Study Stopped
PI change of institution
Role of the Auditory Efferent System in Auditory Perceptual Learning
2 other identifiers
interventional
28
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
1 active site
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
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedStudy Start
First participant enrolled
March 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2017
CompletedResults Posted
Study results publicly available
January 2, 2018
CompletedJanuary 5, 2018
December 1, 2017
1.1 years
October 8, 2015
October 31, 2017
December 29, 2017
Conditions
Keywords
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
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONParticipants 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 INTERVENTIONParticipants 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.
Eligibility Criteria
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
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: 8113128BACKGROUNDde 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: 18463246BACKGROUNDGoodman 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: 23982894BACKGROUNDGuinan 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: 17086072BACKGROUNDMertes 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: 26583481BACKGROUNDMertes 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: 27914370BACKGROUNDMiller 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: 20209044BACKGROUNDMertes 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.
PMID: 29135685RESULT
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
- PRINCIPAL INVESTIGATOR
Ian B Mertes, PhD, AuD
Loma Linda Veterans Association for Research and Education
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