Recruiting

Mindfulness Application

Sponsor:

University of Colorado, Denver

Code:

NCT06493825

Conditions

Tinnitus

Misophonia

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Accepted

Interventions

Aurora Mindfulness app versus sham

Study Details

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

Study ID

NCT06493825

Start date

Sep 1, 2024

Status verified date

Apr, 2025

Completion date

Dec 15, 2025

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Tinnitus Functional Index (TFI) [ Time Frame: 2 weeks ]
  • Amsterdam Misophonia Scale (A-MIS-S) [ Time Frame: 2 weeks ]
  • Pediatric Quality of Life PedQL) [ Time Frame: 2 weeks ]
  • Screen for Child Anxiety Related Emotional Disorders (SCARED) [ Time Frame: 2 weeks ]
  • Short Mood and Feelings Questionnaire (SMFQ) [ Time Frame: 2 weeks ]
  • Tinnitus Functional Index (TFI) [ Time Frame: 4 weeka ]
  • Amsterdam Misophonia Scale (A-MIS-S) [ Time Frame: 4 weeks ]
  • Pediatric Quality of Life PedQL) [ Time Frame: 4 weeks ]
  • Screen for Child Anxiety Related Emotional Disorders (SCARED) [ Time Frame: 4 weeks ]
  • Short Mood and Feelings Questionnaire (SMFQ) [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Kenny H Chan, MD

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

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80218

Contacts

Kenny H Chan, MD

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

Principal Investigator:

Kenny H Chan, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 16, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-04-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.