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Behavioural Intervention

Sound-based Treatment for Tinnitus

N/A

Waitlist Available

Led By Brandon Paul, PhD

Research Sponsored by Toronto Metropolitan University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 hours after each usage.

Awards & highlights

Study Summary

This trial assesses a sound-based treatment to reduce stress & annoyance of tinnitus, & improve quality of life. Participants use a VIBE app for 24 min/day for 4 weeks, with noise & music conditions to assess efficacy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include temporary discomfort from listening to sounds, possible increase in tinnitus perception after sound exposure, or auditory fatigue due to prolonged use of headphones during the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the questionnaire is administered up to two weeks pre-intervention, and again up to two weeks post-intervention measure. the measurements will be compared to see if the intervention created a change.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the questionnaire is administered up to two weeks pre-intervention, and again up to two weeks post-intervention measure. the measurements will be compared to see if the intervention created a change.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the questionnaire is administered up to two weeks pre-intervention, and again up to two weeks post-intervention measure. the measurements will be compared to see if the intervention created a change. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

36-item Short Form Health Survey

Tinnitus Functional Index

Secondary outcome measures

Visual Analogue System

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LUCID MusicExperimental Treatment1 Intervention

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

Group II: White NoisePlacebo Group1 Intervention

Participants listened to white noise for 24 minutes

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Toronto Metropolitan UniversityLead Sponsor

83 Previous Clinical Trials

10,867 Total Patients Enrolled

Lucid, Inc.Industry Sponsor

4 Previous Clinical Trials

652 Total Patients Enrolled

Sonova Canada Inc.Industry Sponsor

5 Previous Clinical Trials

96 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this trial open to elderly participants?

"This research project is open to individuals aged 50 and older, up until 79 years old."

Answered by AI

Who has the eligibility to sign up for this experiment?

"The current medical study is enrolling 50 patients suffering from tinnitus between the ages of 50 and 79. To be considered, applicants must possess a Tinnitus Handicap Index score of 18 to 76 indicating mild to severe handicaps associated with their condition."

Answered by AI

Is this trial actively recruiting participants?

"Per the information provided by clinicaltrials.gov, this medical study is not presently recruiting patients. First posted on October 22nd 2023 and last updated on October 5th of that same year, there are no open positions within this specific trial; however, 48 other trials in progress have available slots for suitable candidates."

Answered by AI

Recent research and studies

Plos OneJournal

The Effects of Music & Auditory Beat Stimulation on Anxiety: A Randomized Clinical Trial

Mallik, Adiel, and Frank A. Russo. 2022. “The Effects of Music & Auditory Beat Stimulation on Anxiety: A Randomized Clinical Trial”. Edited by Humaira Nisar. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0259312.

Frontiers in PsychologyJournal

Auditory Driving of the Autonomic Nervous System: Listening to Theta-frequency Binaural Beats Post-exercise Increases Parasympathetic Activation and Sympathetic Withdrawal

McConnell, Patrick A., Brett Froeliger, Eric L. Garland, Jeffrey C. Ives, and Gary A. Sforzo. 2014. “Auditory Driving of the Autonomic Nervous System: Listening to Theta-frequency Binaural Beats Post-exercise Increases Parasympathetic Activation and Sympathetic Withdrawal”. Frontiers in Psychology. Frontiers Media SA. doi:10.3389/fpsyg.2014.01248.

clinicaltrials.govStudy

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

Brandon Paul 2024. "Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06083519.

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