Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT06516575

Conditions

Auditory Perception; Abnormal

Hearing Loss, Sensorineural

Hearing Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

sentence manipulations

Study Details

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

Study ID

NCT06516575

Start date

Sep 1, 2023

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Apr 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cochlear implant participants

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.

active comparator: Typical-hearing controls

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.

Interventions

sentence manipulations

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.

Primary outcome measure

  • Listening effort [ Time Frame: 60 - 90 minute testing session ]
  • Speech intelligibility [ Time Frame: 60 - 90 minute testing session ]

Central Contacts and Locations

Central contacts

Matthew Winn, PhD, AuD

612-624-4733mwinn@umn.edu

Katherine Teece, AuD

henn0158@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • cochlear implants
  • listening effort

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-08-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.