Sensorineural Hearing LossNCT05107466
Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss
An observational study of Sensorineural Hearing Loss and Hearing Loss, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This research is being done to determine whether a test that measures a "Visual Evoked Potential" can be used in a new way for individuals that have hearing loss. This test measures the participant's brain's response (so called "brain waves") to specific visual images. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss, Hearing Loss
- What is being tested?
- P300 Visually evoked potential
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 1 Oct 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (>18 y/o) with or without a diagnosis of hearing loss.
Who may be able to join
- Subjects will be recruited from the Otolaryngology/Audiology clinic at DHMC with the goal of enrolling subjects with a variety of degrees of hearing loss and central auditory processing dysfunction.
- Age > 18 y/o.
- Current and new patients receiving care in the DHMC Otolaryngology clinic or from the employees of Dartmouth College, DHMC, and the community, will be included as allowed under COVID guidelines.
Who cannot join
- Patients with known brain pathology (e.g., CNS tumors, CVA diagnosis, etc…) will be excluded.
- Patients with severe neurological or neuropsychological disorders will be excluded.
- Patients with known seizure history will be excluded.
- Patients with known blindness will be excluded.
- The following special populations will not be included:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
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
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Michaela M Geffert, BS, 6036502054, Michaela.M.Geffert@hitchcock.org
About this study
This research is being done to determine whether a test that measures a "Visual Evoked Potential" can be used in a new way for individuals that have hearing loss. This test measures the participant's brain's response (so called "brain waves") to specific visual images. This study will help the investigators determine whether this test could be used to improve treatments for patients with hearing loss.
The "Visual Evoked Potential" measurement test is already used in the investigator's Neurology clinic at Dartmouth Hitchcock Medical Center for various conditions to measure "early" brain responses that occur in the first 1-2 seconds after a new cue. Our research aims to explore your brain's response just after that early 1-2 second period by looking at a specific response called the "P300". The P300 wave is a brain response to new or different images or sounds. A visual evoked P300 has not been studied in individuals with hearing loss.
The investigators will compare the results of this test to standard auditory tests, tests of cognitive function, and cochlear implant patient outcomes to explore how these factors can predict successful use of a hearing aid or cochlear implant.
Read the detailed description
Participants will schedule two appointments, at times convenient to the participant, to come to the testing clinic to complete the Visual Evoked Potential testing as well as the auditory test, cognitive/mood assessment battery, and sound quality survey included in this study.
The first research appointment will include a test of the participant's vision that involves looking at a chart on a wall and identifying appropriate letters. After this brief visual test, the participant will complete VEP testing.
For the VEP portion of the testing, participants will sit in a comfortable chair and have electrodes placed at several locations on their scalp. Electrodes are stickers that connect to a wire that connects to a computer. Electrodes do not break the skin or commonly cause any discomfort or harm. Participants will sit for approximately 1 hour and watch images presented to them on a computer screen while the participant's brain's response is measured using a computer. A picture of the electrodes on the participant's head will be taken for precise electrode localization.
The second research appointment will consist of an auditory test, a cognitive/mood assessment, and a cochlear implant sound quality survey. The survey will only be completed by participants with a cochlear implant. The auditory testing portion will take place in the Audiology clinic and requires participants to listen and respond to different patterns of sound. While participants are at the clinic for testing, they will be asked to complete several questionnaires that ask about participant's mood and thought processing. Participants with cochlear implants will also be asked to complete a questionnaire about their perceived sound quality with their implant(s).
The Visual Evoked Potential measure, auditory test results, cognitive/mood assessment, and cochlear implant sound quality survey responses will be compared between "hearing loss" and "normal hearing" groups to determine if VEP testing can be used in a new way to predict successful use of a cochlear implant or hearing aid.
- Conditions
- Sensorineural Hearing Loss, Hearing Loss
- Being tested
- P300 Visually evoked potential
- Keywords
- cochlear implant
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P300 Visually evoked potentialDiagnostic test
Measurement of the late cortical response, P300 potential to visually evoked stimuli using an oddball paradigm.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Hearing Loss | 60 adults (>18 y/o) with a diagnosis of hearing loss. These participants may use cochlear implant(s), hearing aid(s), or have unaided hearing loss. Receives: Diagnostic Test: P300 Visually evoked potential | |
| Individuals with Normal Hearing | 40 adults (>18 y/o) without a diagnosis of hearing loss. Receives: Diagnostic Test: P300 Visually evoked potential |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean VEP latency as measured by onset time of the P300 wave from time of stimuli presentation.
Difference in P300 VEP latency to odd ball paradigm visual stimuli in individuals with hearing loss and normal hearing controls. Differences in VEP latency will be measured by recording onset time of the P300 signal from time of stimuli presentation.
Measured: 30 minutes
Difference in mean VEP amplitude as measured by the maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero.
Difference in mean VEP amplitude to odd ball paradigm visual stimuli in individuals with hearing loss and normal hearing controls. Differences in VEP amplitude will be measured by recording maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero.
Measured: 30 minutes
Secondary outcomes (8)
Difference in Gap Detection Thresholds as a measure of auditory processing.
Difference in Gap Detection Thresholds between individuals with hearing loss and normal hearing controls. Thresholds (in ms) will be measured and calculated using a software developed by a local engineering company (Creare) in a DHMC Audiology clinic sound booth.
Measured: 15 min
Difference in cochlear implant sound quality perception as measured by survey responses from participants with cochlear implants.
Participants with cochlear implants will be asked to complete a subjective survey to provide detail about their experience with cochlear implant(s). The survey responses contain both multiple choice answers and continuous rating scales to allow participants to answer questions pertaining to their perception of music, voices, meditative sounds, and general sound perception. The survey is not a scored on a scale, but is instead meant to capture a participant's unique, subjective perception of sound.
Measured: 10 min
Difference in scores for the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing-impaired individuals (RBANS-H) between individuals with hearing loss and normal hearing controls.
The RBANS-H is a cognitive assessment battery that consists of the 12 following items: List Learning, Story Memory, Figure Copy, Line Orientation, Picture Naming, Semantic Fluency, Digit Span, Coding, List Recall, List Recognition, Story Recall, and Figure Recall. The minimum (worst) RBANS-H score is 0 and the maximum (best) RBANS-H score is 321.
Measured: 45 minutes
Difference in completion times for the Trail Making Test between individuals with hearing loss and normal hearing controls.
The Trail Making Test is a standard neuropsychological assessment that requires a pen and paper. Part A requires that participants connect randomly placed numbers in ascending order. Part B requires that participants connect randomly placed numbers and letters in alternating numerical/alphabetical order. The Trail Making Test is scored by time (i.e. minutes:seconds). Faster completions of the test are better outcomes than slower completions.
Measured: 5 min
Difference in Controlled Oral Word Fluency Test scores between individuals with hearing loss and normal hearing controls.
The Controlled Oral Word Fluency Test is a standard neurocognitive assessment. Participants are given one minute to generate as many words as possible that start with a given letter of the alphabet. Better scores reflect a higher number of words provided, and worse scores reflect fewer words provided by the participant.
Measured: 5 min
Difference in scores for the Test of Premorbid Functioning between individuals with hearing loss and normal hearing controls.
The Test of Premorbid Functioning is a standard neurocognitive assessment that requires participants to read aloud from a list of pre-selected words. The total score is the number of words that the participant pronounces correctly. The minimum (worst) score for this assessment is 0, and the maximum (best) score is 70.
Measured: 5 min
Difference in scores for the Beck Depression Inventory-II (BDI-II) between individuals with hearing loss and normal hearing controls.
The Beck Depression Inventory-II is a standard depression scale. This assessment is a survey that contains 21 multiple choice questions. The highest possible score (with higher scores indicating more severe depression) is 63. The lowest possible score is 0.
Measured: 5 min
Difference in scores for the Beck Anxiety Inventory between individuals with hearing loss and normal hearing controls.
The Beck Anxiety Inventory is a standard anxiety scale. It consists of a list of 21 anxiety symptoms and asks participants to indicate how much they have been bothered by each symptom by choosing from the following options: "Not At All", "Mildly", "Moderately", "Severely".
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start28 Jul 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, James E. Saunders, Dartmouth-Hitchcock Medical Center
- Investigators
- James E Saunders, MD, Principal investigator, Department of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107466
- Sponsor's protocol ID
- STUDY02001061
- Status last verified
- Oct 2025
- First submitted
- 25 Oct 2021
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be available to researchers involved in this study only.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss
- ClinicalTrials.gov ID
- NCT05107466
- Acronym / sponsor ID
- STUDY02001061
- Conditions
- Sensorineural Hearing Loss, Hearing Loss
- Keywords
- cochlear implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 4 Nov 2021 (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.
This research is being done to determine whether a test that measures a "Visual Evoked Potential" can be used in a new way for individuals that have hearing loss. This test measures the participant's brain's response (so called "brain waves") to specific visual images. This study will help the investigators determine whether this test could be used to improve treatments for patients with hearing loss.
The "Visual Evoked Potential" measurement test is already used in the investigator's Neurology clinic at Dartmouth Hitchcock Medical Center for various conditions to measure "early" brain responses that occur in the first 1-2 seconds after a new cue. Our research aims to explore your brain's response just after that early 1-2 second period by looking at a specific response called the "P300". The P300 wave is a brain response to new or different images or sounds. A visual evoked P300 has not been studied in individuals with hearing loss.
The investigators will compare the results of this test to standard auditory tests, tests of cognitive function, and cochlear implant patient outcomes to explore how these factors can predict successful use of a hearing aid or cochlear implant.
Detailed description
Participants will schedule two appointments, at times convenient to the participant, to come to the testing clinic to complete the Visual Evoked Potential testing as well as the auditory test, cognitive/mood assessment battery, and sound quality survey included in this study.
The first research appointment will include a test of the participant's vision that involves looking at a chart on a wall and identifying appropriate letters. After this brief visual test, the participant will complete VEP testing.
For the VEP portion of the testing, participants will sit in a comfortable chair and have electrodes placed at several locations on their scalp. Electrodes are stickers that connect to a wire that connects to a computer. Electrodes do not break the skin or commonly cause any discomfort or harm. Participants will sit for approximately 1 hour and watch images presented to them on a computer screen while the participant's brain's response is measured using a computer. A picture of the electrodes on the participant's head will be taken for precise electrode localization.
The second research appointment will consist of an auditory test, a cognitive/mood assessment, and a cochlear implant sound quality survey. The survey will only be completed by participants with a cochlear implant. The auditory testing portion will take place in the Audiology clinic and requires participants to listen and respond to different patterns of sound. While participants are at the clinic for testing, they will be asked to complete several questionnaires that ask about participant's mood and thought processing. Participants with cochlear implants will also be asked to complete a questionnaire about their perceived sound quality with their implant(s).
The Visual Evoked Potential measure, auditory test results, cognitive/mood assessment, and cochlear implant sound quality survey responses will be compared between "hearing loss" and "normal hearing" groups to determine if VEP testing can be used in a new way to predict successful use of a cochlear implant or hearing aid.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with Hearing Loss | – | Diagnostic Test: P300 Visually evoked potential60 adults (>18 y/o) with a diagnosis of hearing loss. These participants may use cochlear implant(s), hearing aid(s), or have unaided hearing loss. |
| Individuals with Normal Hearing | – | Diagnostic Test: P300 Visually evoked potential40 adults (>18 y/o) without a diagnosis of hearing loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (>18 y/o) with or without a diagnosis of hearing loss.
Key inclusion criteria (3 listed)
- Subjects will be recruited from the Otolaryngology/Audiology clinic at DHMC with the goal of enrolling subjects with a variety of degrees of hearing loss and central auditory processing dysfunction.
- Age > 18 y/o.
- Current and new patients receiving care in the DHMC Otolaryngology clinic or from the employees of Dartmouth College, DHMC, and the community, will be included as allowed under COVID guidelines.
Key exclusion criteria (8 listed)
- Patients with known brain pathology (e.g., CNS tumors, CVA diagnosis, etc…) will be excluded.
- Patients with severe neurological or neuropsychological disorders will be excluded.
- Patients with known seizure history will be excluded.
- Patients with known blindness will be excluded.
- The following special populations will not be included:
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 |
|---|---|---|
| P300 Visually evoked potentialMeasurement of the late cortical response, P300 potential to visually evoked stimuli using an oddball paradigm. | Diagnostic test | Individuals with Hearing Loss, Individuals with Normal Hearing |
Primary outcome
Difference in mean VEP latency as measured by onset time of the P300 wave from time of stimuli presentation.
Time frame: 30 minutes
Difference in P300 VEP latency to odd ball paradigm visual stimuli in individuals with hearing loss and normal hearing controls. Differences in VEP latency will be measured by recording onset time of the P300 signal from time of stimuli presentation.
Difference in mean VEP amplitude as measured by the maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero.
Time frame: 30 minutes
Difference in mean VEP amplitude to odd ball paradigm visual stimuli in individuals with hearing loss and normal hearing controls. Differences in VEP amplitude will be measured by recording maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero.
8 secondary outcomes
Difference in Gap Detection Thresholds as a measure of auditory processing.
Time frame: 15 min
Difference in cochlear implant sound quality perception as measured by survey responses from participants with cochlear implants.
Time frame: 10 min
Difference in scores for the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing-impaired individuals (RBANS-H) between individuals with hearing loss and normal hearing controls.
Time frame: 45 minutes
Difference in completion times for the Trail Making Test between individuals with hearing loss and normal hearing controls.
Time frame: 5 min
Difference in Controlled Oral Word Fluency Test scores between individuals with hearing loss and normal hearing controls.
Time frame: 5 min
Difference in scores for the Test of Premorbid Functioning between individuals with hearing loss and normal hearing controls.
Time frame: 5 min
Difference in scores for the Beck Depression Inventory-II (BDI-II) between individuals with hearing loss and normal hearing controls.
Time frame: 5 min
Difference in scores for the Beck Anxiety Inventory between individuals with hearing loss and normal hearing controls.
Time frame: 5 min
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 29 Oct 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be available to researchers involved in this study only.
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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.
James E Saunders, MD principal investigator
Department of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss and Hearing Loss, run by Dartmouth-Hitchcock 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 3 inclusion and 8 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 29 Oct 2025. 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 Michaela M Geffert, BS (6036502054, Michaela.M.Geffert@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean VEP latency as measured by onset time of the P300 wave from time of stimuli presentation. (time frame: 30 minutes). The study lists 2 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 29 Oct 2025.