Bilateral Cochlear ImplantsNCT07765186
Spatial Cues, Task Demands, and Auditory Selective Attention
A study testing Existing bilateral cochlear implants in people with Bilateral Cochlear Implants and Hearing Loss, Bilateral, run by University of South Florida at 1 site in United States.
Trial summary
Understanding speech in restaurants and other noisy environments is the most common complaint from the more than 60 million Americans with hearing impairment. Succeeding in such environments requires a listener to first segregate sound sources and then selectively attend to the source of interest. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Cochlear Implants, Hearing Loss, Bilateral, Healthy
- What is being tested?
- Existing bilateral cochlear implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2025to Jul 2030
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with normal hearing, confirmed by audiometric assessment (thresholds within 20 dB HL of normal through 8 kHz), OR adults with bilateral cochlear implants who have used their implants for at least one year
- Native speakers of American English
- Normal or corrected-to-normal vision
Who cannot join
- Known neurological disorders
- For fMRI sessions (normal-hearing participants only): contraindications to MRI scanning; cochlear implant users do not complete MRI sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida, PCD Building, Room 3008A
Tampa, Florida, 33620
Christopher A Brown, PhD, 412-670-2772, cb43@usf.edu
About this study
Official title: How Spatial Cues Support Communication: Interactions Between Auditory Spatial Features and Task Demands Across Cortical Networks
Understanding speech in restaurants and other noisy environments is the most common complaint from the more than 60 million Americans with hearing impairment. Succeeding in such environments requires a listener to first segregate sound sources and then selectively attend to the source of interest. This study examines how individual auditory spatial cues (interaural time differences and interaural level differences) support spatial selective attention, the cortical processes that underlie this ability, and how these processes are modulated by task demands. Participants with normal hearing and participants who use bilateral cochlear implants will perform listening tasks while brain and physiological responses are recorded (electroencephalography, functional near-infrared spectroscopy, pupillometry, and, for normal-hearing participants only, functional magnetic resonance imaging). The findings will provide new insights into the mechanisms of spatial selective attention and help guide clinical solutions for cochlear implant users, individuals with hearing impairment more generally, and older normal-hearing adults who have difficulty understanding speech in noisy environments.
Read the detailed description
This study will examine the contributions of spatial cues (interaural level differences and interaural time differences) and task demands on spatial selective attention. Aim 1 will simultaneously collect functional near infrared spectroscopy (fNIRS), electroencephalography (EEG), pupillometry, and behavioral data in normal-hearing (NH) participants, while they perform tasks designed to probe various aspects of spatial selective attention. We will make every effort to include as many Aim 1 participants in Aim 2 as possible. Aim 2 will record functional magnetic resonance imaging (fMRI) during the same tasks. Aim 3 will essentially replicate Aim 1 in bilateral CI users. We will not record fMRI with CI users due to safety concerns.
Paradigm 1. The paradigm will require listeners to hold information in working memory. We will measure effects of task demands and auditory spatial cues on cognitive and sensory responses to a single stream of stimuli. Stimuli will be a set of recorded "crash" sound effects with a broadband frequency profile, ideal for spatialization (important because a main goal of ours is to compare measures when spatialization is achieved with either interaural time differences (ITDs), which dominate spatial perception in the low-frequency region, or interaural level differences (ILDs), which dominate in the high-frequency region). Taxing working memory is an important component to the paradigm because it will allow us to influence listening effort, a critical factor in our hypotheses, and because it will ensure engagement of prefrontal cortex, which we hypothesize drives lateralization of activity in auditory cortex.
Paradigm 2. The paradigm asks listeners to attend to either the Location or the Pitch of a single speech token, hold that value in memory while a diffuse noise masker is presented, and compare the remembered location or pitch to a subsequent probe token. The noise masker will ensure that listeners cannot rely on echoic memory. We will examine the effects of task demands and spatial cues on auditory cortex spatial selectivity. As with Paradigm 1 (and for the same reasons), the choice to force listeners to use working memory to perform the task was deliberate. Here, the main goal is to force listeners to have to map a perceived location to exogenous space, which is the only way to hold a location in memory. This should allow us to observe auditory cortical tuning with much more precision.
