Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia
Launched by UNIVERSITY OF COLORADO, DENVER · Jul 2, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a special virtual reality (VR) application can help children aged 10 to 18 years who have severe tinnitus (ringing in the ears) and misophonia (a strong dislike of specific sounds). These children often experience increased anxiety and depression, and while cognitive behavioral therapy (CBT) is a common treatment, it can be hard to access. This trial will compare the effects of the active VR treatment to a placebo (a non-active version) to see if the VR can improve the children's symptoms and quality of life.
To participate in the study, children must be between 10 and 18 years old and have been diagnosed with severe tinnitus or misophonia. They will undergo assessments using five different questionnaires to measure changes in their mental health and well-being. The trial is currently recruiting participants, and it’s important to note that children with certain conditions, like severe developmental delays or hearing loss, will not be eligible to join. Overall, this study aims to explore an innovative treatment option for young people struggling with these challenging conditions.
Gender
ALL
Eligibility criteria
- 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
About University Of Colorado, Denver
The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aurora, Colorado, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported