New sound-based treatment for managing tinnitus distress
Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus
This study is testing a new app that uses sound to see if it can help people with tinnitus feel less stressed and annoyed by their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Toronto Metropolitan University Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06083519 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a sound-based passive treatment using the VIBE app to reduce stress and annoyance caused by tinnitus. Participants will use the app for 24 minutes daily over four weeks, comparing its effects against a control condition of white noise. The study aims to assess both the reduction of tinnitus-related distress and the temporary relief of perceived loudness through auditory stimulation. The approach integrates artificial intelligence and music therapy principles to enhance the quality of life for tinnitus sufferers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 to 80 with chronic, non-intermittent tinnitus and a moderate to severe tinnitus handicap.
Not a fit: Patients with pulsatile tinnitus or those currently undergoing other tinnitus treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from tinnitus by reducing their distress and annoyance levels.
How similar studies have performed: Previous studies have shown promise in using sound therapy and music interventions for managing stress and anxiety, suggesting potential success for this novel approach to tinnitus.
Eligibility criteria
Show full inclusion / exclusion 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 40 years old, or adults older than 85 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.
Where this trial is running
Toronto, Ontario
- Toronto Metropolitan University — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Brandon Paul, PhD — Toronto Metropolitan University
- Study coordinator: Kay Wright-Whyte, MSc
- Email: kww@torontomu.ca
- Phone: 4169795000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.