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NCT05112809 Clinical Trial

Noninvasive Cochlear Stimulation System

Healthy Clinical Trial

Official title:
Noninvasive Cochlear Stimulation System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05112809
Other study ID # 21-007158
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 6, 2023
Est. completion date January 2025

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to develop a portable wearable hardware headset using a computer-based software that can establish the optimal stimulation parameters appropriate for medical and consumer environments for individuals with hearing impaired and normal hearing individuals.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria: - Employee of Mayo Clinic. Exclusion Criteria: - Pregnant. - Cochlear implants. - History of fluctuating sensorineural hearing loss. - Skin diseases of the head. - History of acute paroxysmal tachycardia. - History of trigeminal neuralgia. - Recent of paralysis of the facial nerve. - Recent cerebrovascular stroke.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cochlear Stimulation System (CSS)
Cochlear stimulation with surround sound and noise cancellation

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perception threshold Evaluated by increasing the amplitude of the current input until the subject can hear a tone. The threshold will be recorded as the perception threshold at that electrode pair and frequency. Reported in hertz (Hz). Baseline, approximately 2 hours
Primary Speech Intelligibility Measured using the modified rhyme test (MRT) consisting of a set of 50 six-item wordlist. Each word list contains single syllable words with a consonant-vowel-consonant sound sequence. Baseline, approximately 2 hours
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