Actively Recruiting

Phase Not Applicable
Age: 40Years - 85Years
All Genders
NCT06083519

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

Led by Toronto Metropolitan University · Updated on 2025-09-15

50

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

T

Toronto Metropolitan University

Lead Sponsor

L

Lucid, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pure-Tone Average hearing loss of 30 decibels or greater in the better ear
  • Tinnitus Handicap Index scores between 18 and 76 (mild to severe handicap)
  • Chronic, continuous tinnitus experienced for more than 3 months
Not Eligible

You will not qualify if you...

  • Younger than 40 years old or older than 85 years old
  • Pulsatile tinnitus that matches the participant's pulse
  • More than 20 decibels hearing loss difference between ears
  • Pure-Tone Average hearing loss over 80 decibels averaged across both ears
  • Currently undergoing other tinnitus treatment programs

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Toronto Metropolitan University

Toronto, Ontario, Canada, M5B 2K3

Actively Recruiting

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Research Team

K

Kay Wright-Whyte, MSc

CONTACT

G

George Chan, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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