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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Tinnitus; Misophonia
• Intervention / Treatment: Other: Aurora Mindfulness app versus sham

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenny H Chan, MD; Phone Number: 720-777-8502; Email: kenny.chan@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80218
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Kenny H Chan, MD; Phone Number: 720-777-8502; Email: kenny.chan@childrenscolorado.org
      • Principal Investigator: Kenny H Chan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Aurora 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.
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.	Other: Aurora 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Functional Index (TFI)	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.	2 weeks
Amsterdam Misophonia Scale (A-MIS-S)	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.	2 weeks
Pediatric Quality of Life PedQL)	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.	2 weeks
Screen for Child Anxiety Related Emotional Disorders (SCARED)	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.	2 weeks
Short Mood and Feelings Questionnaire (SMFQ)	SMFQ measures depressive symptoms in children with a range of 0-26. The higher the score, the more depressive symptoms a child has.	2 weeks
Tinnitus Functional Index (TFI)	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.	4 weeka
Amsterdam Misophonia Scale (A-MIS-S)	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.	4 weeks
Pediatric Quality of Life PedQL)	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.	4 weeks
Screen for Child Anxiety Related Emotional Disorders (SCARED)	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.	4 weeks
Short Mood and Feelings Questionnaire (SMFQ)	SMFQ measures depressive symptoms in children with a range of 0-26. The higher the score, the more depressive symptoms a child has.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction, acceptability and feasibility survey	The survey is in a 5-point Likert scale format with a range of very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.	2 weeks
Satisfaction, acceptability and feasibility survey	The survey is in a 5-point Likert scale format with a range of very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.	4 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 24-0389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No