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Behavioural Intervention

Virtual Reality Mindfulness for Tinnitus and Misophonia

N/A

Waitlist Available

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Children between the ages of 10 to 18 years

Patients who meet criteria for 'severe' symptoms of tinnitus and misophonia as scored by TIF and A-MISO-S

Must not have

Patients with unilateral or bilateral hearing loss of any type

History of seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial aims to study the effectiveness of immersive virtual reality (IVR) in reducing anxiety and depression symptoms in children with bothersome tinnitus and misophonia. These children often experience elevated levels of

Who is the study for?

This trial is for children with severe tinnitus or misophonia who experience high levels of anxiety and depression. It's designed to test if a virtual reality app can help improve their quality of life. To join, kids must have bothersome symptoms but cannot be part of the study if they're already receiving cognitive behavioral therapy or other specific treatments.

What is being tested?

The trial is testing an Immersive Virtual Reality (IVR) Mindfulness app called Aurora against a sham (fake) version to see if it helps reduce anxiety and depression in kids with tinnitus or misophonia. Participants are randomly chosen to use either the real app or the sham, with more getting the actual treatment.

What are the potential side effects?

Since this trial involves a mindfulness application, there may not be direct side effects like those from medication. However, some participants might experience discomfort using VR such as dizziness, headache, eye strain, or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 18 years old.

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I have severe tinnitus and misophonia according to TIF and A-MISO-S scores.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have hearing loss in one or both ears.

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I have a history of seizures.

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I cannot follow verbal instructions due to severe developmental delay.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Amsterdam Misophonia Scale (A-MIS-S)

Pediatric Quality of Life PedQL)

Screen for Child Anxiety Related Emotional Disorders (SCARED)

+2 more

Secondary study objectives

Satisfaction, acceptability and feasibility survey

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Subjects will undergo 4 weeks of immersive virtual reality exposure using the Aurora Mindfulness app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline, 2-week and 4-week measurement of symptoms using 5 validated instruments.

Group II: PlaceboPlacebo Group1 Intervention

Subjects will undergo 2 weeks of immersive virtual reality exposure using the Aurora Mindfulness sham app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline and 2-week measurement of symptoms using 5 validated instruments.

0 / 5Eligibility criteria met