Cochlear ImplantNCT07678879
Patient-Oriented Research to Optimize Cochlear Implant Outcomes
A study testing AC Group and CA group in people with Cochlear Implant and Cochlear Implant Users, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The rationale is that only through understanding how individual Cochlear Implant (CI) patients respond to interventions investigators further develop precision-medicine approaches to optimize outcomes. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cochlear Implant, Cochlear Implant Users, Cochlear Implant Recipients
- What is being tested?
- AC Group and CA group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jun 2032
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between ages of 18 years and 95 years
- Native language is American English
- Have one or two CIs from any of the three FDA-approved CI manufacturers (Cochlear Americas, Advanced Bionics, MED-EL).
- Experience of >6 of CI use.
Who cannot join
- Score 24 or below on a visual Mini-Mental State Exam (MMSE; Folstein et al., 1975) to rule out dementia
- Known diagnosis of dementia
- Under the age of 18 years
- Unable to read and write in English (WRAT score <70)
- Poorer than 20/40 near vision on near-vision screening.
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
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Saumil Shah, +1 (615)421-4165, saumil.m.shah@vumc.org
Aaron Moberly, MD
About this study
The rationale is that only through understanding how individual Cochlear Implant (CI) patients respond to interventions investigators further develop precision-medicine approaches to optimize outcomes. In the proposed research study to investigate the hypotheses, investigators will address two Specific Aims:
Specific Aim #1: Define the auditory (bottom-up), cognitive-linguistic (top-down), and functional neuroimaging profiles of adult CI users. Investigators will enroll experienced CI users (> 6 months of CI use).
Read more
Specific Aim #2: Determine the feasibility of "auditory" (bottom-up) and "cognitive" (top-down) interventions to improve speech processing in adult CI users.
The main hypothesis is that the two interventions are feasible. Investigators also hypothesize that our study protocol will detect the variance in auditory processing profiles and that investigators will show promise in improving both speech processing (using speech recognition and Functional Near-Infrared Spectroscopy (fNIRS) responses)) and real-world functioning (using patient-reported measures), compared with no intervention.
Additional hypotheses to be explored are that baseline profile (as defined in Aim #1) will impact the magnitude of participants' responses to the interventions, as will order of interventions (Auditory-Cognitive vs. Cognitive-Auditory, AC vs CA).
Read the detailed description
Specific Aim 1: Along with collection of demographic/audiologic and datalogging variables, participants will be tested for auditory spectro-temporal resolution and cognitive-linguistic functions. Functional near-infrared spectroscopy (fNIRS) will be collected, reflecting cortical responses to speech.
Using cluster analyses, investigators will test the hypothesis that different profiles exist, with different CI users demonstrating different patterns of bottom-up processing, top-down processing, or both. Patient-reported outcomes of CI-related quality of life, communication, and satisfaction will also be assessed to relate speech recognition to broader real world functioning.
Specific Aim 2: The "auditory" intervention includes a two-pronged approach of, first, verifying fitting via upper stimulation levels shaped to electrically evoked stapedial reflex thresholds (eSRTs) and lower stimulation levels fit to CI-aided detection between 20 and 30 dB Hearing Loss (HL), and second, image-guided cochlear implant programming (IGCIP) to reduce CI channel interaction. The "cognitive" intervention consists of computerized auditory-cognitive training using a well-established home-based training program focused on improving speech recognition through engaging cognitive processes known to be integral for successful listening in challenging conditions.
CI users from Aim #1 will be randomized to one of three groups:
- Group 1 receives an auditory intervention followed by a cognitive intervention (AC group);
- Group 2 receives a cognitive intervention followed by an auditory intervention (CA group); or (3) Group 3 is a passive control group that does not receive an intervention (Control group).
- Conditions
- Cochlear Implant, Cochlear Implant Users, Cochlear Implant Recipients, Cochlear Implant Listeners
- Being tested
- AC Group, CA group
- Keywords
- CI users, CI, cochlear implant, cochlear implant user, cochlear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC GroupBehavioural
Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcomes.
The auditory intervention consists of two in person visits:
Visit 1: Measurement of electrically evoked stapedius reflex thresholds (eSRTs), which do not require active participant responses CI-aided detection testing using the participant's everyday map in a sound field Assessment of threshold and comfort levels. Audio will be recorded for responses for later analysis.
Visit 2: Image-Guided Cochlear Implant Programming (IGCIP). CT-guided programming to deactivate channels with potential cross-stimulation conducted by a trained audiologist as part of routine clinical practice. The patient will also undergo speed recognition testing.
At the midpoint visit, the AC Group will crossover to the CA Group Study Procedures.
CA groupBehavioural
Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcome measures.
Cognitive Intervention Procedures The cognitive intervention will be conducted remotely over 4 weeks, consisting of: Approximately 1 hour per day, 5 days per week, 20 sessions total.
Participants will complete training using a laptop or smartphone. Participants may receive in-person or remote training prior to intervention initiation.
At the midpoint visit, the CA Group will crossover to the AC Group Study Procedures.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Auditory Intervention (AC) | Active comparator | Those randomized to Group 1 will receive auditory training for 4 weeks prior to the crossover to the cognitive training. Receives: Behavioral: AC Group; Behavioral: CA group |
| Group 2 - Cognitive Intervention (CA) | Active comparator | Those randomized to Group 2 will receive cognitive training for 4 weeks prior to the crossover to the auditory training. Receives: Behavioral: AC Group; Behavioral: CA group |
| Group 3 - Control | No intervention | Group 3 will be the control group and not receive either training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration.
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration. This score is from 0 to 100% words correct.
Measured: at ~8 weeks study completion
Secondary outcomes (1)
Cochlear Implant Quality of Life (CIQOL-35)
This measures assesses six domains: communication, emotional, entertainment, environment, listening effort, and social. Each domain is scored between 0 and 100 points.
Measured: at ~8 weeks study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- CI users from Aim #1 will be randomized to one of three groups: 1. Group 1 receives an auditory intervention followed by a cognitive intervention (AC group); 2. Group 2 receives a cognitive intervention followed by an auditory intervention (CA group); or (3) Group 3 is a passive control group that does not receive an intervention (Control group).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Moberly, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678879
- Sponsor's protocol ID
- 260536
- Status last verified
- Aug 2026
- First submitted
- 9 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a feasibility study. De-identified individual participant data (IPD) collected in this study may be available to other researchers (e.g., outside the primary research group) Data may be shared with others if requested and necessary agreements are made. This is still undecided as this is a feasibility trial.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Oriented Research to Optimize Cochlear Implant Outcomes
- ClinicalTrials.gov ID
- NCT07678879
- Acronym / sponsor ID
- 260536
- Conditions
- Cochlear Implant, Cochlear Implant Users, Cochlear Implant Recipients, Cochlear Implant Listeners
- Keywords
- CI users, CI, cochlear implant, cochlear implant user, cochlear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 1 Jul 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.
The rationale is that only through understanding how individual Cochlear Implant (CI) patients respond to interventions investigators further develop precision-medicine approaches to optimize outcomes. In the proposed research study to investigate the hypotheses, investigators will address two Specific Aims:
Specific Aim #1: Define the auditory (bottom-up), cognitive-linguistic (top-down), and functional neuroimaging profiles of adult CI users. Investigators will enroll experienced CI users (> 6 months of CI use).
Specific Aim #2: Determine the feasibility of "auditory" (bottom-up) and "cognitive" (top-down) interventions to improve speech processing in adult CI users.
The main hypothesis is that the two interventions are feasible. Investigators also hypothesize that our study protocol will detect the variance in auditory processing profiles and that investigators will show promise in improving both speech processing (using speech recognition and Functional Near-Infrared Spectroscopy (fNIRS) responses)) and real-world functioning (using patient-reported measures), compared with no intervention.
Additional hypotheses to be explored are that baseline profile (as defined in Aim #1) will impact the magnitude of participants' responses to the interventions, as will order of interventions (Auditory-Cognitive vs. Cognitive-Auditory, AC vs CA).
Detailed description
Specific Aim 1: Along with collection of demographic/audiologic and datalogging variables, participants will be tested for auditory spectro-temporal resolution and cognitive-linguistic functions. Functional near-infrared spectroscopy (fNIRS) will be collected, reflecting cortical responses to speech.
Using cluster analyses, investigators will test the hypothesis that different profiles exist, with different CI users demonstrating different patterns of bottom-up processing, top-down processing, or both. Patient-reported outcomes of CI-related quality of life, communication, and satisfaction will also be assessed to relate speech recognition to broader real world functioning.
Specific Aim 2: The "auditory" intervention includes a two-pronged approach of, first, verifying fitting via upper stimulation levels shaped to electrically evoked stapedial reflex thresholds (eSRTs) and lower stimulation levels fit to CI-aided detection between 20 and 30 dB Hearing Loss (HL), and second, image-guided cochlear implant programming (IGCIP) to reduce CI channel interaction. The "cognitive" intervention consists of computerized auditory-cognitive training using a well-established home-based training program focused on improving speech recognition through engaging cognitive processes known to be integral for successful listening in challenging conditions.
CI users from Aim #1 will be randomized to one of three groups:
- Group 1 receives an auditory intervention followed by a cognitive intervention (AC group);
- Group 2 receives a cognitive intervention followed by an auditory intervention (CA group); or (3) Group 3 is a passive control group that does not receive an intervention (Control group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- CI users from Aim #1 will be randomized to one of three groups: 1. Group 1 receives an auditory intervention followed by a cognitive intervention (AC group); 2. Group 2 receives a cognitive intervention followed by an auditory intervention (CA group); or (3) Group 3 is a passive control group that does not receive an intervention (Control group).
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Auditory Intervention (AC) | Active comparator | Behavioral: AC Group, Behavioral: CA groupThose randomized to Group 1 will receive auditory training for 4 weeks prior to the crossover to the cognitive training. |
| Group 2 - Cognitive Intervention (CA) | Active comparator | Behavioral: AC Group, Behavioral: CA groupThose randomized to Group 2 will receive cognitive training for 4 weeks prior to the crossover to the auditory training. |
| Group 3 - Control | No intervention | –Group 3 will be the control group and not receive either training. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between ages of 18 years and 95 years
- Native language is American English
- Have one or two CIs from any of the three FDA-approved CI manufacturers (Cochlear Americas, Advanced Bionics, MED-EL).
- Experience of >6 of CI use.
Key exclusion criteria (5 listed)
- Score 24 or below on a visual Mini-Mental State Exam (MMSE; Folstein et al., 1975) to rule out dementia
- Known diagnosis of dementia
- Under the age of 18 years
- Unable to read and write in English (WRAT score <70)
- Poorer than 20/40 near vision on near-vision screening.
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 |
|---|---|---|
| AC GroupFollowing completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcomes. The auditory intervention consists of two in person visits: Visit 1: Measurement of electrically evoked stapedius reflex thresholds (eSRTs), which do not require active participant responses CI-aided detection testing using the participant's everyday map in a sound field Assessment of threshold and comfort levels. Audio will be recorded for responses for later analysis. Visit 2: Image-Guided Cochlear Implant Programming (IGCIP). CT-guided programming to deactivate channels with potential cross-stimulation conducted by a trained audiologist as part of routine clinical practice. The patient will also undergo speed recognition testing. At the midpoint visit, the AC Group will crossover to the CA Group Study Procedures. | Behavioural | Group 1 - Auditory Intervention (AC), Group 2 - Cognitive Intervention (CA) |
| CA groupFollowing completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcome measures. Cognitive Intervention Procedures The cognitive intervention will be conducted remotely over 4 weeks, consisting of: Approximately 1 hour per day, 5 days per week, 20 sessions total. Participants will complete training using a laptop or smartphone. Participants may receive in-person or remote training prior to intervention initiation. At the midpoint visit, the CA Group will crossover to the AC Group Study Procedures. | Behavioural | Group 1 - Auditory Intervention (AC), Group 2 - Cognitive Intervention (CA) |
Primary outcome
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration.
Time frame: at ~8 weeks study completion
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration. This score is from 0 to 100% words correct.
1 secondary outcome
Cochlear Implant Quality of Life (CIQOL-35)
Time frame: at ~8 weeks study completion
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 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. This is a feasibility study. De-identified individual participant data (IPD) collected in this study may be available to other researchers (e.g., outside the primary research group) Data may be shared with others if requested and necessary agreements are made. This is still undecided as this is a feasibility trial.
Related trials for Cochlear Implant
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An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AC Group and CA group in people with Cochlear Implant and Cochlear Implant Users, run by Vanderbilt University Medical Center 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Sep 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 Saumil Shah (+1 (615)421-4165, saumil.m.shah@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration. (time frame: at ~8 weeks study completion). 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 22 Sep 2026.