Recruiting

Observational Study

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT05107466

Conditions

Sensorineural Hearing Loss

Hearing Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

P300 Visually evoked potential

Study Details

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

Study ID

NCT05107466

Start date

Jul 28, 2023

Status verified date

Oct, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Individuals with Normal Hearing

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

Interventions

P300 Visually evoked potential

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

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Michaela M Geffert, BS

6036502054Michaela.M.Geffert@hitchcock.org

Locations

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Michaela M Geffert, BS

6036502054Michaela.M.Geffert@hitchcock.org

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • cochlear implant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2025-10-29.