ClinConnect ClinConnect Logo
Search / Trial NCT06493825

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.

Locations

Aurora, Colorado, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported