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Behavioural Intervention

Experimental for Tinnitus

N/A
Waitlist Available
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Children between the ages of 10 to 18 years
* All genders and ethnicities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

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).

Who is the study for?
This trial is for children with severe tinnitus or misophonia who experience high levels of anxiety and depression. It's designed to test if a virtual reality app can help improve their quality of life. To join, kids must have bothersome symptoms but cannot be part of the study if they're already receiving cognitive behavioral therapy or other specific treatments.
What is being tested?
The trial is testing an Immersive Virtual Reality (IVR) Mindfulness app called Aurora against a sham (fake) version to see if it helps reduce anxiety and depression in kids with tinnitus or misophonia. Participants are randomly chosen to use either the real app or the sham, with more getting the actual treatment.
What are the potential side effects?
Since this trial involves a mindfulness application, there may not be direct side effects like those from medication. However, some participants might experience discomfort using VR such as dizziness, headache, eye strain, or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeka
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeka for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amsterdam Misophonia Scale (A-MIS-S)
Pediatric Quality of Life PedQL)
Screen for Child Anxiety Related Emotional Disorders (SCARED)
+2 more
Secondary study objectives
Satisfaction, acceptability and feasibility survey

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,784 Previous Clinical Trials
2,778,916 Total Patients Enrolled
~17 spots leftby Feb 2025
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