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Procedure

Computer-Guided Electrode Selection for Hearing Loss

N/A
Recruiting
Led By Elad Sagi, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal hearing subjects must be older than the age of 18, have no diagnosis of any other communicative or cognitive disorder, be English-speaking, and have willingness and ability to provide informed consent.
Cochlear implant subjects must be older than the age of 18, implanted unilaterally with CI with at least 1 year of experience, and have no diagnosis of any other communicative or cognitive disorder. They must also be English-speaking and have willingness and ability to provide informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit (day 0), visit 1 (day 1), visit 2 (day 2), visit 3 (6 weeks), visit 4 (12 weeks), visit 5 (18 weeks), visit 6 (24 weeks)
Awards & highlights

Study Summary

This trial is testing whether using a computer model to guide which combination of active electrodes to use for a specific patient will result in better speech understanding than the standard method.

Who is the study for?
This trial is for adults over 18 with hearing loss who have had a cochlear implant for at least one year. Participants must speak English, be able to give informed consent, and not have other communication or cognitive disorders.Check my eligibility
What is being tested?
The study is testing a computer model that suggests the best settings for cochlear implants in individuals. It aims to see if these personalized settings improve speech understanding more than standard settings do.See study design
What are the potential side effects?
Since this trial involves non-invasive computational modeling rather than drugs or surgery, traditional side effects are not expected. However, there may be minimal risks associated with changes to device programming.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18, speak English, have normal hearing, and can consent.
Select...
I am over 18, have a cochlear implant for at least a year, speak English, and can consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit (day 0), visit 1 (day 1), visit 2 (day 2), visit 3 (6 weeks), visit 4 (12 weeks), visit 5 (18 weeks), visit 6 (24 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit (day 0), visit 1 (day 1), visit 2 (day 2), visit 3 (6 weeks), visit 4 (12 weeks), visit 5 (18 weeks), visit 6 (24 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Electrode discrimination
Change in Pitch Scaling
Change in Sentence recognition
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cochlear implant subjectsExperimental Treatment1 Intervention
Participates in 7 visits over a six-month duration. Subjects will be given several tests that require them to listen to sounds presented to their cochlear implant and answer questions about those sounds.
Group II: Normal hearing subjectsActive Control1 Intervention
Participates in 1 visit lasting 3 hours. Will be given several tests that require you to listen to sounds and answer questions about those sounds. The sounds will be distorted in ways that approximate how a cochlear implant sounds.

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
327 Previous Clinical Trials
178,271 Total Patients Enrolled
54 Trials studying Hearing Loss
19,905 Patients Enrolled for Hearing Loss
NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
817,886 Total Patients Enrolled
14 Trials studying Hearing Loss
1,506 Patients Enrolled for Hearing Loss
Elad Sagi, MDPrincipal InvestigatorNYU Langone Health

Media Library

Hearing Loss Clinical Trial 2023: Cochlear implant Highlights & Side Effects. Trial Name: NCT05219474 — N/A
Cochlear implant (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05219474 — N/A
Hearing Loss Research Study Groups: Cochlear implant subjects, Normal hearing subjects

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this study open to minors?

"To be eligible for this trial, patients must be between 18 and 90 years of age. There are 49 studies that exclusively involve minors and 123 specifically tailored towards seniors."

Answered by AI

How many participants have enrolled in this medical study thus far?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is actively recruiting participants; it was posted on May 1st 2022 and last edited on August 5th 2022. A pool of 45 individuals are needed to be enlisted from a single medical centre for the study's completion."

Answered by AI

Are there currently spots available for enrolment in this trial?

"Affirmative. Clinicaltrials.gov states that this trial began recruiting on May 1st 2022 and is actively seeking 45 participants at a single site, with the information most recently updated on August 5th 2022."

Answered by AI

What criteria do individuals have to meet in order to participate in this research project?

"This medical trial requires 45 persons with hearing loss and aged 18 through 90. Applicants must have a Cochlear implant, be English-speaking, over 18 years of age, free from other communicative or cognitive disorders, willing to provide informed consent and either possess normal hearing ability or one year experience using their CI device."

Answered by AI
~2 spots leftby Apr 2024