Virtual Reality Mindfulness for Tinnitus and Misophonia
What You Need to Know Before You Apply
What is the purpose of this trial?
Children with "bothersome" tinnitus and misophonia have elevated anxiety and depression symptoms. The mainstay therapy for adults and children with these disorders is cognitive behavioral therapy (CBT). CBT resources are expensive and scarce for the pediatric population. Immersive virtual reality (IVR) has been shown in the adult population to be a proxy for CBT for several mental health disorders. There is sufficient published evidence that IVR is useful in treating adults with anxiety and depression disorders. However, the evidence in children in treating either anxiety and depression symptoms or disorder is scant. Our group views IVR application as a promising medical device to decrease anxiety and depression scores in children with tinnitus and misophonia disorders.This is a randomized placebo control (single-blinded to the study subjects) study in which there will be a 2:1 ratio between the experimental and placebo subjects, receiving either active IVR or placebo exposure. A total of 30 subjects with 20 experimental (10 tinnitus, 10 misophonia subjects) and 10 placebo (5 tinnitus and 5 misophonia subjects) will enroll in this randomized clinical trial. Assessment of change of quality of life, anxiety and depression symptoms will be based on 5 validated instruments.The 5 validated instruments are: Tinnitus Functional Index (TFI), Amsterdam Misophonia Scale (A-MIS-S), Pediatric Quality of Life PEDQL), Screen for Child Anxiety Related Emotional Disorders (SCARED) and Short Mood and Feelings Questionnaire (SMFQ).
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is Virtual Reality Mindfulness safe for humans?
Research on Virtual Reality Mindfulness, including studies on mindfulness experts and other conditions like chronic migraine and binge eating, suggests it is generally safe for humans. Participants reported improvements in mood and reductions in negative emotions, with high acceptance of VR as a mindfulness tool, and no significant safety concerns were noted.12345
How is the Aurora Mindfulness app treatment different from other treatments for tinnitus and misophonia?
The Aurora Mindfulness app uses virtual reality (VR) to create immersive 3D environments combined with mindfulness techniques, offering a unique approach compared to traditional therapies like Cognitive Behaviour Therapy (CBT) or standard mindfulness practices. This novel method aims to engage users more deeply and may provide a more effective way to reduce distress associated with tinnitus and misophonia.678910
What data supports the effectiveness of the treatment Aurora Mindfulness app for tinnitus and misophonia?
Research shows that mindfulness-based interventions, like the Aurora Mindfulness app, can reduce distress in people with tinnitus. Virtual reality therapy, which is part of the Aurora app, has also been shown to improve symptoms in tinnitus patients by creating immersive environments that help manage the condition.6891112
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive immersive virtual reality exposure using the Aurora Mindfulness app or sham app for 2 to 4 weeks
Follow-up
Participants are monitored for changes in quality of life, anxiety, and depression symptoms using validated instruments
What Are the Treatments Tested in This Trial?
Interventions
- Aurora Mindfulness app
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor