Recruiting

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

ClinicalTrials.gov IDNCT06493825

PhaseNA

Enrollment30

SponsorUniversity of Colorado, Denver

Age10 Years – 18 Years

SexALL

I'm interested View official listing

Conditions studied

Tinnitus, Misophonia

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 Short Mood and Feelings Questionnaire (SMFQ).

Interventions

Other: Aurora Mindfulness app versus sham — It would either immersive virtual reality exposure for the experimental group or non-immersive virtual reality exposure for the placebo group.

Primary outcomes

Tinnitus Functional Index (TFI) (2 weeks)
Amsterdam Misophonia Scale (A-MIS-S) (2 weeks)
Pediatric Quality of Life PedQL) (2 weeks)
Screen for Child Anxiety Related Emotional Disorders (SCARED) (2 weeks)
Short Mood and Feelings Questionnaire (SMFQ) (2 weeks)
Tinnitus Functional Index (TFI) (4 weeka)
Amsterdam Misophonia Scale (A-MIS-S) (4 weeks)
Pediatric Quality of Life PedQL) (4 weeks)

Eligibility information

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

Study locations

Children's Hospital Colorado, Aurora, Colorado 80218 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.