Auditory Perception; AbnormalNCT06516575
Listening Effort in Cochlear Implant Users
A study testing sentence manipulations in people with Auditory Perception; Abnormal and Hearing Loss, Sensorineural, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Perception; Abnormal, Hearing Loss, Sensorineural, Hearing Loss
- What is being tested?
- sentence manipulations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- unable to fix gaze position
- eye disease preventing typical changes in pupil dilation
- lack of perceptual and productive fluency in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katherine Teece, AuD contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the detailed description
General methods:
Speech recognition testing: The main experimental task is listening to speech in the free field in a sound-attenuated booth. Traditional speech recognition consists of hearing and repeating sentences, and these studies will vary on that general theme with modifications to suit the specific aims of the project. For example, some stimuli are repeated twice before verbal response, and some are questions and answers rather than declarative sentences. The investigators have developed the stimuli specifically for each experiment, always avoiding emotionally evocative stimuli since they can have large effects on pupil dilation.
Intelligibility: The investigators will track percent-correct scores for whole sentences and words within each sentence. The investigators also track the position of mistakes during the sentence (e.g. first word, last word), and whether the participant's response could feasibly be a sensible utterance, or whether it lacks any coherent meaning, because this factor has such a large effect on listening effort.
The investigators will test normal-hearing (NH, or TH Typical Hearing) listeners' perception of both regular speech and vocoded speech, allowing us to separately examine the influence of signal degradation separately from the chronic experience of hearing difficulty.
Pupillometry: During speech recognition tests, 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, based on numerous published studies.
Microsaccade tracking: small eye movements will be tracked concurrently with pupil size (described above) as an additional measurement of attentional effort.
Blink tracking: blinks will be tracked concurrently with pupil dilation and microsaccades (described above).
Experiment 1A: The investigators will test the ability to prepare extra effort in a study where the listener knows in advance whether an upcoming stimulus will be easier or harder to understand. Each trial begins with a cue of "easy" or "hard" displayed in text on the screen. Following a four-second delay to let the pupils return to baseline, the sentence is played. Pupil dilation is tracked throughout the entire trial, with the crucial differences being examined between the text signal and the onset of the speech, reflecting the listener's momentary preparation of extra effort. Importantly, the easy and hard trials are randomly intermixed rather than blocked, so that the elicited effort specifically reflects momentary preparation rather than a long-term disposition.
Experiment 2A: This task simulates a misperception of a word during a sentence, with an opportunity to hear a repetition of the sentence to clarify that word. In each trial, a sentence is played twice. In the first presentation, the sentence is either fully intact (normal), or has a single word replaced by noise. The sentences are constructed so that the word is essential to the meaning of the sentence, but cannot be recovered by context. In the second presentation, the sentence is always fully intact, enabling restoration of the missing word.
Experiment 2B: This task simulates a situation where a listener aims effort at specific points in time based on their listening needs. Participants will complete a standard sentence repetition task, but with stimuli where key information is placed at earlier or later parts of the trial, and which have different levels of importance to the task.
Experiment 3A: Judging answers to questions. In each trial, the participant hears a question (Q) and an answer (A) spoken by a different talker, as for a conversational dyad. The participant is prompted to respond with "yes" (the answer was correct) or "no" (the answer was not correct).The answer can be either correct, incorrect, or completely unexpected (nonsense), randomly varying trial to trial. The nonsense answers invite a moment of second-guessing the perception since they are so unexpected.
Experiment 3B: This is similar to experiment 3A, but instead of completely unexpected answers, the listener will hear an answer that is related to the question, inviting a reassessment of whether the question was heard correctly. For example, "What color is a basketball? Round" would invite the listener to momentarily doubt whether the question was understood correctly.
Experiment 3C: This experiment requires the listener to use prosody to determine whether a talker is continuing to speak or if they are done speaking. Effort devoted to listening will be tracked using a combination of reaction time and eye-tracking measures such as pupillometry.
Experiment 3D: The reliance on post-sentence effort will be examined in a behavioral study where listeners hear a continuous stream of sentences and can manually adjust the rate of speech (manipulated using the pitch-synchronous overlap-add PSOLA algorithm in Praat) until arriving at a comfortable pace.
- Being tested
- sentence manipulations
- Keywords
- cochlear implants, listening effort
- Medical subject headings
- Antisocial Personality Disorder, Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentence manipulationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: sentence manipulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Listening effort
Listening effort is inferred by measuring changes in pupil dilation linked to stimulus landmarks, as well as changes in microsaccade rate and blinks
Measured: 60 - 90 minute testing session
Speech intelligibility
Intelligibility is scored by tallying the accuracy of spoken responses to auditory speech stimuli
Measured: 60 - 90 minute testing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Sep 2023
- Primary completion28 Apr 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Perception; AbnormalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516575
- Sponsor's protocol ID
- R01DC017114
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: de-identified data will be posted on the Open Science Framework website
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Listening Effort in Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT06516575
- Acronym / sponsor ID
- R01DC017114
- Keywords
- cochlear implants, listening effort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
General methods:
Speech recognition testing: The main experimental task is listening to speech in the free field in a sound-attenuated booth. Traditional speech recognition consists of hearing and repeating sentences, and these studies will vary on that general theme with modifications to suit the specific aims of the project. For example, some stimuli are repeated twice before verbal response, and some are questions and answers rather than declarative sentences. The investigators have developed the stimuli specifically for each experiment, always avoiding emotionally evocative stimuli since they can have large effects on pupil dilation.
Intelligibility: The investigators will track percent-correct scores for whole sentences and words within each sentence. The investigators also track the position of mistakes during the sentence (e.g. first word, last word), and whether the participant's response could feasibly be a sensible utterance, or whether it lacks any coherent meaning, because this factor has such a large effect on listening effort.
The investigators will test normal-hearing (NH, or TH Typical Hearing) listeners' perception of both regular speech and vocoded speech, allowing us to separately examine the influence of signal degradation separately from the chronic experience of hearing difficulty.
Pupillometry: During speech recognition tests, 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, based on numerous published studies.
Microsaccade tracking: small eye movements will be tracked concurrently with pupil size (described above) as an additional measurement of attentional effort.
Blink tracking: blinks will be tracked concurrently with pupil dilation and microsaccades (described above).
Experiment 1A: The investigators will test the ability to prepare extra effort in a study where the listener knows in advance whether an upcoming stimulus will be easier or harder to understand. Each trial begins with a cue of "easy" or "hard" displayed in text on the screen. Following a four-second delay to let the pupils return to baseline, the sentence is played. Pupil dilation is tracked throughout the entire trial, with the crucial differences being examined between the text signal and the onset of the speech, reflecting the listener's momentary preparation of extra effort. Importantly, the easy and hard trials are randomly intermixed rather than blocked, so that the elicited effort specifically reflects momentary preparation rather than a long-term disposition.
Experiment 2A: This task simulates a misperception of a word during a sentence, with an opportunity to hear a repetition of the sentence to clarify that word. In each trial, a sentence is played twice. In the first presentation, the sentence is either fully intact (normal), or has a single word replaced by noise. The sentences are constructed so that the word is essential to the meaning of the sentence, but cannot be recovered by context. In the second presentation, the sentence is always fully intact, enabling restoration of the missing word.
Experiment 2B: This task simulates a situation where a listener aims effort at specific points in time based on their listening needs. Participants will complete a standard sentence repetition task, but with stimuli where key information is placed at earlier or later parts of the trial, and which have different levels of importance to the task.
Experiment 3A: Judging answers to questions. In each trial, the participant hears a question (Q) and an answer (A) spoken by a different talker, as for a conversational dyad. The participant is prompted to respond with "yes" (the answer was correct) or "no" (the answer was not correct).The answer can be either correct, incorrect, or completely unexpected (nonsense), randomly varying trial to trial. The nonsense answers invite a moment of second-guessing the perception since they are so unexpected.
Experiment 3B: This is similar to experiment 3A, but instead of completely unexpected answers, the listener will hear an answer that is related to the question, inviting a reassessment of whether the question was heard correctly. For example, "What color is a basketball? Round" would invite the listener to momentarily doubt whether the question was understood correctly.
Experiment 3C: This experiment requires the listener to use prosody to determine whether a talker is continuing to speak or if they are done speaking. Effort devoted to listening will be tracked using a combination of reaction time and eye-tracking measures such as pupillometry.
Experiment 3D: The reliance on post-sentence effort will be examined in a behavioral study where listeners hear a continuous stream of sentences and can manually adjust the rate of speech (manipulated using the pitch-synchronous overlap-add PSOLA algorithm in Praat) until arriving at a comfortable pace.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant participants | Experimental | Behavioral: sentence manipulationsParticipants 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. |
| Typical-hearing controls | Active comparator | Behavioral: sentence manipulationsTypical-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 may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- unable to fix gaze position
- eye disease preventing typical changes in pupil dilation
- lack of perceptual and productive fluency in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sentence manipulationsAuditory 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. | Behavioural | Cochlear implant participants, Typical-hearing controls |
Primary outcome
Listening effort
Time frame: 60 - 90 minute testing session
Listening effort is inferred by measuring changes in pupil dilation linked to stimulus landmarks, as well as changes in microsaccade rate and blinks
Speech intelligibility
Time frame: 60 - 90 minute testing session
Intelligibility is scored by tallying the accuracy of spoken responses to auditory speech stimuli
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. de-identified data will be posted on the Open Science Framework website
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Teece, AuD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sentence manipulations in people with Auditory Perception; Abnormal and Hearing Loss, Sensorineural, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Winn, PhD, AuD (612-624-4733, mwinn@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Listening effort (time frame: 60 - 90 minute testing session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.