NCT03867032

Brief Summary

In this study, the investigators will evaluate whether auditory training with speech-related acoustic features in psychophysical testing will help CI subjects improve speech recognition. The primary endpoint is the speech recognition measures.

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 Dec 2022

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withdrawn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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
3.7 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

25 days

First QC Date

March 5, 2019

Last Update Submit

April 6, 2023

Conditions

Deafness

Outcome Measures

Primary Outcomes (1)

  • speech recognition after training

    Subjects will be measured for their baseline speech recognition performance (A) and then measured again for speech recognition after receiving auditory training using the psychophysical methods (B). Finally, the subjects will be measured for speech recognition the third time after the training is withdrawn following a ABA longitudinal design.

    starting 12 months after the award and will take up to 3.5 years to complete

Study Arms (1)

Cochlear implant users

EXPERIMENTAL

The group will receive auditory training (psychophysical), and will be evaluated for speech recognition to determine the effect of training.

Behavioral: Auditory training

Interventions

Auditory trainingBEHAVIORAL

Training with psychophysical tests (amplitude modulation detection on single electrodes) for improving speech recognition

Cochlear implant users

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Native speakers of English
  • Cochlear Nucleus cochlear implant users or Advanced Bionics users
  • Postlingually deafened
  • Has had device experience for at least one year
  • Can be child or adult at the time of enrollment

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Banai K, Hornickel J, Skoe E, Nicol T, Zecker S, Kraus N. Reading and subcortical auditory function. Cereb Cortex. 2009 Nov;19(11):2699-707. doi: 10.1093/cercor/bhp024. Epub 2009 Mar 17.

    PMID: 19293398BACKGROUND

  • Baumann S, Joly O, Rees A, Petkov CI, Sun L, Thiele A, Griffiths TD. The topography of frequency and time representation in primate auditory cortices. Elife. 2015 Jan 15;4:e03256. doi: 10.7554/eLife.03256.

    PMID: 25590651BACKGROUND

  • Boebinger D, Evans S, Rosen S, Lima CF, Manly T, Scott SK. Musicians and non-musicians are equally adept at perceiving masked speech. J Acoust Soc Am. 2015 Jan;137(1):378-87. doi: 10.1121/1.4904537.

    PMID: 25618067BACKGROUND

  • Chen JK, Chuang AY, McMahon C, Hsieh JC, Tung TH, Li LP. Music training improves pitch perception in prelingually deafened children with cochlear implants. Pediatrics. 2010 Apr;125(4):e793-800. doi: 10.1542/peds.2008-3620. Epub 2010 Mar 8.

    PMID: 20211951BACKGROUND

  • Coffey EBJ, Mogilever NB, Zatorre RJ. Speech-in-noise perception in musicians: A review. Hear Res. 2017 Sep;352:49-69. doi: 10.1016/j.heares.2017.02.006. Epub 2017 Feb 14.

    PMID: 28213134BACKGROUND

  • Fritz J, Elhilali M, Shamma S. Active listening: task-dependent plasticity of spectrotemporal receptive fields in primary auditory cortex. Hear Res. 2005 Aug;206(1-2):159-76. doi: 10.1016/j.heares.2005.01.015.

    PMID: 16081006BACKGROUND

  • Fitzgerald MB, Wright BA. Perceptual learning and generalization resulting from training on an auditory amplitude-modulation detection task. J Acoust Soc Am. 2011 Feb;129(2):898-906. doi: 10.1121/1.3531841.

    PMID: 21361447BACKGROUND

  • Fu QJ, Galvin JJ 3rd, Wang X, Wu JL. Benefits of music training in mandarin-speaking pediatric cochlear implant users. J Speech Lang Hear Res. 2015 Feb;58(1):163-9. doi: 10.1044/2014_JSLHR-H-14-0127.

    PMID: 25321148BACKGROUND

  • Huyck JJ, Wright BA. Learning, worsening, and generalization in response to auditory perceptual training during adolescence. J Acoust Soc Am. 2013 Aug;134(2):1172-82. doi: 10.1121/1.4812258.

    PMID: 23927116BACKGROUND

  • Looi V, Gfeller K, Driscoll V. MUSIC APPRECIATION AND TRAINING FOR COCHLEAR IMPLANT RECIPIENTS: A REVIEW. Semin Hear. 2012 Nov 1;33(4):307-334. doi: 10.1055/s-0032-1329222. Epub 2012 Nov 19.

    PMID: 23459244BACKGROUND

  • Parbery-Clark A, Skoe E, Kraus N. Musical experience limits the degradative effects of background noise on the neural processing of sound. J Neurosci. 2009 Nov 11;29(45):14100-7. doi: 10.1523/JNEUROSCI.3256-09.2009.

    PMID: 19906958BACKGROUND

  • Patel AD. Why would Musical Training Benefit the Neural Encoding of Speech? The OPERA Hypothesis. Front Psychol. 2011 Jun 29;2:142. doi: 10.3389/fpsyg.2011.00142. eCollection 2011.

    PMID: 21747773BACKGROUND

  • Polley DB, Steinberg EE, Merzenich MM. Perceptual learning directs auditory cortical map reorganization through top-down influences. J Neurosci. 2006 May 3;26(18):4970-82. doi: 10.1523/JNEUROSCI.3771-05.2006.

    PMID: 16672673BACKGROUND

  • Ruggles DR, Freyman RL, Oxenham AJ. Influence of musical training on understanding voiced and whispered speech in noise. PLoS One. 2014 Jan 28;9(1):e86980. doi: 10.1371/journal.pone.0086980. eCollection 2014.

    PMID: 24489819BACKGROUND

  • Sabin AT, Eddins DA, Wright BA. Perceptual learning evidence for tuning to spectrotemporal modulation in the human auditory system. J Neurosci. 2012 May 9;32(19):6542-9. doi: 10.1523/JNEUROSCI.5732-11.2012.

    PMID: 22573676BACKGROUND

  • Szpiro SF, Wright BA, Carrasco M. Learning one task by interleaving practice with another task. Vision Res. 2014 Aug;101:118-24. doi: 10.1016/j.visres.2014.06.004. Epub 2014 Jun 21.

    PMID: 24959653BACKGROUND

  • Wright BA, Sabin AT, Zhang Y, Marrone N, Fitzgerald MB. Enhancing perceptual learning by combining practice with periods of additional sensory stimulation. J Neurosci. 2010 Sep 22;30(38):12868-77. doi: 10.1523/JNEUROSCI.0487-10.2010.

    PMID: 20861390BACKGROUND

  • Yucel E, Sennaroglu G, Belgin E. The family oriented musical training for children with cochlear implants: speech and musical perception results of two year follow-up. Int J Pediatr Otorhinolaryngol. 2009 Jul;73(7):1043-52. doi: 10.1016/j.ijporl.2009.04.009. Epub 2009 May 2.

    PMID: 19411117BACKGROUND

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 7, 2019

Study Start

December 1, 2022

Primary Completion

December 26, 2022

Study Completion

June 1, 2023

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share