Early Cochlear Implant Use

NCT ID: NCT07114744

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-11

Study Completion Date

2027-07-01

Brief Summary

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This observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Take-home computers and test-equipment will be sent home, and subjects will complete approximately 25 test sessions over the first 3 months of cochlea implant use. Then, subjects will be tested 3 more times in the laboratory until 1 year-post activation. The primary objective is to determine and quantify how sounds change and speech perception improves over the course of early cochlear implant use.

Detailed Description

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Conditions

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Cochlear Implant Users

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Newly Implanted Users

Participants have no prior experience with cochlear implants (recruitment happens prior to cochlear implantation) will complete at home testing (\~25 sessions) over \~3 months of implant use.

Take home tests

Intervention Type OTHER

These tests will test the discriminability of sounds that vary systematically along the frequency and temporal dimensions of sound. Over the course of the 3 months post-activation, subjects will self-complete "take-home" tests at location of their choosing. Each test session will include the entire test-battery will be repeated frequency as often as every day and then reducing frequency of testing corresponding to the rate of speech perception improvement.

Experienced Cochlear Implant Users

Participants who have used the same stimulation strategy since initial stimulation will complete at home testing (\~25 sessions) over \~3 months of implant use.

Take home tests

Intervention Type OTHER

These tests will test the discriminability of sounds that vary systematically along the frequency and temporal dimensions of sound. Over the course of the 3 months post-activation, subjects will self-complete "take-home" tests at location of their choosing. Each test session will include the entire test-battery will be repeated frequency as often as every day and then reducing frequency of testing corresponding to the rate of speech perception improvement.

Interventions

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Take home tests

These tests will test the discriminability of sounds that vary systematically along the frequency and temporal dimensions of sound. Over the course of the 3 months post-activation, subjects will self-complete "take-home" tests at location of their choosing. Each test session will include the entire test-battery will be repeated frequency as often as every day and then reducing frequency of testing corresponding to the rate of speech perception improvement.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Postlingually deaf cochlear implant users
2. severe or profound hearing loss
3. who do not have other diagnoses communicative or cognitive disorders.
4. Test population: no prior experience with cochlear implants (recruitment happens prior to cochlear implantation).
5. Control population: subjects who have used the same stimulation strategy since initial stimulation, who note no continuing improvements or changes with their devices with respect to speech comprehension.

Exclusion Criteria

1. Diagnosed cognitive or communicative disorders (other than deafness)
2. Below 18 years of age
3. Above the age of 85 years old.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mario A. Svirsky, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ariel E. Hight, PhD

Role: CONTACT

212-263-7217

Mario A. Svirsky, PhD

Role: CONTACT

212-263-7217

Other Identifiers

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K99DC021727

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-01603

Identifier Type: -

Identifier Source: org_study_id

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