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

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.

Be older than 18 years old

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

No Placebo-Only Group

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.

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.

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, have a cochlear implant for at least a year, speak English, and can consent.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Electrode discrimination

Change in Pitch Scaling

Change in Sentence recognition

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met