ClinConnect ClinConnect Logo
Search / Trial NCT06083519

Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus

Launched by TORONTO METROPOLITAN UNIVERSITY · Oct 5, 2023

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Tinnitus Iso Principle Artificial Intelligence Auditory Perception Sound Therapy Neuroscience Neuromodulatory Intervention Auditory Beat Stimulation

ClinConnect Summary

This clinical trial is studying a new sound-based treatment to help people who experience tinnitus, a condition that causes ringing or buzzing in the ears. The goal is to see if this treatment can reduce the stress and annoyance that comes with tinnitus and improve the overall quality of life for those affected. Participants will use an app called VIBE for 24 minutes a day over four weeks. They will listen to either calming music (the treatment condition) or white noise (the control condition) to compare how each sound affects their tinnitus symptoms.

To be eligible for the trial, participants should be between 50 and 80 years old, have a certain level of hearing loss in their better ear, and have been experiencing chronic tinnitus for more than three months. Those who are currently receiving other treatments for tinnitus will not be able to join, as it’s important to clearly understand the effects of this new app without other influences. If you or someone you know fits these criteria and is interested in learning more, this could be a great opportunity to help explore new ways to manage tinnitus.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Pure-Tone Average hearing loss (500, 1000, 2000, 4000) of 30 decibels hearing loss or greater in the better ear.
  • Tinnitus Handicap Index scores of 18 to 76 (mild to severe handicap).
  • Self-report of chronic, non-intermittent tinnitus experienced \> 3 months
  • Exclusion Criteria:
  • Adults younger than 50 years old, or adults older than 80 years old.
  • Pulsatile tinnitus (tinnitus that modulates synchronously with a participant's pulse)
  • \>20 dB HL difference in pure-tone average between ears
  • \> 80 dB HL PTA averaged across ears
  • Individuals currently undergoing other tinnitus treatment programs will not be able to participate in our study. This is to ensure that our findings are accurately attributed to our App and not influenced by external factors. If someone is already receiving treatment for their tinnitus, it would be challenging to distinguish the effects of our App from their existing treatment regimen. To eliminate the possibility of such confounding factors, our team kindly asks participants to disclose if they are undergoing other treatments for tinnitus.

About Toronto Metropolitan University

Toronto Metropolitan University (TMU) is a leading urban institution dedicated to fostering innovative research and academic excellence. As a clinical trial sponsor, TMU leverages its interdisciplinary expertise and cutting-edge facilities to conduct impactful research that addresses pressing health challenges. Through collaboration with healthcare professionals, industry partners, and community stakeholders, TMU aims to translate scientific discoveries into practical solutions, enhancing patient care and advancing public health. Committed to ethical standards and rigorous methodologies, TMU ensures the integrity and reliability of its clinical trials, contributing to the advancement of medical knowledge and practice.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Brandon Paul, PhD

Principal Investigator

Toronto Metropolitan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported