Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Audit… (NCT06305039) | Clinical Trial Compass
By InvitationNot Applicable
Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments
United States300 participantsStarted 2023-12-19
Plain-language summary
Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For Bilateral Cochlear Implant Users Arm:
Inclusion Criteria:
* two cochlear implants
* acquired their hearing loss during adulthood or late childhood (post-lingual onset)
* native English speaker
* primarily use oral language
* at least six months of cochlear implant use
* Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text
Exclusion Criteria:
* people who do not use oral language will be excluded.
* people with less than six months of device use will be excluded
* other known disability or neurological disorder
* women who are pregnant will be excluded from the CT portion of the study
* people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in either ear will be excluded
For Unilateral Cochlear Implant User with Single-Sided Deafness Arm:
Inclusion Criteria:
* one cochlear implant in one ear and a second ear with some acoustic hearing
* acquired their hearing loss during adulthood or late childhood (post-lingual onset)
* native English speaker
* primarily use oral language
* at least six months of cochlear implant use
* Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text
Exclusion Criteria:
* people who do not use oral language will be excluded.
* people with less than six months of device use will be excluded
* other known disability or neurological disorder
* women who are pregnant will be excluded from the C…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perceptual responses to sound level
Timeframe: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
2
Speech understanding in the presence of masking sounds
Timeframe: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
3
Computed-tomography scan
Timeframe: For CI users: CT scan will be collected from existing medical records with permission or taken after study enrollment. Measurements taken after study enrollment. Not collected for non-implanted listeners with acoustic hearing.
Timeframe: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.
Timeframe: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.