Sound-based Treatment for Tinnitus

Overseen By George Chan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Toronto Metropolitan University

Disqualifiers: Age, Pulsatile tinnitus, Other treatments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a sound-based treatment called LUCID/VIBE to help people with tinnitus, a condition characterized by hearing ringing or buzzing without an external source. The study tests whether listening to music or white noise through an app can reduce the stress and annoyance caused by tinnitus and improve quality of life. Participants will use the app daily for four weeks, experiencing both types of sound. This trial suits those who have experienced constant tinnitus for more than three months and find it disruptive to daily life. As an unphased trial, it offers a unique opportunity to explore innovative sound therapies that could enhance daily living for tinnitus sufferers.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently undergoing other tinnitus treatments. This is to ensure the results are due to the trial's app and not other treatments.

What prior data suggests that this sound-based treatment is safe for tinnitus sufferers?

Research shows that the LUCID/VIBE sound-based treatment is being tested for safety and effectiveness in helping people with tinnitus. Earlier studies have shown promise in reducing stress and discomfort related to tinnitus through sound therapy via an app.

The treatment involves listening to specially selected music for a short time each day. Early results suggest participants generally tolerate this method well. Side effects, if any, have been minor, and the treatment is considered safe. The study reports no major safety concerns.

While more research is needed to confirm these findings, current evidence suggests that the LUCID/VIBE treatment could be a safe option for those seeking relief from tinnitus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sound-based treatment for tinnitus because it uses music chosen from the VIBE app combined with theta auditory beat stimulation, which is a fresh approach compared to traditional options like hearing aids or sound-masking devices. This treatment targets brainwave activity directly, potentially offering more precise relief from tinnitus symptoms. Unlike standard treatments that typically provide temporary masking of tinnitus sounds, this method aims to retrain the brain's response to tinnitus, offering hope for more lasting improvements. Additionally, the use of music makes the treatment engaging and personalized, which could enhance patient compliance and overall effectiveness.

What evidence suggests that this sound-based treatment might be effective for tinnitus?

Research has shown that the LUCID/VIBE treatment, which participants in this trial may receive, might help manage tinnitus by using sound to mask the ringing. This treatment involves listening to music through the VIBE app, which aims to reduce the stress and irritation caused by tinnitus. Early findings suggest that this method can provide temporary relief by making the ringing sound quieter. The goal is to improve the quality of life for people with tinnitus by making it less bothersome. Overall, the LUCID/VIBE approach seems promising in helping users feel less affected by their tinnitus. ^{2 3 4 6 7}

Who Is on the Research Team?

Brandon Paul, PhD

Principal Investigator

Toronto Metropolitan University

Are You a Good Fit for This Trial?

This trial is for adults aged 50-80 with mild to severe tinnitus experienced for more than 3 months and a hearing loss of at least 30 decibels in the better ear. It's not suitable for those with pulsatile tinnitus, extreme hearing loss (>80 dB), or significant hearing differences between ears.

Inclusion Criteria

You have a score between 18 and 76 on the Tinnitus Handicap Index, which means you have mild to severe difficulty with tinnitus.

You have a hearing loss of 30 decibels or more in your better ear across certain frequencies.

You have been experiencing constant ringing in your ears for more than 3 months.

Exclusion Criteria

Your hearing loss is greater than 80 decibels when measured across both ears.

People who are under 50 or over 80 years old.

You have tinnitus that beats in rhythm with your pulse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants use the VIBE app for 24 minutes daily for 4 weeks, experiencing both the LUCID music and white noise conditions in a cross-over design

4 weeks

Follow-up

Participants are monitored for changes in tinnitus severity and quality of life using questionnaires administered up to two weeks post-intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LUCID/VIBE

Trial Overview The study tests a new sound-based treatment using an app called VIBE, comparing music (LUCID Condition) and white noise (Noise Condition) to manage tinnitus distress. Participants will use the app daily for four weeks, experiencing both treatments in a cross-over design.

How Is the Trial Designed?

Group I: LUCID Music Experimental Treatment 1 Intervention

Participants listened to music chosen from the VIBE app with theta auditory beat stimulation for 24 minutes

Group II: White Noise Placebo Group 1 Intervention

Participants listened to white noise for 24 minutes

Who Is Running the Clinical Trial?

Toronto Metropolitan University

Lead Sponsor

Trials

95

Recruited

19,300+

Lucid, Inc.

Industry Sponsor

Trials

5

Recruited

700+

Sonova Canada Inc.

Industry Sponsor

Trials

6

Recruited

150+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06083519

Assessment of a Novel Sound-based Treatment for ... The current LUCID approach utilizes the VIBE app to help provide a mask for tinnitus, manage the distress related to tinnitus, and potentially dampen stress ...

2. ctv.veeva.com ctv.veeva.com/study/assessment-of-a-novel-sound-based-treatment-for-managing-distress-related-to-tinnitus

Assessment of a Novel Sound-based Treatment for Managing ... The current LUCID approach utilizes the VIBE app to help provide a mask for tinnitus, manage the distress related to tinnitus, and potentially ...

3. withpower.com withpower.com/trial/sound-based-treatment-for-tinnitus-dd58e

Sound-based Treatment for Tinnitus This N/A medical study run by Toronto Metropolitan University is evaluating whether LUCID/VIBE will have tolerable side effects & efficacy for patients with ...

4. lucidtherapeutics.com lucidtherapeutics.com/digital-therapeutics

Digital Therapeutics Results from our adult acute anxiety study demonstrate the potential of LUCID's technology as part of an anxiety treatment program. A single 24-minute listening ...

5. dev-multi-sponsor-trials.xogene.com dev-multi-sponsor-trials.xogene.com/trials/6083519

TinnitusProject_TMU - GoodDay - Xogene 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06083519

Assessment of a Novel Sound-based Treatment for ... The current LUCID approach utilizes the VIBE app to help provide a mask for tinnitus, manage the distress related to tinnitus, and potentially dampen stress ...

7. withpower.com withpower.com/clinical-trials/for-tinnitus

Top Tinnitus Clinical Trials | Power Power is an online platform that helps thousands of Tinnitus patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical ...