Mindfulness App for Children with Severe Tinnitus and Misophonia
Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia
Recruiting
N/AInterventional Study
TinnitusMisophonia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
10 – 18
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for children aged 10 to 18 with severe symptoms of tinnitus or misophonia. Participants will try a virtual reality program to see if it can help reduce anxiety and depression.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 10 and 18 years old
I am of any gender and ethnicity
I have been diagnosed with severe tinnitus
I have been diagnosed with severe misophonia
You may not be able to join if
I have a severe developmental delay
I have severe visual impairment
I have any type of hearing loss
I have a history of seizure disorder
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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).
Trial Locations
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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 nec…
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
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