Effects of Immersive Virtual Reality Mindfulness Application on Quality of Life, Anxiety and Depression Symptoms in Children With Severe Tinnitus and Misophonia - A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Kenny H Chan, MD
kenny.chan@childrenscolorado.org
720-777-8502
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 30
Treatments
Experimental: Experimental
Subjects will undergo 4 weeks of immersive virtual reality exposure using the Aurora Mindfulness app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline, 2-week and 4-week measurement of symptoms using 5 validated instruments.
Sham_comparator: Placebo
Subjects will undergo 2 weeks of immersive virtual reality exposure using the Aurora Mindfulness sham app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline and 2-week measurement of symptoms using 5 validated instruments.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov