NCT06493825 Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia
| NCT ID | NCT06493825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-09-01 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Short Mood and Feelings Questionnaire (SMFQ).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06493825 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06493825 currently recruiting?
Yes, NCT06493825 is actively recruiting participants. Contact the research team at kenny.chan@childrenscolorado.org for enrollment information.
Where is the NCT06493825 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06493825 clinical trial?
NCT06493825 is sponsored by University of Colorado, Denver. The trial plans to enroll 30 participants.