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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 between 4000 and 8000 Hz
For cochlear implant listeners: be able to recognize spoken words in English at a rate of at least 50%
Must not have
Unable to fix gaze position
Eye disease preventing typical changes in pupil dilation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 - 90 minute testing session
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand how people with hearing loss experience extra effort when listening and how it affects their daily activities and social interactions. The researchers want to see how long this effort lasts and how using a
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical interventions related to sentence manipulation, there are no direct medical side effects. However, participants may experience mental fatigue or stress during the listening tasks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 or older with normal hearing for low and mid frequencies, and slightly reduced for high frequencies.
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I can understand spoken English words at least half the time with my cochlear implant.
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I do not have a hearing disorder known as auditory neuropathy.
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I am between 18 and 75 years old.
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My hearing is normal, with no loss below 25 dB from low to high tones.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot keep my eyes fixed on one spot.
Select...
I have an eye condition that affects how my pupils change size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 - 90 minute testing session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 - 90 minute testing session
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Listening effort
Speech intelligibility
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cochlear implant participantsExperimental Treatment1 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 controlsActive Control1 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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,193 Total Patients Enrolled
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