CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
White Noise +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06083519
NCT06083519N/ACompleted

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

Toronto Metropolitan University·interventional·Posted Oct 16, 2023·Updated May 28, 2026

In Brief

A clinical study evaluating White Noise and Music and Auditory Beat Stimulation for Tinnitus. Completed, enrolled 54 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
CountriesCanada

Timeline

N/ACompletedFinished
202420252026
First PostedOct 16, 2023
Enrollment StartDec 1, 2024
Primary CompletionMay 15, 2026
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 2.7 years ago

Interventions

White Noisebehavioral

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

Music and Auditory Beat Stimulationbehavioral

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.