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DeafnessNCT03867032

Auditory Training With Speech Related Acoustic Cues Using Psychophysical Testing

A study testing Auditory training in people with Deafness, run by East Carolina University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for
Deafness
What is being tested?
Auditory training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2022to Jun 2023
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 10 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • None

About this study

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.

Conditions
Deafness
Being tested
Auditory training
Medical subject headings
Deafness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auditory trainingBehavioural

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

Study groups in NCT03867032
Study groupRoleWhat they receive
Cochlear implant usersExperimentalThe group will receive auditory training (psychophysical), and will be evaluated for speech recognition to determine the effect of training.
Receives: Behavioral: Auditory training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study startDec 2022 (estimated)
  3. Primary completion26 Dec 2022 (estimated)
  4. Study completionJun 2023 (estimated)

Why it stopped: PI passed away. Ending grant and closing down lab

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03867032
Sponsor's protocol ID
Zhou_R01_study5
Status last verified
Apr 2023
First submitted
5 Mar 2019
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19293398

  • 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.

    PubMed 25590651

  • 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.

    PubMed 25618067

  • 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.

    PubMed 20211951

  • 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.

    PubMed 28213134

  • 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.

    PubMed 16081006

  • 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.

    PubMed 21361447

  • 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.

    PubMed 25321148

  • 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.

    PubMed 23927116

  • 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.

    PubMed 23459244

  • 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.

    PubMed 19906958

  • 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.

    PubMed 21747773

  • 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.

    PubMed 16672673

  • 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.

    PubMed 24489819

  • 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.

    PubMed 22573676

Questions about this trial

What is this clinical trial studying?

A study testing Auditory training in people with Deafness, run by East Carolina University.

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 5 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 7 Apr 2023. 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?

speech recognition after training (time frame: starting 12 months after the award and will take up to 3.5 years to complete). 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 NCT03867032, which also lists 18 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 7 Apr 2023.

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