Early Cochlear Implant Use
2 other identifiers
observational
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2025
Typical duration for all trials
1 active site
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
June 11, 2025
CompletedFirst Submitted
Initial submission to the registry
August 4, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
August 11, 2025
August 1, 2025
1.9 years
August 4, 2025
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in percentage of correct responses during speech perception tests
Speech perception tests involves presentation of a speech stimulus (may be a word, sentence, nonsense words, or other speech sounds) and subjects will have to indicate what they heard. The total score is the percentage of speech stimulus correctly understood, ranging from 0-100%.
Baseline, 1 year
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
The population includes hearing impaired adults. Both genders will be recruited. All subjects will be recruited from the NYU Cochlear Implant Clinic.
You may qualify if:
- Postlingually deaf cochlear implant users
- severe or profound hearing loss
- who do not have other diagnoses communicative or cognitive disorders.
- Test population: no prior experience with cochlear implants (recruitment happens prior to cochlear implantation).
- 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.
You may not qualify if:
- Diagnosed cognitive or communicative disorders (other than deafness)
- Below 18 years of age
- Above the age of 85 years old.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Mario A. Svirsky, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2025
First Posted
August 11, 2025
Study Start
June 11, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to ariel.hight@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to:ariel.hight@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.