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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Toronto Metropolitan University
RECRUITING
Toronto
Contact Information
Primary
Kay Wright-Whyte, MSc
kww@torontomu.ca
4169795000
Backup
George Chan, PhD
george.chan@torontomu.ca
4169795000
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 50
Treatments
Sham_comparator: White Noise
Participants listened to white noise for 24 minutes
Experimental: LUCID Music
Participants listened to music chosen from the VIBE app with theta auditory beat stimulation for 24 minutes
Related Therapeutic Areas
Sponsors
Collaborators: Lucid, Inc., Mitacs, Sonova Canada Inc.
Leads: Toronto Metropolitan University

This content was sourced from clinicaltrials.gov