460 Participants Needed

Cochlear Implants for Listening Effort in Cochlear Implant Users

Recruiting at 1 trial location
NC
MA
Overseen ByMario A. Svirsky, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how people with cochlear implants process speech in real-world settings. Researchers will study listening effort and comprehension by measuring the brain's work in understanding speech. The trial includes cochlear implant users and people with normal hearing to assess how different conditions affect listening. Good candidates for this trial are adults who have used a cochlear implant for at least a year and have no other significant health issues affecting hearing or comprehension. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance understanding and outcomes for cochlear implant users.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it excludes those taking medications that might interfere with task performance. It's best to discuss your specific medications with the trial team.

What prior data suggests that cochlear implants are safe for users?

Research has shown that cochlear implants are generally safe for people with severe hearing loss. These implants reliably help restore hearing. Most recipients do not experience serious side effects. However, some users find listening challenging and more effortful than for those with normal hearing, which can lead to tiredness. Despite this, the implants are not associated with dangerous health risks. Overall, cochlear implants are well-tolerated and improve hearing for many individuals.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how cochlear implants can impact listening effort in users. Unlike traditional hearing aids that amplify sound, cochlear implants bypass damaged parts of the ear and directly stimulate the auditory nerve, which can be especially beneficial for those with severe hearing loss. This trial also utilizes innovative pupillometry measurements to assess the cognitive load of listening, providing deeper insights into how cochlear implant users process speech compared to normal-hearing individuals. By understanding these dynamics, researchers aim to improve the design and functionality of cochlear implants, potentially enhancing the listening experience for users.

What evidence suggests that cochlear implants are effective for improving speech understanding in cochlear implant users?

Research has shown that cochlear implants can significantly aid people who are deaf in understanding speech in noisy environments. In this trial, cochlear implant users will complete behavioral speech perception and comprehension tasks to assess listening effort. One study found that users found it easier to listen when speakers slowed down. Another study discovered that speech recognition and memory skills can influence the effort required to understand speech. Cochlear implants are the only hearing aids that effectively improve speech understanding in noisy settings. Overall, these devices enhance speech comprehension and reduce mental fatigue during listening.36789

Who Is on the Research Team?

MA

Mario A. Svirsky, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with normal hearing or who use cochlear implants, without language disorders (except those related to hearing loss for CI users), neurological issues, psychiatric diseases, dementia, or medication that could affect task performance. Non-native speakers of American English and individuals under 18 are excluded.

Inclusion Criteria

I am between 18 and 80 years old with normal hearing or a cochlear implant.

Exclusion Criteria

Individuals with a history of language disorders (besides those associated with hearing loss for the CI users)
I have a condition or take medication that could affect my ability to perform tasks.
I am not a native American English speaker.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Comprehensive baseline battery to assess perceptual and cognitive abilities

1-2 weeks
1 visit (in-person)

Experiments

Participants complete six interconnected experiments measuring listening effort and comprehension

Up to 9 hours per experiment
Multiple visits (in-person)

Follow-up

Participants are monitored for outcomes related to speech comprehension and cognitive effort

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cochlear Implants

Trial Overview

The study tests how well cochlear implant users understand speech by conducting six experiments involving listening effort and discourse comprehension. It uses pupillometry to measure the cognitive load during these tasks in both CI users and people with normal hearing.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Cochlear Implant UsersExperimental Treatment6 Interventions
Group II: Normal-Hearing Controls (Vocoder Simulation)Active Control6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

Preferences and Listening Efficiency of Adults With Cochlear ...

Slower speaking rate reduces listening effort among listeners with cochlear implants. Ear & Hearing, 42, 584–595. [DOI] [PMC free article] ...

Listening Effort in Cochlear Implant Users: The Effect of ...

This study aimed to evaluate the effect of speech recognition performance, working memory capacity (WMC), and a noise reduction algorithm (NRA) on listening ...

NCT03212924 | Listening Effort in Cochlear Implant Users

The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users. The listening effort is measured with pupillometry, by monitoring ...

Auditory listening effort and reaction time: a comparative ...

Cochlear implant (CI) provision has been shown to be the only hearing rehabilitation option that can improve speech perception in noise and ...

Systematic Review of Auditory Training Outcomes in Adult ...

Systematic review of auditory training outcomes in adult cochlear implant recipients and meta-analysis of outcomes.

Listening effort and fatigue among cochlear implant users

24 studies were included and suggests that CI users experience higher levels of listening effort when compared to normal hearing controls.

Summary of Safety and Effectiveness Data (SSED)

Cochlear implantation is considered a reliable and safe procedure to restore auditory input in patients with bilateral moderate-to-profound ...

Slower Speaking Rate Reduces Listening Effort Among...

Slower Speaking Rate Reduces Listening Effort Among Listeners With Cochlear Implants. Winn, Matthew B.; Teece, Katherine H. Author Information.

Safety and outcomes of cochlear implantation in the elderly

Elderly patients with hearing loss may face unique issues related to listening effort and attention. Tun et al. (2009) suggest that older adults require ...