Listening Effort for Hearing Loss

Overseen By Katherine Teece, AuD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Eye disease, Language disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the effort required for people with hearing loss to listen and how it affects their daily lives. The study examines how using a cochlear implant changes listening effort, fatigue, and recovery time during normal activities. Participants will listen to and repeat sentences in a quiet booth while researchers track changes in pupil size to measure listening effort. The trial is open to adults who either have normal hearing or have used a cochlear implant for at least six months and can understand spoken English well. As an unphased trial, this study allows participants to contribute to important research that could improve the quality of life for individuals with hearing loss.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for participants?

Research shows that cochlear implants are generally well-tolerated. Studies have found that long-term users often experience improved hearing and quality of life. For example, individuals with hearing loss in one ear frequently report better speech understanding and sound localization.

Cochlear implants are considered safe for most people. If an implant requires replacement, studies indicate that hearing and speech can remain stable or even improve. While some risks exist with the surgery or device, these are usually minor and well-documented.

Overall, for those considering a clinical trial for cochlear implants, research suggests they are a safe and effective option for many with hearing loss. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how listening effort affects people with cochlear implants compared to those with typical hearing. Unlike many studies that focus solely on speech recognition accuracy, this trial also monitors changes in pupil size to understand listening effort, offering a new way to measure cognitive load during listening tasks. This could lead to better strategies for managing hearing loss by providing insights that go beyond just understanding words, aiming to improve overall listening experiences for users of cochlear implants.

What evidence suggests that this trial's treatments could be effective for reducing listening effort in people with hearing loss?

Research shows that cochlear implants, which participants in this trial may receive, help people with significant hearing loss hear better. Studies have found that those with cochlear implants not only hear more clearly but also experience an improved quality of life. A review of research involving children revealed that cochlear implants greatly enhanced their hearing and their perception of it. Cochlear implants are the go-to treatment for moderate to severe hearing loss, consistently showing positive results in many studies. These benefits suggest that cochlear implants can make listening easier, potentially reducing the mental strain and fatigue often associated with hearing loss. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with hearing loss, specifically those who use cochlear implants and struggle with the extra effort required to listen. The study seeks participants who experience fatigue or mental strain from listening.

Inclusion Criteria

Lack language-learning or other cognitive disabilities

I am fluent in North American English.

I am 55 or older with normal hearing for low and mid frequencies, and slightly reduced for high frequencies.

Exclusion Criteria

I cannot keep my eyes fixed on one spot.

I have an eye condition that affects how my pupils change size.

Lack of perceptual and productive fluency in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Speech Recognition Testing

Participants undergo speech recognition testing in a sound-attenuated booth, with pupil dilation monitored to assess listening effort

60-90 minutes per session

Multiple sessions

Non-auditory Tasks

Participants complete tasks such as the NASA TLX and NIH Toolbox Pattern Comparison Processing Speed Test to gauge subjective experience of effort

Varies per task

Follow-up

Participants are monitored for any changes in listening effort and speech intelligibility post-testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sentence Manipulations

Trial Overview The study focuses on how sentence manipulations can affect the listening effort of cochlear implant users. It aims to measure changes in effort during listening tasks and understand the impact of long-term cochlear implant use on this effort.

How Is the Trial Designed?

Group I: Cochlear implant participants Experimental Treatment 1 Intervention

Participants with cochlear implants. Speech recognition testing: Listening to and repeating speech in the free field in a sound-attenuated booth. We track percent-correct scores for whole sentences and words within each sentence. Changes in the participant's pupil size will be monitored by an Eyelink eye tracker placed 50 cm from the eyes. Phasic pupil dilations are linked with experiment timing landmarks interpreted as changes in listening effort.

Group II: Typical-hearing controls Active Control 1 Intervention

Typical-hearing controls. Speech recognition testing: Listening to and repeating speech in the free field in a sound-attenuated booth. We track percent-correct scores for whole sentences and words within each sentence. Changes in the participant's pupil size will be monitored by an Eyelink eye tracker placed 50 cm from the eyes. Phasic pupil dilations are linked with experiment timing landmarks interpreted as changes in listening effort.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Cochlear implant (CI) users require a better signal-to-noise ratio (about 4 dB for 50% speech recognition and 5 dB for 80%) compared to normal-hearing (NH) listeners to achieve similar speech recognition performance, indicating that CI users face more challenges in noisy environments.

Despite these challenges, when matched for speech intelligibility, both CI users and NH listeners showed no significant differences in listening effort, suggesting that the effort required to understand speech is comparable between the two groups at similar performance levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech Recognition and Listening Effort in Cochlear Implant Recipients and Normal-Hearing Listeners. Abdel-Latif, KHA., Meister, H.[2022]

Cochlear implants significantly reduce perceived listening effort in both adults and children with unilateral or asymmetric hearing loss, as shown by a study involving 40 adults and 16 children who reported improvements within months of receiving their implants.

For adults with unilateral hearing loss, the reduction in listening effort was notably correlated with better speech recognition in noisy environments after 12 months, highlighting the practical benefits of cochlear implantation beyond just sound perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Cochlear Implant Use on Perceived Listening Effort in Adult and Pediatric Cases of Unilateral and Asymmetric Hearing Loss. Lopez, EM., Dillon, MT., Park, LR., et al.[2023]

Intraoperative evoked auditory brainstem responses (EABRs) in adult Evo®-cochlear implant recipients showed significant correlations with behavioral thresholds and comfort levels, indicating their reliability for setting sound processor activation levels.

The study found a notable correlation between the interpeak III-V interval from EABRs and sentence recognition scores after six months of device use, suggesting that EABRs can help predict and enhance auditory performance in cochlear implant users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implications of intraoperative eABRs to the Evo®-CI electrode array recipients. Danieli, F., Reis, ACMB., Massuda, ET., et al.[2022]

Cochlear implant (CI) recipients who lost low-frequency acoustic hearing showed significant improvement in speech recognition after activation, regardless of their preoperative hearing status, based on a study of 113 patients over a 24-month period.

Factors such as age at implantation and the length of the electrode array influenced post-activation performance, with older adults using mid/short arrays performing worse than younger adults with longer arrays, highlighting the importance of personalized device selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variables Affecting Cochlear Implant Performance After Loss of Residual Hearing. Thompson, NJ., Dillon, MT., Nix, EP., et al.[2023]

Very early bilateral cochlear implantation can significantly reduce the effort needed to acquire spoken language, potentially improving quality of life for children with hearing loss.

Despite early intervention, children with cochlear implants still face challenges in auditory and communicative outcomes compared to hearing children, largely due to increased listening effort and fatigue, which can hinder language processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary Approaches to the Study of Listening Effort in Young Children with Cochlear Implants. Saksida, A., Ghiselli, S., Bembich, S., et al.[2022]

Research involving cochlear-implant users must prioritize safety by preventing biological damage, avoiding uncomfortable sound levels, and ensuring user control over stimuli, as highlighted by best-practice recommendations.

Future studies should focus on understanding the biological effects of electrical stimulation from cochlear implants, particularly regarding the potential for damage when the implant is not in direct contact with neural tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Research Interfaces for Psychophysical Studies With Cochlear-Implant Users. Litovsky, RY., Goupell, MJ., Kan, A., et al.[2019]

A qualitative study involving 17 adults with severe-profound hearing loss revealed that listening effort is a complex experience influenced by social connectedness and the mental energy required to process sounds, especially before cochlear implantation.

Participants noted that while cochlear implants improved their ability to hear, they still required significant listening effort, which was linked to their social interactions and overall quality of life, highlighting the need for a new patient-reported outcome measure to assess listening effort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Connectedness and Perceived Listening Effort in Adult Cochlear Implant Users: A Grounded Theory to Establish Content Validity for a New Patient-Reported Outcome Measure. Hughes, SE., Hutchings, HA., Rapport, FL., et al.[2019]

Cochlear implant (CI) listeners show significant variability in sentence recognition scores, with factors like the etiology of hearing loss and duration of deafness accounting for about 40% of the differences in early performance, while electrode position factors contribute an additional 20%.

