Hearing LossNCT06305039
Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments
A study testing Diagnostic tests of cochlear implant or acoustic hearing function and Targeted aural rehabilitation of the poorer performing ear in people with Hearing Loss and Hearing Loss, Sensorineural, run by University of Maryland, College Park at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss, Hearing Loss, Sensorineural, Cochlear Hearing Loss
- What is being tested?
- Diagnostic tests of cochlear implant or acoustic hearing function and Targeted aural rehabilitation of the poorer performing ear
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2023to 31 May 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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:
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- 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:
- severe hearing loss
- other known disability or neurological disorder
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Maryland, College Park
College Park, Maryland, 20742
About this study
Official title: Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments - Part 2
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.
- Being tested
- Diagnostic tests of cochlear implant or acoustic hearing function, Targeted aural rehabilitation of the poorer performing ear
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic tests of cochlear implant or acoustic hearing functionDiagnostic test
Because the cochlear implant participants in the study will use cochlear implant devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of cochlear implant or acoustic hearing function. This will include perceptual tests of sound localization, speech understanding in noise, binaural fusion, and loudness comparisons.
Targeted aural rehabilitation of the poorer performing earBehavioural
Subjects will undergo listening practice on a tablet computer over headphones at home. For the test group, the aural rehabilitation will be targeted at the poorer ear. For the comparison control group, a sham aural rehabilitation will present speech to both ears.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Cochlear Implant Users | Experimental | Not described Receives: Diagnostic Test: Diagnostic tests of cochlear implant or acoustic hearing function; Behavioral: Targeted aural rehabilitation of the poorer performing ear |
| Unilateral Cochlear Implant Users with Single-Sided Deafness | Experimental | Not described Receives: Diagnostic Test: Diagnostic tests of cochlear implant or acoustic hearing function; Behavioral: Targeted aural rehabilitation of the poorer performing ear |
| Non-Implanted Listeners with Acoustic Hearing | Other | Not described Receives: Diagnostic Test: Diagnostic tests of cochlear implant or acoustic hearing function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptual responses to sound level
Interaural loudness mismatch is defined as the difference between the levels required to balance interaural loudness for sequential stimulation and the levels required to perceptually center a sound image in space for simultaneous stimulation. Participants will respond through pressing virtual buttons on a computer screen. Depending on the condition tested, the sounds will be delivered to one or both ears.
Measured: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Speech understanding in the presence of masking sounds
Speech understanding will be assessed as the percentage of correctly identified keywords.
Subjects will respond through oral report (where the responses will be scored by the experimenter) or through pressing virtual buttons on a computer screen. The speech sounds will be delivered to one or both ears in the presence of different types of masking sounds. In some cases, signal processing techniques will be used to distort the speech signals to simulate asymmetric hearing abilities.
Measured: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Computed-tomography scan
A computed tomography temporal bone scan will be used to image the cochlear structures and cochlear implant electrode array located within. This scan will use a standard clinical scanner, with software updated to extend the Hounsfield range to reduce artifact from the metal contacts of the electrode array. This procedure uses radiographic processes, and therefore presents the subject with a safe but nonzero amount of radiation. The CT scan will be analyzed to provide measurements of each array's insertion depth within the cochlea (in degrees and mm), the distance to the cochlear modiolus (mm), and cochlear scalar location.
Measured: 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.
Electrode impedance (transelectrode impedance matrix)
This standard clinical measurement will apply a current to one electrode, and measure the resulting induced voltage at each of the other electrodes in the array, one at a time. This process uses low-level electrical stimulation only intended to measure the impedance of the intervening tissues and fluids of the cochlea, and is rarely even perceived by the subject.
Measured: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.
Electrically evoked compound action potentials (ECAPs)
Electrically evoked compound action potentials (ECAPs) will be measured using clinically-available software to track the growth in auditory nerve response (observed ~0.2-0.8 ms post-stimulus onset) as input level is varied from threshold to the maximal level at which the signal is comfortably loud. The slope of input-output function will be measured ( in microvolts/current unit) for each electrode along the electrode array of each cochlear implant study participant.
Measured: 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 (3)
Sound Localization
Participants' ability to localize a virtual sound source in space will be measured. Subjects will be presented with a broadband sound, with signal processing applied (temporal delays and spectral shaping) to simulate a spatial location of the sound source. Subjects will respond through pressing virtual buttons on a computer screen.
Measured: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Perceptual Fusion
Participants' ability to perceptually fuse sounds presented to the ears will be measured. Subjects will be presented with a broadband sound, and will respond through pressing virtual buttons on the computer screen as to (1) how many sounds were heard and where they were perceived inside the head, or (2) which of two mixtures presented contained a larger number of voices.
Measured: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Spectrotemporal ripple sensitivity
This test will be used to evaluate asymmetry in a perceptual measure thought to reflect the peripheral contribution to intersubject variability in speech understanding. This will allow for a baseline from which to ask if the electrophysiological measures provide additional predictive power regarding contralateral disruption beyond the perceptual measures of peripheral asymmetry.
