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Visual Evoked Potentials for Hearing Loss
N/A
Recruiting
Led By James E Saunders, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 y/o.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 minutes
Awards & highlights
Study Summary
This trial is being done to determine whether a test that measures a "Visual Evoked Potential" can be used to improve treatments for patients with hearing loss.
Who is the study for?
This trial is for adults over 18 with varying degrees of hearing loss, who are patients or employees at Dartmouth Hitchcock Medical Center (DHMC), or from the local community. It's not for those with blindness, brain tumors, history of strokes, severe neurological issues, seizures, and excludes certain groups like prisoners and minors.Check my eligibility
What is being tested?
The study tests if a 'Visual Evoked Potential' measurement can help in treating hearing loss by analyzing the brain's response to visual stimuli. Specifically looking at the P300 wave response after the initial reaction period to see if it can predict successful hearing aid or cochlear implant use.See study design
What are the potential side effects?
Since this trial involves non-invasive testing of brain responses to visual cues without medication or surgery, there are minimal expected side effects. However, discomfort from wearing testing equipment may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 45 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 latency as measured by onset time of the P300 wave from time of stimuli presentation.
Secondary outcome measures
Difference in Controlled Oral Word Fluency Test scores between individuals with hearing loss and normal hearing controls.
Difference in Gap Detection Thresholds as a measure of auditory processing.
Difference in cochlear implant sound quality perception as measured by survey responses from participants with cochlear implants.
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Individuals with Normal HearingExperimental Treatment1 Intervention
40 adults (>18 y/o) without a diagnosis of hearing loss.
Group II: Individuals with Hearing LossExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
522 Previous Clinical Trials
2,542,394 Total Patients Enrolled
Dartmouth CollegeOTHER
79 Previous Clinical Trials
1,415,474 Total Patients Enrolled
James E Saunders, MDPrincipal InvestigatorDepartment of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center
1 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I do not have severe brain or nerve disorders.I do not have any known brain conditions like tumors or stroke.I have never had a seizure.People with different levels of hearing loss and difficulty understanding sounds will be asked to join from the ear, nose, and throat clinic at DHMC.People getting treatment at the DHMC Otolaryngology clinic and those working at Dartmouth College, DHMC, and the community can join if permitted by COVID guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Individuals with Hearing Loss
- Group 2: Individuals with Normal Hearing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can additional participants join this research program?
"This medical research is still recruiting participants, as reported on clinicaltrials.gov which shows the trial was first announced on December 31st 2021 and most recently updated February 8th 2022."
Answered by AI
What is the target enrollment for this research endeavor?
"Affirmative. Details provided on clinicaltrials.gov verify that this scientific undertaking, which was launched on December 31st 2021, is actively recruiting volunteers. 80 participants are required to be recruited from 1 medical facility."
Answered by AI
Who else is applying?
What site did they apply to?
Dartmouth Hitchcock Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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