NCT04055987

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

April 22, 2019

Last Update Submit

September 26, 2019

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (1)

  • Improved Speech Intelligibility

    Change from baseline in speech intelligibility within a 10 week period after exposed to visual display of speech sound production.

    10 weeks.

Study Arms (2)

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.

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.

Behavioral: Visual biofeedback, auditory feedback and models

Interventions

Visual biofeedback, auditory feedback and modelsBEHAVIORAL

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.

Adventitiously deafCongenitally deaf

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (21)

  • 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.

    BACKGROUND

  • 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.

    PMID: 12858839BACKGROUND

  • 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.

    PMID: 22442281BACKGROUND

  • 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.

    PMID: 8576412BACKGROUND

  • 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.

    PMID: 1787723BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 6621010BACKGROUND

  • 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.

    PMID: 1956200BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Goldman, R., & Goldman, F. M. (2000). Fristoe Test of Articulation. American Guidance Service.

    BACKGROUND

  • 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.

    PMID: 2072676BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 6645470BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 12945614BACKGROUND

  • 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.

    PMID: 9673223BACKGROUND

  • 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.

    BACKGROUND

  • 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/

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 2269726BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Interventions

Models, Biological

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative Techniques

Study Officials

  • Diane Saulle, Ph.D

    Molloy College

    PRINCIPAL INVESTIGATOR

  • Nancy McGarr, Ph.D.

    Molloy College

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2019

First Posted

August 14, 2019

Study Start

September 30, 2019

Primary Completion

April 30, 2020

Study Completion

June 1, 2020

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share