Clinical trial NCT06305039: Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments
Official title: Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments - Part 2
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hearing Loss
Hearing Loss, Sensorineural
Cochlear Hearing Loss
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Walter Reed National Military Medical Center
name: Vanderbilt University
First posted: 2024-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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 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 the implanted ear will be excluded
* people with an acoustic pure-tone average threshold (octave frequencies 250-4000 Hz) \> 30 dB HL in the non-implanted ear

For Non-Implanted Listeners with Acoustic Hearing Arm:

Inclusion Criteria:

* audiometrically normal hearing or near-normal hearing, or mild/moderate hearing loss
* Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Exclusion Criteria:

* severe hearing loss
* other known disability or neurological disorder

Primary outcomes:
measure: 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.
measure: 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.
measure: 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.
measure: Electrode impedance (transelectrode impedance matrix)
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.
measure: Electrically evoked compound action potentials (ECAPs)
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.
Secondary outcomes:
measure: Sound Localization
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.
measure: Perceptual Fusion
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.
measure: Spectrotemporal ripple sensitivity
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.
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: College Park
country: United States
facility: University of Maryland, College Park
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Matthew J. Goupell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed National Military Medical Center; University of Maryland, College Park
name: Joshua G. Bernstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: