Actively Recruiting
Effects of Immersive Virtual Reality Mindfulness Application on Quality of Life, Anxiety and Depression Symptoms in Children With Severe Tinnitus and Misophonia - A Pilot Study
Led by University of Colorado, Denver · Updated on 2025-04-16
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Children experiencing bothersome tinnitus and misophonia often have higher levels of anxiety and depression. Cognitive behavioral therapy (CBT) is the common treatment for these conditions but is costly and not widely available for children. Immersive virtual reality (IVR) has shown promise as a substitute for CBT in adults with mental health issues, but there is limited evidence for its effect in children. This study aims to explore if IVR can reduce anxiety and depression symptoms in children with tinnitus and misophonia. Participants will be randomly assigned in a 2:1 ratio to either receive active IVR exposure using the Aurora Mindfulness app or a placebo exposure with a sham app, both delivered via a Meta Quest 2 headset. The active group will undergo 4 weeks of 10-minute IVR sessions, 5 days per week. The placebo group will have 2 weeks of the sham exposure with the same session frequency. Assessments will be done at baseline, 2 weeks, and 4 weeks using five validated tools measuring tinnitus, misophonia severity, quality of life, anxiety, and mood. Children will be monitored through these assessments to track changes in their symptoms over time. The primary outcome is the difference in scores on these instruments from before treatment to 2 and 4 weeks after starting. Secondary outcomes include surveys on satisfaction, feasibility, and acceptability of the intervention. The total participation time varies by group, with the experimental group being evaluated for dose response between 2 and 4 weeks.
CONDITIONS
Brief Title
Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children between the ages of 10 to 18 years
- All genders and ethnicities
- Patients who meet criteria for "severe" symptoms of tinnitus and misophonia as scored by TIF and A-MISO-S
You will not qualify if you...
- Severe developmental delay preventing understanding of verbal instructions for VR application or sham exposure
- Severe visual impairment (refractive disorders are acceptable)
- Patients with unilateral or bilateral hearing loss of any type
- History of seizure disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 weeks
Participants receive immersive virtual reality exposure using the Aurora Mindfulness app or a sham app to help reduce anxiety and depression symptoms related to tinnitus and misophonia.
Baseline visit, 1 visit at 2 weeks, and 1 visit at 4 weeks
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80218
Actively Recruiting
Research Team
K
Kenny H Chan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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