Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss

NCT05107466 | Recruiting

• 1 other identifier: STUDY02001061
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorineural Hearing Loss; Hearing Loss

Keywords

cochlear implant

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 minutes

Secondary Outcomes (8)

• Difference in Gap Detection Thresholds as a measure of auditory processing.

  15 min

• Difference in cochlear implant sound quality perception as measured by survey responses from participants with cochlear implants.

  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.

  45 minutes

• Difference in completion times for the Trail Making Test between individuals with hearing loss and normal hearing controls.

  5 min

• Difference in Controlled Oral Word Fluency Test scores between individuals with hearing loss and normal hearing controls.

  5 min

Study Arms (2)

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.

Diagnostic Test: P300 Visually evoked potential

Individuals with Normal Hearing

40 adults (\>18 y/o) without a diagnosis of hearing loss.

Diagnostic Test: P300 Visually evoked potential

Interventions

P300 Visually evoked potential DIAGNOSTIC_TEST

Measurement of the late cortical response, P300 potential to visually evoked stimuli using an oddball paradigm.

Individuals with Hearing Loss; Individuals with Normal Hearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (\>18 y/o) with or without a diagnosis of hearing loss.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James E Saunders, MD

  Department of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaela M Geffert, BS

CONTACT

6036502054; Michaela.M.Geffert@hitchcock.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otology and Neurotology, Department of Otolaryngology

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: July 28, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)