Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05107466
Collaborator
Dartmouth College (Other)
80
1
2
22
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: P300 Visually evoked potential
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss
Actual Study Start Date :
Dec 31, 2021
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Cochlear implant, good performer

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).

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

Other: Cochlear implant, poor performer

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.

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

Outcome Measures

Primary Outcome Measures

  1. Difference in mean VEP latency as measured by onset time of the P300 wave from time of stimuli presentation. [15 minutes]

    Difference in P300 VEP latency to odd ball paradigm visual stimuli in good vs poor performing Cochlear implant users as determined by AZBio sentence testing with <60% score qualifying as "poor performance." Difference in VEP latency will be measured by recording onset time of the P300 signal from time of stimuli presentation.

  2. 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, [15 minutes]

    Difference in mean VEP amplitude to odd ball paradigm visual stimuli in good vs poor performing Cochlear implant users as determined by AZBio sentence testing with <60% score qualifying as "poor performance." Differences in VEP amplitude will be measure by recording maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero.

Secondary Outcome Measures

  1. Difference in mean AEP latency as measured by onset time of the P300 wave from time of stimuli presentation. [15 min]

    Difference in P300 VEP latency to odd ball paradigm visual stimuli in good vs poor performing Cochlear implant users as determined by AZBio sentence testing with <60% score qualifying as "poor performance." Difference in AEP latency will be measured by recording onset time of the P300 signal from time of stimuli presentation.

  2. Difference in mean AEP amplitude as measured by the maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero. [15 minutes]

    Difference in mean AEP amplitude to odd ball paradigm visual stimuli in good vs poor performing Cochlear implant users as determined by AZBio sentence testing with <60% score qualifying as "poor performance." Differences in AEP amplitude will be measure by recording maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero.

  3. Difference in augmented reality testing as measured by the signal-to-noise ratio of the volume (measured in decibels) of spoken sentences to the volume of background noise. [30 min.]

    Differences in augmented reality testing measures in good vs poor performing Cochlear implant users as determined by AZBio sentence testing with <60% score qualifying as "poor performance." Differences in augmented reality testing measures will be measured by the signal to noise ration (SNR) of the spoken-sentences volume to background noise volume. Both volumes will be measured in decibels.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03766

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center
  • Dartmouth College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James E. Saunders, Professor of Otology and Neurotology, Department of Otolaryngology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT05107466
Other Study ID Numbers:
  • STUDY02001061
First Posted:
Nov 4, 2021
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by James E. Saunders, Professor of Otology and Neurotology, Department of Otolaryngology, Dartmouth-Hitchcock Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2022