Listening Effort in Cochlear Implant Users

NCT06516575 | Recruiting

• 1 other identifier: R01DC017114
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

People with hearing loss experience extra effort when listening, which can lead to severe psychological barriers to communication and social participation. Listening effort can lead to fatigue, mental strain, burnout, medical sick leave, and the need for increased time to recover from regular daily activities. This proposal aims to understand effort changes on a moment-to-moment basis during listening, how long the effort lasts, and how the planning and execution of effort is impacted by the experience of using a cochlear implant.

Conditions

Auditory Perception; Abnormal; Hearing Loss, Sensorineural; Hearing Loss

Keywords

cochlear implants; listening effort

Outcome Measures

Primary Outcomes (2)

• Listening effort

  Listening effort is inferred by measuring changes in pupil dilation linked to stimulus landmarks

  60 - 90 minute testing session

• Speech intelligibility

  Intelligibility is scored by tallying the accuracy of spoken responses to auditory speech stimuli

  60 - 90 minute testing session

Study Arms (2)

Cochlear implant participants

EXPERIMENTAL

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.

Behavioral: sentence manipulations

Typical-hearing controls

ACTIVE COMPARATOR

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.

Behavioral: sentence manipulations

Interventions

sentence manipulations BEHAVIORAL

Auditory stimuli (sentences) are manipulated to have key words masked by noise, or to have prosody (pitch contour) manipulated to be consistent or inconsistent with a specific inferred meaning. Participants repeat the sentences while a camera tracks changes in their eye movements and changes in pupil dilation.

Cochlear implant participants; Typical-hearing controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for this study, a participant must:
• Be an adult between the age of 18 to 75 years
• Have had normal hearing and speech/language development as a young child
• For younger NH listeners: have normal audiometric thresholds below 25 dB HL at frequencies between 250 and 8000 Hz
• for cochlear implant listeners: at least 6 months experience with a cochlear implant
• For older (55+ years) age-matched listeners with no cochlear implant: normal audiometric thresholds below 25 dB HL at frequencies between 250 and 2000 Hz and thresholds below 35 dB HL (hearing level) between 4000 and 8000 Hz
• For cochlear implant listeners: be able to recognize spoken words in English at a rate of at least 50%
• Be a competent speaker of north American English
• Lack language-learning or other cognitive disabilities
• Lack of auditory neuropathy spectrum disorder

You may not qualify if:

• unable to fix gaze position
• eye disease preventing typical changes in pupil dilation
• lack of perceptual and productive fluency in English

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Antisocial Personality Disorder; Hearing Loss, Sensorineural; Hearing Loss

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Matthew Winn, PhD, AuD

CONTACT

612-624-4733; mwinn@umn.edu

Katherine Teece, AuD

CONTACT

henn0158@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)