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

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).

Conditions

• Tinnitus

Interventions

BEHAVIORAL

White Noise

This is the control condition. Listening to white noise -- participants listen to white noise for 24 minutes

BEHAVIORAL

Music and Auditory Beat Stimulation

Listening to music and auditory beat stimulation. The VIBE app (LUCID) incorporates theta-band (4 Hz) auditory beat stimulation and an auditory music recommendation system. Participants will listen to this music with theta auditory beat stimulation for 24 minutes.

Sponsors & Collaborators

• Lucid, Inc.

  collaborator INDUSTRY

• Sonova Canada Inc.

  collaborator INDUSTRY

• Mitacs

  collaborator INDUSTRY

• Toronto Metropolitan University

  lead OTHER

Principal Investigators

• Brandon Paul, PhD · Toronto Metropolitan University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2026-11-01

Completion

2026-11-01

Countries

• Canada

Study Locations