Paradigm 3. This paradigm will present listeners with an ongoing, isochronous stream of words, which can be spoken by either a male or a female, and which will be spatialized to come from either the left or right. There are two tasks. The first is to attend to a given talker (male or female), and ignore location, and the second is to attend to a given location and ignore talker. On each trial, subjects must count the number of occurrences of a particular word that match the feature that they are asked to attend. The goal here is to force participants to use either space or to use another cue (voice pitch) to perform the task.
Neuroimaging Approach 1. We will use EEG to record event-related potentials, which will allow us to observe changes in encoding and lateralization of sounds, which should increase as spatial cue quality increases. fNIRS will allow us to measure prefrontal cortical activity during task engagement, which has been linked to cognitive effort. Pupillometry will provide a more traditional, well-defined measure of overall effort. Behavior will provide an indication of the summative contributions of each factor.
Neuroimaging Approach 2. We will use fMRI to look at stimulus-induced lateralization and spatial receptive fields in auditory cortex. We will also look for particular activity in prefrontal cortex indicating recruitment of visually-biased regions, associated with spatial processing. These regions have particular importance to our hypotheses, because they are only engaged when space is required to perform an auditory task.
We propose nine experiments. Six experiments will test NH listeners, and will each leverage one of the three paradigms and one of the two neuroimaging approaches. The three additional experiments will test bilateral CI users, and we will use only neuroimaging approach 1 (fNIRS/EEG/Pupillometry), due to safety concerns regarding their medical devices and the MRI scanner.
- Being tested
- Existing bilateral cochlear implants, Normal Hearing Control
- Keywords
- spatial hearing, auditory selective attention, interaural level difference, interaural time difference, cochlear implant, EEG, fNIRS, fMRI, pupillometry, speech in noise
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Existing bilateral cochlear implantsDevice
Participants in this arm are recruited from a population who have existing bilateral cochlear implants. The implants are the participants' own clinical devices, used as clinically programmed; no investigational device or modification is provided by the study. Auditory attention tasks are presented with manipulated spatial cues (interaural time differences, interaural level differences, or HRTFs).
Normal Hearing ControlOther
Control group recruited from the normal hearing population. Participants perform the same auditory attention tasks with manipulated spatial cues (interaural time differences, interaural level differences, or HRTFs) under EEG/fNIRS/pupillometry and fMRI.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Cochlear Implant Users | Other | Adults with existing bilateral cochlear implants (implanted and using their devices for at least one year). Participants complete the discrimination and selective-attention auditory paradigms with manipulated spatial cues while combined EEG, fNIRS, and pupillometry are recorded. No fMRI is collected in this arm due to device safety concerns. Receives: Device: Existing bilateral cochlear implants |
| Normal Hearing Controls | Other | Adults with audiometrically confirmed normal hearing (thresholds within 20 dB HL of normal through 8 kHz). Participants complete three auditory attention paradigms (working memory, discrimination, selective attention) with manipulated spatial cues, under combined EEG, fNIRS, and pupillometry sessions and fMRI sessions. Receives: Other: Normal Hearing Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG
EEG data acquired using 32 Ag-Ag/Cl electrodes embedded in an elastic cap (Brain Products), impedances below 20 kOhms, locations per the extended 10-20 system, recorded at 5 kHz from 0.1-100 Hz. Event-related potentials (including attentional modulation of the N1) and parietal alpha lateralization are compared across spatial-cue and task-demand conditions.
Measured: 2 hours
NIRS
Functional near-infrared spectroscopy collected with a montage targeting bilateral superior temporal gyrus (STG) and bilateral prefrontal cortex, using a NIRSport 2 8x8 channel system (NIRx) with long- and short-distance channel probes; 3D structural head scanning registers probe placement. Optical signals recorded at 10 Hz with an average source-detector distance of 35 mm. Oxygenated and deoxygenated hemoglobin responses are compared across conditions.
Measured: 2 hours
Pupillometry
Pupil dilation from both eyes recorded with the EyeLink 1000 at a sampling rate of 1000 Hz, normalized to each participant pupillary dynamic range, as an index of listening effort across conditions.
Measured: 2 hours
MRI
Data acquired on a 3 Tesla Siemens Prisma MRI scanner (64-channel head coil). High-resolution (0.8 mm iso) T1-weighted multi-echo MP-RAGE and T2-weighted SPACE images collected for cortical reconstruction (FreeSurfer); functional MRI measures stimulus-induced lateralization and spatial receptive fields in auditory cortex. Normal-hearing arm only.
Measured: 2 hours
Discrimination (DISCR)
Behavioral discrimination performance for spatialized sounds. HRTFs span +/- 90 degrees, broadband ILDs span +/- 20 dB, and broadband ITDs span +/- 800 microseconds; values chosen to roughly equate perceived lateral range across cues.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start22 Oct 2025
- Primary completionApr 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Cochlear ImplantsStudies 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
- Model description
- Case-control-style design with two participant populations (normal-hearing adults and adult bilateral cochlear implant users). All experimental manipulations (spatial cue type, task demands) are within-subject.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Carnegie Mellon University
- Responsible party
- Principal investigator, Christopher Brown, University of South Florida
- Investigators
- Christopher A Brown, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765186
- Sponsor's protocol ID
- STUDY008767
- Other IDs
- R01DC022699
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary measures (behavioral, EEG, fNIRS, pupillometry, and MRI) will be publicly shared in BIDS-compliant format, per the NIH Data Management and Sharing Plan for this award. Smaller datasets (demographics, behavioral scores) will be shared as text/CSV files via GitHub and permanently archived on Zenodo; larger neuroimaging datasets will be shared on Zenodo directly, with permanent DOIs. Custom acquisition and analysis software will also be shared via GitHub and archived on Zenodo.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Spatial Cues Support Communication: Interactions Between Auditory Spatial Features and Task Demands Across Cortical Networks
- ClinicalTrials.gov ID
- NCT07765186
- Acronym / sponsor ID
- STUDY008767
- Keywords
- spatial hearing, auditory selective attention, interaural level difference, interaural time difference, cochlear implant, EEG, fNIRS, fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Carnegie Mellon University
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 14 Aug 2026 (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.
Understanding speech in restaurants and other noisy environments is the most common complaint from the more than 60 million Americans with hearing impairment. Succeeding in such environments requires a listener to first segregate sound sources and then selectively attend to the source of interest. This study examines how individual auditory spatial cues (interaural time differences and interaural level differences) support spatial selective attention, the cortical processes that underlie this ability, and how these processes are modulated by task demands. Participants with normal hearing and participants who use bilateral cochlear implants will perform listening tasks while brain and physiological responses are recorded (electroencephalography, functional near-infrared spectroscopy, pupillometry, and, for normal-hearing participants only, functional magnetic resonance imaging). The findings will provide new insights into the mechanisms of spatial selective attention and help guide clinical solutions for cochlear implant users, individuals with hearing impairment more generally, and older normal-hearing adults who have difficulty understanding speech in noisy environments.
Detailed description
This study will examine the contributions of spatial cues (interaural level differences and interaural time differences) and task demands on spatial selective attention. Aim 1 will simultaneously collect functional near infrared spectroscopy (fNIRS), electroencephalography (EEG), pupillometry, and behavioral data in normal-hearing (NH) participants, while they perform tasks designed to probe various aspects of spatial selective attention. We will make every effort to include as many Aim 1 participants in Aim 2 as possible. Aim 2 will record functional magnetic resonance imaging (fMRI) during the same tasks. Aim 3 will essentially replicate Aim 1 in bilateral CI users. We will not record fMRI with CI users due to safety concerns.
Paradigm 1. The paradigm will require listeners to hold information in working memory. We will measure effects of task demands and auditory spatial cues on cognitive and sensory responses to a single stream of stimuli. Stimuli will be a set of recorded "crash" sound effects with a broadband frequency profile, ideal for spatialization (important because a main goal of ours is to compare measures when spatialization is achieved with either interaural time differences (ITDs), which dominate spatial perception in the low-frequency region, or interaural level differences (ILDs), which dominate in the high-frequency region). Taxing working memory is an important component to the paradigm because it will allow us to influence listening effort, a critical factor in our hypotheses, and because it will ensure engagement of prefrontal cortex, which we hypothesize drives lateralization of activity in auditory cortex.
Paradigm 2. The paradigm asks listeners to attend to either the Location or the Pitch of a single speech token, hold that value in memory while a diffuse noise masker is presented, and compare the remembered location or pitch to a subsequent probe token. The noise masker will ensure that listeners cannot rely on echoic memory. We will examine the effects of task demands and spatial cues on auditory cortex spatial selectivity. As with Paradigm 1 (and for the same reasons), the choice to force listeners to use working memory to perform the task was deliberate. Here, the main goal is to force listeners to have to map a perceived location to exogenous space, which is the only way to hold a location in memory. This should allow us to observe auditory cortical tuning with much more precision.
Paradigm 3. This paradigm will present listeners with an ongoing, isochronous stream of words, which can be spoken by either a male or a female, and which will be spatialized to come from either the left or right. There are two tasks. The first is to attend to a given talker (male or female), and ignore location, and the second is to attend to a given location and ignore talker. On each trial, subjects must count the number of occurrences of a particular word that match the feature that they are asked to attend. The goal here is to force participants to use either space or to use another cue (voice pitch) to perform the task.
Neuroimaging Approach 1. We will use EEG to record event-related potentials, which will allow us to observe changes in encoding and lateralization of sounds, which should increase as spatial cue quality increases. fNIRS will allow us to measure prefrontal cortical activity during task engagement, which has been linked to cognitive effort. Pupillometry will provide a more traditional, well-defined measure of overall effort. Behavior will provide an indication of the summative contributions of each factor.
Neuroimaging Approach 2. We will use fMRI to look at stimulus-induced lateralization and spatial receptive fields in auditory cortex. We will also look for particular activity in prefrontal cortex indicating recruitment of visually-biased regions, associated with spatial processing. These regions have particular importance to our hypotheses, because they are only engaged when space is required to perform an auditory task.
We propose nine experiments. Six experiments will test NH listeners, and will each leverage one of the three paradigms and one of the two neuroimaging approaches. The three additional experiments will test bilateral CI users, and we will use only neuroimaging approach 1 (fNIRS/EEG/Pupillometry), due to safety concerns regarding their medical devices and the MRI scanner.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-control-style design with two participant populations (normal-hearing adults and adult bilateral cochlear implant users). All experimental manipulations (spatial cue type, task demands) are within-subject.
| Arm | Type | Receives |
|---|---|---|
| Bilateral Cochlear Implant Users | Other | Device: Existing bilateral cochlear implantsAdults with existing bilateral cochlear implants (implanted and using their devices for at least one year). Participants complete the discrimination and selective-attention auditory paradigms with manipulated spatial cues while combined EEG, fNIRS, and pupillometry are recorded. No fMRI is collected in this arm due to device safety concerns. |
| Normal Hearing Controls | Other | Other: Normal Hearing ControlAdults with audiometrically confirmed normal hearing (thresholds within 20 dB HL of normal through 8 kHz). Participants complete three auditory attention paradigms (working memory, discrimination, selective attention) with manipulated spatial cues, under combined EEG, fNIRS, and pupillometry sessions and fMRI sessions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with normal hearing, confirmed by audiometric assessment (thresholds within 20 dB HL of normal through 8 kHz), OR adults with bilateral cochlear implants who have used their implants for at least one year
- Native speakers of American English
- Normal or corrected-to-normal vision
Key exclusion criteria (2 listed)
- Known neurological disorders
- For fMRI sessions (normal-hearing participants only): contraindications to MRI scanning; cochlear implant users do not complete MRI sessions
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 |
|---|---|---|
| Existing bilateral cochlear implantsParticipants in this arm are recruited from a population who have existing bilateral cochlear implants. The implants are the participants' own clinical devices, used as clinically programmed; no investigational device or modification is provided by the study. Auditory attention tasks are presented with manipulated spatial cues (interaural time differences, interaural level differences, or HRTFs). | Device | Bilateral Cochlear Implant Users |
| Normal Hearing ControlControl group recruited from the normal hearing population. Participants perform the same auditory attention tasks with manipulated spatial cues (interaural time differences, interaural level differences, or HRTFs) under EEG/fNIRS/pupillometry and fMRI. | Other | Normal Hearing Controls |
Primary outcome
EEG
Time frame: 2 hours
EEG data acquired using 32 Ag-Ag/Cl electrodes embedded in an elastic cap (Brain Products), impedances below 20 kOhms, locations per the extended 10-20 system, recorded at 5 kHz from 0.1-100 Hz. Event-related potentials (including attentional modulation of the N1) and parietal alpha lateralization are compared across spatial-cue and task-demand conditions.
NIRS
Time frame: 2 hours
Functional near-infrared spectroscopy collected with a montage targeting bilateral superior temporal gyrus (STG) and bilateral prefrontal cortex, using a NIRSport 2 8x8 channel system (NIRx) with long- and short-distance channel probes; 3D structural head scanning registers probe placement. Optical signals recorded at 10 Hz with an average source-detector distance of 35 mm. Oxygenated and deoxygenated hemoglobin responses are compared across conditions.
Pupillometry
Time frame: 2 hours
Pupil dilation from both eyes recorded with the EyeLink 1000 at a sampling rate of 1000 Hz, normalized to each participant pupillary dynamic range, as an index of listening effort across conditions.
MRI
Time frame: 2 hours
Data acquired on a 3 Tesla Siemens Prisma MRI scanner (64-channel head coil). High-resolution (0.8 mm iso) T1-weighted multi-echo MP-RAGE and T2-weighted SPACE images collected for cortical reconstruction (FreeSurfer); functional MRI measures stimulus-induced lateralization and spatial receptive fields in auditory cortex. Normal-hearing arm only.
Discrimination (DISCR)
Time frame: 2 hours
Behavioral discrimination performance for spatialized sounds. HRTFs span +/- 90 degrees, broadband ILDs span +/- 20 dB, and broadband ITDs span +/- 800 microseconds; values chosen to roughly equate perceived lateral range across cues.
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 14 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary measures (behavioral, EEG, fNIRS, pupillometry, and MRI) will be publicly shared in BIDS-compliant format, per the NIH Data Management and Sharing Plan for this award. Smaller datasets (demographics, behavioral scores) will be shared as text/CSV files via GitHub and permanently archived on Zenodo; larger neuroimaging datasets will be shared on Zenodo directly, with permanent DOIs. Custom acquisition and analysis software will also be shared via GitHub and archived on Zenodo.
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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.
Christopher A Brown, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Existing bilateral cochlear implants in people with Bilateral Cochlear Implants and Hearing Loss, Bilateral, run by University of South Florida 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 3 inclusion and 2 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 14 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 Christopher A Brown, PhD (412-670-2772, cb43@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: 2 hours). 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 14 Aug 2026.