NCT02574247

Brief Summary

The purpose of this study is to determine how changes in speech perception resulting from a computerized auditory training program are related to concurrent changes in auditory brainstem function resulting from the training. It is hypothesized that the degree of improvement in speech perception will be correlated with the degree of change in brainstem function.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

October 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

March 29, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 2, 2018

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

October 8, 2015

Results QC Date

October 31, 2017

Last Update Submit

December 29, 2017

Conditions

Keywords

AudiologyAuditory PathwaysAuditory PerceptionBrain StemCochleaEar, InnerEfferent PathwaysHair Cells, Auditory, OuterLearningNeurons, EfferentSpeech Perception

Outcome Measures

Primary Outcomes (2)

  • Change in Magnitude of Medial Olivocochlear Reflex Inhibition

    Decibel difference in medial olivocochlear reflex inhibition computed between final visit and baseline visit, where medial olivocochlear reflex inhibition is quantified as amplitude difference (in decibels) between transient-evoked otoacoustic emissions obtained with versus without broadband noise presented to the contralateral ear.

    First and last measurements (baseline and last session up to a year later)

  • Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks

    Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and performance (in percent correct) on Coordinate Response Measure (CRM) task and Institute of Electrical and Electronics Engineers (IEEE) sentences, each presented at two decibel signal-to-noise ratios (dB SNR). Results obtained at first study visit.

    Baseline (First study visit - 3 hour session)

Secondary Outcomes (2)

  • Change in Auditory Training Sentence Task Performance

    First and last measurements (baseline and last session up to a year later)

  • Change in Auditory Training Phoneme Task Performance

    First and last measurements (baseline and last session up to a year later)

Study Arms (3)

Training

EXPERIMENTAL

Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.

Procedure: Computerized auditory training

Control

NO INTERVENTION

Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.

Speech Group

NO INTERVENTION

Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.

Interventions

10 sessions of computerized auditory training (1.5 hr/session) across a 15-week span.

Training

Eligibility Criteria

Age35 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • frequency pure-tone average ≤40 decibels hearing level (dB HL)
  • Air-bone gaps ≤10 decibels (dB) from 500-4000 Hz
  • Hz tympanograms within normal limits
  • Measurable acoustic reflexes bilaterally
  • Measurable transient-evoked otoacoustic emissions
  • Ability to read and speak English
  • Ability to comply with all test procedures
  • Ability to commute to VA Loma Linda Healthcare System 12 times

You may not qualify if:

  • Hearing asymmetry \>15 decibels at three or more audiometric frequencies
  • Conductive hearing loss or otologic pathology
  • History of middle ear surgery
  • Chronic disease and/or use of medication that affects ability to participate in test procedures during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

Location

Related Publications (8)

  • Berlin CI, Hood LJ, Wen H, Szabo P, Cecola RP, Rigby P, Jackson DF. Contralateral suppression of non-linear click-evoked otoacoustic emissions. Hear Res. 1993 Dec;71(1-2):1-11. doi: 10.1016/0378-5955(93)90015-s.

    PMID: 8113128BACKGROUND
  • de Boer J, Thornton AR. Neural correlates of perceptual learning in the auditory brainstem: efferent activity predicts and reflects improvement at a speech-in-noise discrimination task. J Neurosci. 2008 May 7;28(19):4929-37. doi: 10.1523/JNEUROSCI.0902-08.2008.

    PMID: 18463246BACKGROUND
  • Goodman SS, Mertes IB, Lewis JD, Weissbeck DK. Medial olivocochlear-induced transient-evoked otoacoustic emission amplitude shifts in individual subjects. J Assoc Res Otolaryngol. 2013 Dec;14(6):829-42. doi: 10.1007/s10162-013-0409-9. Epub 2013 Aug 28.

    PMID: 23982894BACKGROUND
  • Guinan JJ Jr. Olivocochlear efferents: anatomy, physiology, function, and the measurement of efferent effects in humans. Ear Hear. 2006 Dec;27(6):589-607. doi: 10.1097/01.aud.0000240507.83072.e7.

    PMID: 17086072BACKGROUND
  • Mertes IB, Goodman SS. Within- and Across-Subject Variability of Repeated Measurements of Medial Olivocochlear-Induced Changes in Transient-Evoked Otoacoustic Emissions. Ear Hear. 2016 Mar-Apr;37(2):e72-84. doi: 10.1097/AUD.0000000000000244.

    PMID: 26583481BACKGROUND
  • Mertes IB, Leek MR. Concurrent measures of contralateral suppression of transient-evoked otoacoustic emissions and of auditory steady-state responses. J Acoust Soc Am. 2016 Sep;140(3):2027. doi: 10.1121/1.4962666.

    PMID: 27914370BACKGROUND
  • Miller JD, Watson CS, Kistler DJ, Preminger JE, Wark DJ. Training listeners to identify the sounds of speech: II. Using SPATS software. Hear J. 2008 Oct;61(10):29-33. doi: 10.1097/01.HJ.0000341756.80813.e1. No abstract available.

    PMID: 20209044BACKGROUND
  • Mertes IB, Wilbanks EC, Leek MR. Olivocochlear Efferent Activity Is Associated With the Slope of the Psychometric Function of Speech Recognition in Noise. Ear Hear. 2018 May/Jun;39(3):583-593. doi: 10.1097/AUD.0000000000000514.

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Dr. Ian Mertes
Organization
University of Illinois at Urbana-Champaign

Study Officials

  • Ian B Mertes, PhD, AuD

    Loma Linda Veterans Association for Research and Education

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 12, 2015

Study Start

March 29, 2016

Primary Completion

May 17, 2017

Study Completion

May 17, 2017

Last Updated

January 5, 2018

Results First Posted

January 2, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations