NCT05107466 Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss
| NCT ID | NCT05107466 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dartmouth-Hitchcock Medical Center |
| Condition | Sensorineural Hearing Loss |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-07-28 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-07-28 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion * 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. Exclusion * 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
Contact & Investigator
James E Saunders, MD
PRINCIPAL INVESTIGATOR
Department of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center
Frequently Asked Questions
Who can join the NCT05107466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sensorineural Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05107466 currently recruiting?
Yes, NCT05107466 is actively recruiting participants. Contact the research team at Michaela.M.Geffert@hitchcock.org for enrollment information.
Where is the NCT05107466 trial being conducted?
This trial is being conducted at Lebanon, United States.
Who is sponsoring the NCT05107466 clinical trial?
NCT05107466 is sponsored by Dartmouth-Hitchcock Medical Center. The principal investigator is James E Saunders, MD at Department of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center. The trial plans to enroll 100 participants.