Measured: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start19 Dec 2023
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Walter Reed National Military Medical Center, Vanderbilt University
- Responsible party
- Principal investigator, Matthew Goupell, University of Maryland, College Park
- Investigators
- Matthew J. Goupell, PhD, Principal investigator, University of Maryland, College ParkJoshua G. Bernstein, PhD, Principal investigator, Walter Reed National Military Medical Center; University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305039
- Sponsor's protocol ID
- 2089705
- Other IDs
- 1R01DC020506-01A1
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. De-identified data relevant to the project will be disseminated to researchers on and off-campus by request and review of the PI. After publication, research products from this project will be archived at the Digital Repository at the University of Maryland(DRUM). DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments - Part 2
- ClinicalTrials.gov ID
- NCT06305039
- Acronym / sponsor ID
- 2089705
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Walter Reed National Military Medical Center, Vanderbilt University
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 12 Mar 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral Cochlear Implant Users | Experimental | Diagnostic Test: Diagnostic tests of cochlear implant or acoustic hearing function, Behavioral: Targeted aural rehabilitation of the poorer performing ear |
| Unilateral Cochlear Implant Users with Single-Sided Deafness | Experimental | Diagnostic Test: Diagnostic tests of cochlear implant or acoustic hearing function, Behavioral: Targeted aural rehabilitation of the poorer performing ear |
| Non-Implanted Listeners with Acoustic Hearing | Other | Diagnostic Test: Diagnostic tests of cochlear implant or acoustic hearing function |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Diagnostic tests of cochlear implant or acoustic hearing functionBecause the cochlear implant participants in the study will use cochlear implant devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of cochlear implant or acoustic hearing function. This will include perceptual tests of sound localization, speech understanding in noise, binaural fusion, and loudness comparisons. | Diagnostic test | Bilateral Cochlear Implant Users, Non-Implanted Listeners with Acoustic Hearing, Unilateral Cochlear Implant Users with Single-Sided Deafness |
| Targeted aural rehabilitation of the poorer performing earSubjects will undergo listening practice on a tablet computer over headphones at home. For the test group, the aural rehabilitation will be targeted at the poorer ear. For the comparison control group, a sham aural rehabilitation will present speech to both ears. | Behavioural | Bilateral Cochlear Implant Users, Unilateral Cochlear Implant Users with Single-Sided Deafness |
Primary outcome
Perceptual responses to sound level
Time frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Interaural loudness mismatch is defined as the difference between the levels required to balance interaural loudness for sequential stimulation and the levels required to perceptually center a sound image in space for simultaneous stimulation. Participants will respond through pressing virtual buttons on a computer screen. Depending on the condition tested, the sounds will be delivered to one or both ears.
Speech understanding in the presence of masking sounds
Time frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Speech understanding will be assessed as the percentage of correctly identified keywords. Subjects will respond through oral report (where the responses will be scored by the experimenter) or through pressing virtual buttons on a computer screen. The speech sounds will be delivered to one or both ears in the presence of different types of masking sounds. In some cases, signal processing techniques will be used to distort the speech signals to simulate asymmetric hearing abilities.
Computed-tomography scan
Time frame: 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.
A computed tomography temporal bone scan will be used to image the cochlear structures and cochlear implant electrode array located within. This scan will use a standard clinical scanner, with software updated to extend the Hounsfield range to reduce artifact from the metal contacts of the electrode array. This procedure uses radiographic processes, and therefore presents the subject with a safe but nonzero amount of radiation. The CT scan will be analyzed to provide measurements of each array's insertion depth within the cochlea (in degrees and mm), the distance to the cochlear modiolus (mm), and cochlear scalar location.
Electrode impedance (transelectrode impedance matrix)
Time frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.
This standard clinical measurement will apply a current to one electrode, and measure the resulting induced voltage at each of the other electrodes in the array, one at a time. This process uses low-level electrical stimulation only intended to measure the impedance of the intervening tissues and fluids of the cochlea, and is rarely even perceived by the subject.
Electrically evoked compound action potentials (ECAPs)
Time frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.
Electrically evoked compound action potentials (ECAPs) will be measured using clinically-available software to track the growth in auditory nerve response (observed ~0.2-0.8 ms post-stimulus onset) as input level is varied from threshold to the maximal level at which the signal is comfortably loud. The slope of input-output function will be measured ( in microvolts/current unit) for each electrode along the electrode array of each cochlear implant study participant.
3 secondary outcomes
Sound Localization
Time frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Perceptual Fusion
Time frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
Spectrotemporal ripple sensitivity
Time frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
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 28 Mar 2025.
- Individual participant dataSharing planned: Yes. De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. De-identified data relevant to the project will be disseminated to researchers on and off-campus by request and review of the PI. After publication, research products from this project will be archived at the Digital Repository at the University of Maryland(DRUM). DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse.
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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.
Matthew J. Goupell, PhD principal investigator
University of Maryland, College Park
Joshua G. Bernstein, PhD principal investigator
Walter Reed National Military Medical Center; University of Maryland, College Park
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic tests of cochlear implant or acoustic hearing function and Targeted aural rehabilitation of the poorer performing ear in people with Hearing Loss and Hearing Loss, Sensorineural, run by University of Maryland, College Park at 2 sites 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 14 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptual responses to sound level (time frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.). The study lists 5 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 28 Mar 2025.