 Sep 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 14 Aug 2019 (actual)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of hearing-impaired persons with cochlear implants.One group will have congenital hearing loss. The second group will include individuals with acquired hearing loss.
| Arm | Type | Receives |
|---|---|---|
| Congenitally deaf | Experimental | Behavioral: Visual biofeedback, auditory feedback and modelsPrior 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. |
| Adventitiously deaf | Experimental | Behavioral: Visual biofeedback, auditory feedback and modelsPrior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals who do not meet this criteria will be excluded from the protocol.
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 |
|---|---|---|
| Visual biofeedback, auditory feedback and modelsThe 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. | Behavioural | Adventitiously deaf, Congenitally deaf |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- BackgroundBernhardt, 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.
- Background: PubMed 12858839Bernhardt 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.
- Background: PubMed 22442281Byun 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.
- Background: PubMed 8576412Dagenais 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.
- Background: PubMed 1787723Dagenais 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.
- BackgroundFabus, 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.
- Background: PubMed 6621010Fletcher 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.
- Background: PubMed 1956200Fletcher 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.
- BackgroundFletcher, 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.
- BackgroundGibbon, 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.
- BackgroundGoldman, R., & Goldman, F. M. (2000). Fristoe Test of Articulation. American Guidance Service.
- Background: PubMed 2072676Lane 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.
- Individual participant dataSharing planned: No
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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.
Diane Saulle, Ph.D principal investigator
Molloy College
Nancy McGarr, Ph.D. principal investigator
Molloy College
Questions about this trial
What is this clinical trial studying?
A study testing Visual biofeedback, auditory feedback and models in people with Hearing Impairment, run by Molloy College.
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 3 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: withdrawn, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Improved Speech Intelligibility (time frame: 10 weeks.). 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 NCT04055987, which also lists 21 linked publications.
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 30 Sep 2019.