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Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia

RecruitingNAAges 10 Years - 18 YearsAllUniversity of Colorado, Denver
NCT06493825 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 b

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Severe developmental delay as not to understand verbal instructions necessary to complete the VR application/sham exposure. * Severe visual impairment (refractive disorders are acceptable) * Patients with unilateral or bilateral hearing loss of any type. * History of seizure disorder
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What it tests

  • Aurora Mindfulness app versus sham
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Where

1 site
Children's Hospital Colorado
Aurora, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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