NCT04708717

Brief Summary

The goal of this study is to improve music and speech perception for cochlear implant users. Presently, most cochlear implants discard the temporal fine structure of sound, which is information that is widely believed to contribute to both music and speech perception. The proposed work examines perceptual and physiological changes that occur once this information is provided to cochlear implant users in a clear and consistent manner.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

5.3 years

First QC Date

January 7, 2021

Last Update Submit

June 27, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Baseline electrode psychophysics prior to training.

    Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.

    Measure collected prior to training.

  • Midpoint electrode psychophysics.

    Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.

    Measure collected at 4-week midpoint during psychophysical training.

  • Endpoint electrode psychophysics.

    Just-noticeable difference for pitch ranking based on stimulation cues. Pitch discrimination will be measured as provided independently by place and rate of cochlear implant stimulation, as well as in combination. Stimuli will be dual-electrode pulse trains, which probe place-pitch perception with greater resolution than possible with single-electrode stimulation. Two-alternative forced-choice procedures will be used in which participants judge which of two stimuli is higher in pitch. Frequency discrimination will be measured near condition frequencies of 110, 220, 440, 880, and 1760 Hz for each of the 4 stimulation conditions (place, rate, combined). Adaptive procedures will be used to measure 75% discrimination accuracy.

    Measure collected at 8-week endpoint following psychophysical training.

Study Arms (2)

Stimulation Rate

EXPERIMENTAL
Behavioral: Stimulation RateBehavioral: Electrode Location

Electrode Location

ACTIVE COMPARATOR
Behavioral: Stimulation RateBehavioral: Electrode Location

Interventions

Psychophysical training listening to stimulation rate as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.

Electrode LocationStimulation Rate

Psychophysical training listening to electrode location as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.

Electrode LocationStimulation Rate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cochlear implant users.

You may not qualify if:

  • Younger than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 14, 2021

Study Start

September 1, 2020

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

July 2, 2025

Record last verified: 2025-06

Locations