Status:
RECRUITING
Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus
Lead Sponsor:
Toronto Metropolitan University
Collaborating Sponsors:
Lucid, Inc.
Sonova Canada Inc.
Conditions:
Tinnitus
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to assess the effectiveness of a sound-based passive treatment for reducing stress and annoyance induced by tinnitus, and how this therapy may improve tinnitus suffe...
Detailed Description
The current LUCID approach utilizes the VIBE app to help provide a mask for tinnitus, manage the distress related to tinnitus, and potentially dampen stress reactivity when used regularly due to the i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06083519
Start Date
December 1 2024
End Date
November 1 2026
Last Update
September 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Toronto Metropolitan University
Toronto, Ontario, Canada, M5B 2K3