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Noninvasive Cochlear Stimulation System

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05112809
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
29
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cochlear Stimulation System (CSS)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Noninvasive Cochlear Stimulation System
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Normal hearing subjects

Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system.

Device: Cochlear Stimulation System (CSS)
Cochlear stimulation with surround sound and noise cancellation
Experimental: Bilateral hearing impaired

Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system.

Device: Cochlear Stimulation System (CSS)
Cochlear stimulation with surround sound and noise cancellation
Experimental: Asymmetrical hearing-impaired

Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system.

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

Outcome Measures

Primary Outcome Measures

  1. Perception threshold [Baseline, approximately 2 hours]

    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).

  2. Speech Intelligibility [Baseline, approximately 2 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Michael J Cevette, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Michael Cevette, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05112809
Other Study ID Numbers:
  • 21-007158
First Posted:
Nov 9, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Michael Cevette, Principal Investigator, Mayo Clinic
Normal hearing

Study Results

No Results Posted as of Jun 10, 2022