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

Recruiting · NCT06493825 · Interventional (participants receive a specific treatment)

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Interventions studied

Aurora Mindfulness app versus sham

What this trial is about

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).

Who can take part

Age range

10 Years to 18 Years

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed across 1 US state.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →