NCT04099368

Brief Summary

This project aims to characterize the emergence of music appreciation in people who have suffered hearing loss and have been provided with partial restoration of hearing through cochlear implantation. Music appreciation is complex and transverses multiple domains including hearing acuity, speech and language acquisition, and quality of life. By studying these relationships in people who have been given partial hearing restoration, the investigators will clarify the role of music for promoting recovery from debilitating loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 26, 2025

Status Verified

June 1, 2025

Enrollment Period

5.3 years

First QC Date

September 17, 2019

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pitch Discrimination measured using Psychophysical Procedures

    Change in auditory resolution of fundamental frequency is measured using psychophysical procedures.

    Measure collected at 0, 4, and 8 week mark to examine change in discrimination thresholds.

Secondary Outcomes (1)

  • Change in Speech Recognition Thresholds measured using Psychophysical Procedures

    Measure collected at 0, 4, and 8 week mark to examine change in speech recognition thresholds.

Study Arms (2)

Auditory

EXPERIMENTAL

Group receives training on listening to musical pitch differences between sounds as the first component of a crossover trial. The intervention is the listening exercises. Exercises are completed daily as 30-minute sessions for 4 weeks. Hearing assessment outcomes of speech comprehension in background noise and of musical pitch sensitivity are conducted at baseline and at midpoint and endpoint.

Behavioral: Musical pitch training

Visual

ACTIVE COMPARATOR

Group receives training on visual differences between objects on a computer screen as the first component of a crossover trial. This is a control measure for the auditory training exercises. Exercises are completed daily as 30-minute sessions for 4 weeks. Hearing assessment outcomes of speech comprehension in background noise and of musical pitch sensitivity are conducted at baseline and at midpoint and endpoint.

Behavioral: Musical pitch training

Interventions

Crossover design with one group receiving musical training as rehabilitation, second group receiving visual training first as a control rehabilitation.

Also known as: Auditory rehabilitation
AuditoryVisual

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teenage and adult cochlear implant users

You may not qualify if:

  • Children younger than 13

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

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

September 17, 2019

First Posted

September 23, 2019

Study Start

October 1, 2019

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

December 26, 2025

Record last verified: 2025-06

Locations