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

NCT06493825 | Recruiting

• 1 other identifier: 24-0389
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Tinnitus; Misophonia

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Satisfaction, acceptability and feasibility survey

  2 weeks

• Satisfaction, acceptability and feasibility survey

  4 weeks

Study Arms (2)

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

Placebo

SHAM COMPARATOR

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

Interventions

Aurora Mindfulness app versus sham OTHER

It would either immersive virtual reality exposure for the experimental group or non-immersive virtual reality exposure for the placebo group.

Experimental; Placebo

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80218, United States

RECRUITING

MeSH Terms

Conditions

Tinnitus; misophonia

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kenny H Chan, MD

CONTACT

720-777-8502; kenny.chan@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: September 1, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)