Misophonia, Tinnitus
Conditions
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).
Detailed description
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). The primary outcome measures are the changes ot the pre-entry and post-entry scores of the 5 validated instruments at 2 weeks post-entry. In the experimental group, dose response will be measured between the 2- and 4-week results.
Interventions
OTHERAurora 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Functional Index (TFI) | 2 weeks | TFI measures the severity of tinnitus symptoms across several domains with a score range 0 to 90. The higher the score, the more dysfunction a subject is affected by tinnitus. |
| Amsterdam Misophonia Scale (A-MIS-S) | 2 weeks | A-MIS-S measures the severity of misophonia symptoms across several domains with a score range of 0-24. The higher the score, the more dysfunction a subject is affected by misophonia. |
| Pediatric Quality of Life PedQL) | 2 weeks | PedQL measures health-related quality of life of children with a range of 0 -100. The higher the score, the worse the health-related quality of life is. |
| Screen for Child Anxiety Related Emotional Disorders (SCARED) | 2 weeks | SCARED screens for anxiety disorder in children and it ranges from 0-82. The higher the score, the higher the likelihood a child might have an anxiety disorder. |
| Short Mood and Feelings Questionnaire (SMFQ) | 2 weeks | SMFQ measures depressive symptoms in children with a range of 0-26. The higher the score, the more depressive symptoms a child has. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction, acceptability and feasibility survey | 2 weeks | The survey is in a 5-point Likert scale format with a range of very satisfied, satisfied, neutral, unsatisfied and very unsatisfied. |
Countries
United States
Contacts
Primary ContactKenny H Chan, MD
Outcome results
None listed