Optimal insertion depths of around 300° to 400° are associated with the highest initial sentence recognition scores, suggesting that proper electrode placement is crucial for maximizing the effectiveness of cochlear implants in both quiet and noisy environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Sentence Recognition in Adult Cochlear Implant Users. James, CJ., Karoui, C., Laborde, ML., et al.[2020]

In a study of 72 adult cochlear implant users (34 with bilateral implants and 38 with unilateral implants), it was found that bilateral cochlear implants significantly reduce self-reported listening effort in various situations compared to unilateral implants.

While the difference in listening effort between bilateral and unilateral CI users was statistically significant, the overall effect was modest, indicating that while bilateral implants are beneficial, the improvement in listening effort may not be very large.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Listening effort with cochlear implants: Unilateral versus bilateral use]. Schnabl, J., Bumann, B., Rehbein, M., et al.[2018]

This study introduces a new evaluation protocol for research platforms (RPs) used in cochlear implants (CIs) and hearing aids (HAs) to ensure their operational safety and reliability, which is crucial for advancing hearing restoration technologies.

The proposed two-phase analysis includes an acoustic phase to assess sound output safety and a parameter phase to evaluate the reliability of electrical stimulation, providing a structured approach to improve the design and testing of hearing devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation framework for research platforms to advance cochlear implant/hearing aid technology: A case study with CCi-MOBILE. Shekar, RCMC., Hansen, JHL.[2022]

The study analyzed 269 complications related to osseointegrated auditory implants (OAIs) from the MAUDE database, revealing that the majority of complications were implant-related (145 cases), but the database may not accurately represent the true incidence of complications.

The findings indicate that the MAUDE database has limitations in its design and reporting quality, suggesting a need for a better central registry to track complications associated with otologic implants and to facilitate further research into their causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Utility of the MAUDE Database for Osseointegrated Auditory Implants. Coelho, DH., Tampio, AJ.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932275/

Long-Term Outcomes Following Cochlear Implantation The purpose of this study was to evaluate the clinical and audiological outcomes in long-term cochlear implant (CI) users, focusing on hearing performance and ...

2. nature.com nature.com/articles/s43856-024-00719-0

Rehabilitation of human hearing with a totally implantable ... In this study, the authors present clinical results from a feasibility study where the TICI was implanted in six patients. Safety and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11087191/

Auditory Outcomes Following Cochlear Implantation in ... A recent meta-analysis of 119 children with UHL found that CI was associated with improved audiological and patient-reported outcomes (5).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05435612?cond=deafness&aggFilters=status:rec%20act&viewType=Table&rank=8

Evaluation of Rehabilitation Results in the Single-sided ... Evaluation of Rehabilitation Results in the Single-sided Deafness /Asymmetrical Hearing Loss With Cochlear Implantation. Conditions. Unilateral Deafness.

5. mdpi.com mdpi.com/2077-0383/13/2/400

Systematic Review of Auditory Training Outcomes in Adult ... Cochlear implantation has become the standard of care for rehabilitation of moderate to profound sensorineural hearing loss, with studies ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06086041

Predictive Study on Hearing Rehabilitation After Cochlear ... The aim of this study is to display the predictive factors of hearing rehabilitation after cochlear implant surgery in severely to profoundly ...

7. blog.medel.pro blog.medel.pro/audiology/cochlear-implantation-outcomes-in-adults-with-unilateral-deafness-speech-perception-tinnitus-sound-localization-and-quality-of-life/

Cochlear Implantation Outcomes in Adults With Unilateral ... Adults with unilateral deafness often see improvements in speech recognition, sound localization, tinnitus, and quality of life after CI.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0196070924001868

Cochlear reimplantation outcomes over 20 years Overall, CRI has been found to be safe, and some data indicate that it can lead to maintained or even improved hearing and speech performance [7,8]. However, ...