NCT02574247

Role of the Auditory Efferent System in Auditory Perceptual Learning

Terminated NA Results posted Last updated 5 January 2018

What this trial tests

NA trial testing Computerized auditory training in Auditory Training and Auditory Efferent System in 28 participants. Terminated before completion.

Timeline

29 March 2016

Primary endpoint
17 May 2017

17 May 2017

Quick facts

Lead sponsor	VA Loma Linda Health Care System
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	28
Start date	29 March 2016
Primary completion	17 May 2017
Estimated completion	17 May 2017
Sites	1 location across United States

Drugs / interventions tested

• Computerized auditory training

Conditions studied

• Auditory Training and Auditory Efferent System — all drugs for Auditory Training and Auditory Efferent System →

Sponsor

VA Loma Linda Health Care System — full company profile →

Who can join

Adults 35 to 89, any sex, with Auditory Training and Auditory Efferent System. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Magnitude of Medial Olivocochlear Reflex Inhibition Primary · First and last measurements (baseline and last session up to a year later)

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.

Group	Value	95% CI
Training	-0.82	-3.71 – -0.08
Control	-0.49	-1.23 – 0.49

Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks Primary · Baseline (First study visit - 3 hour session)

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.

CRM at -9 dB SNR

Group	Value	95% CI
Pooled Participant Data	-0.18

CRM at -6 dB SNR

Group	Value	95% CI
Pooled Participant Data	0.28

IEEE at -6 dB SNR

Group	Value	95% CI
Pooled Participant Data	-0.06

IEEE at -3 dB SNR

Group	Value	95% CI
Pooled Participant Data	0.45

Change in Auditory Training Sentence Task Performance Secondary · First and last measurements (baseline and last session up to a year later)

Difference in percent correct of auditory training sentences, computed between first and last measurements.

Group	Value	95% CI
Training	3	-2 – 12

Change in Auditory Training Phoneme Task Performance Secondary · First and last measurements (baseline and last session up to a year later)

Difference in signal-to-noise ratio (in decibels) on auditory training phoneme tasks (onsets, nuclei, and codas), computed between first and last measurement.

Onsets

Group	Value	95% CI
Training	-4.38	-22.98 – -1.99

Nuclei

Group	Value	95% CI
Training	-2.99	-6.14 – 2.83

Codas

Group	Value	95% CI
Training	-2.60	-10.99 – 10.37

Association Between Medial Olivocochlear Reflex Inhibition and Slope of the Psychometric Function of Untrained Speech Perception Tasks Secondary · Baseline (First study visit - 3 hour session)

Partial Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and slope of the psychometric function (in decibel per decibel) of untrained speech tasks (Coordinate Response Measure -- CRM; Institute of Electrical and Electronics Engineers -- IEEE) obtained from performance across two signal-to-noise ratios. Age and high-frequency pure-tone average were controlled for in this post-hoc analysis. Results obtained at first study visit.

CRM Slope

Group	Value	95% CI
Pooled Participant Data	0.59

IEEE Slope

Group	Value	95% CI
Pooled Participant Data	0.60

Adverse events — posted to ClinicalTrials.gov

Time frame: Through study completion, maximum of 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Training

Serious: 0/10 (0%)

Deaths: 0/10

Control

Serious: 0/8 (0%)

Deaths: 0/8

Speech Group

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	Training	Control	Speech Group
Gastrointestinal pain	Gastrointestinal disorders	—	—	—

Data from ClinicalTrials.gov NCT02574247 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Olivocochlear Efferent Activity Is Associated With the Slope of the Psychometric Function of Speech Recognition in Noise.
   Mertes IB, Wilbanks EC, Leek MR. · · 2018 · cited 22× · PMID 29135685 · DOI 10.1097/aud.0000000000000514