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Study identifier: NCT06493825 Synced from ClinicalTrials.gov · July 29, 2026
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Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia

Condition: Tinnitus · Misophonia  ·  Sponsor: University of Colorado, Denver

PhaseNA
Planned participants30
Who can joinAll sexes, 10 Years to 18 Years
Healthy volunteersYes

About this study

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 Sh…

This description comes directly from the study's public registry record.

Talk to the study team

Kenny H Chan, MD  ·  720-777-8502  ·  kenny.chan@childrenscolorado.org

Always discuss trial participation with your own doctor first.

Locations (1)

Children's Hospital ColoradoAurora, Colorado, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06493825