Mindfulness App for Tinnitus and Misophonia in Children

This study is looking at how a mindfulness app called Aurora Mindfulness might help children aged 10 to 18 who have severe tinnitus (ringing in the ears) and misophonia (strong negative reactions to certain sounds). Many children with these conditions also experience anxiety and depression. The study will compare the Aurora Mindfulness app, which uses immersive virtual reality, to a sham (placebo) version that uses non-immersive virtual reality. Researchers will measure changes in how much tinnitus and misophonia affect daily life, as well as overall quality of life, after two weeks. The goal is to see if this app can be a helpful and more accessible way to manage these symptoms, especially since traditional therapy can be hard to find for children.

Study design
This is an interventional study planning to enroll 30 participants. It is a randomized, single-blinded study where some participants will receive the active Aurora Mindfulness app and others will receive a sham version.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' symptoms and quality of life will be measured at 2 weeks after starting the intervention.

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NCT06493825

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

Recruiting
NAAges 10–18InterventionalTreatment
University of Colorado, Denver
~30 participants
Updated 2025-04-16 on ClinicalTrials.gov
What's tested:Aurora Mindfulness app versus sham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tinnitus Functional Index (TFI)
Measured over 2 weeks
+9 more outcomes measured
Tinnitus
Misophonia
1 sites across 1 states
Colorado1

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Eligibility criteria

Inclusion

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

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
  • Tinnitus Functional Index (TFI)2 weeks

    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.

  • Amsterdam Misophonia Scale (A-MIS-S)2 weeks

    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.

  • Pediatric Quality of Life PedQL)2 weeks

    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.

  • Screen for Child Anxiety Related Emotional Disorders (SCARED)2 weeks

    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.

  • Short Mood and Feelings Questionnaire (SMFQ)2 weeks

    SMFQ measures depressive symptoms in children with a range of 0-26. The higher the score, the more depressive symptoms a child has.

  • Tinnitus Functional Index (TFI)4 weeka

    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.

  • Amsterdam Misophonia Scale (A-MIS-S)4 weeks

    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.

  • Pediatric Quality of Life PedQL)4 weeks

    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.

  • Screen for Child Anxiety Related Emotional Disorders (SCARED)4 weeks

    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.

  • Short Mood and Feelings Questionnaire (SMFQ)4 weeks

    SMFQ measures depressive symptoms in children with a range of 0-26. The higher the score, the more depressive symptoms a child has.