Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus
Trial ID: NCT06083519
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-12-01
Completion date: 2026-11-01
Sponsor: Toronto Metropolitan University
Collaborators: Lucid, Inc.; Sonova Canada Inc.; Mitacs
Conditions: Tinnitus
Interventions: White Noise; Music and Auditory Beat Stimulation
Locations: Toronto Metropolitan University
Countries: Canada
Enrollment: 50
Age range: 40 Years - 85 Years
Sex: ALL

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 sufferers' quality of life. The main questions it aims to answer are: • \[question 1: to assess the efficacy of the LUCID/VIBE in managing the tinnitus handicap (measured by the reducing of the annoyance/stress response to tinnitus) contributing to the improvement of the quality of life of people living with tinnitus\] and • \[question 2: assess the efficacy of LUCID/VIBE in providing temporary relief through masking, such that it results in a reduction of the perceived loudness of tinnitus\]. Participants will \[use the VIBE app for 24 minutes a day for a period of 4 weeks. There will be two conditions, a Noise condition (the control condition in which the investigator will administer white noise) and the VIBE condition (the treatment condition). One approach involves broad-band masking with noise (Noise Condition), while the other uses music (LUCID Condition). Implementation of the noise condition will mirror the LUCID condition in terms of ease of access, look, feel, so that one condition does not look less professional than the other. Both conditions will be administered through the same app, and only the sound conditions will differ (white noise vs. LUCID music). All participants will be exposed to both the treatment and control conditions with the order of conditions counter-balanced (i.e., a cross-over design).

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 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.

Outcomes:
Tinnitus Functional Index; 36-item Short Form Health Survey