Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss

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Brief Title

Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss

Official Title

Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss

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 also compare the results of this test to standard hearing tests and to
      a similar P300 response to different sounds. Finally, the investigators will compare the
      results of those tests to a test that uses augmented reality to assess the participant's
      hearing function. This includes wearing a headset (like a heavy pair of glasses), and
      indicating what the participants heard by pointing to different options simply by looking at
      the target.
    

Detailed Description

      After being consented to participate in this study, participants will schedule a time,
      convenient to the participant, to come to the testing clinic to complete the Visually evoked
      potential (VEP) and Auditory evoked potential testing (AEP). If the participant hasn't had a
      hearing test in the last 6 months one will be scheduled as well. Participant's vision will be
      tested by looking a chart on a wall and identifying appropriate letters.

      For the VEP portion of the testing, participants will sit in a comfortable chair and have
      electrodes placed at several locations on the participant's 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 30 minutes and watch images presented to the participant on a computer
      screen while the participant's brain's response (visual) is measured using a computer.

      For the AEP testing participants will listen while presented with different sounds. The
      investigators will measure participant's brain response's for approximately 30 minutes
      (auditory).

      The augmented reality testing starts with participants seated comfortably. Participants will
      listen to auditory prompts and respond to sentences by looking at the correct target response
      displayed in front of the participant.

      Participants will also complete a battery of tests in the Audiology clinic that involve
      listening and responding to different sounds and patterns. While participants are at the
      clinic for testing participants will be asked to complete several questionnaires that ask
      about participant's mood and thought processing.

      Participants will receive a survey either via email or in the mail shortly after completing
      testing in our clinic. Participants can complete this survey at home and return it to the
      investigating team via email or pre-paid mail.
    


Study Type

Interventional


Primary Outcome

Difference in mean VEP latency as measured by onset time of the P300 wave from time of stimuli presentation.

Secondary Outcome

 Difference in mean AEP latency as measured by onset time of the P300 wave from time of stimuli presentation.

Condition

Sensorineural Hearing Loss

Intervention

P300 Visually evoked potential

Study Arms / Comparison Groups

 Cochlear implant, good performer
Description:  40 adults (>18 y/o) with Cochlear implants at least 6 months post implantation who score >60% on the clinically administered speech understanding score AZBIO (Arizona Bioindustry Association sentence test).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

80

Start Date

December 31, 2021

Completion Date

October 31, 2023

Primary Completion Date

October 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  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, as allowed under SARS-Co-V-2
             (severe acute respiratory syndrome coronavirus 2) guidelines.

        Exclusion Criteria:

          -  Patients with known brain pathology (e.g., CNS (central nervous system) tumors, CVA
             (cerebrovascular accident) diagnosis, etc…)

          -  Patients with known blindness

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Prisoners
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

James E Saunders, (210) 723-1843, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05107466

Organization ID

STUDY02001061


Responsible Party

Principal Investigator

Study Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

 Dartmouth College

Study Sponsor

James E Saunders, Principal Investigator, Department of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center


Verification Date

November 2021