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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.
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.
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.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
36-item Short Form Health Survey
Tinnitus Functional Index
Secondary study objectives
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
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Who is running the clinical trial?
Toronto Metropolitan UniversityLead Sponsor
91 Previous Clinical Trials
18,956 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
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