Effects of a Mindfulness App on Mental Health in Children with Tinnitus and Misophonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of an immersive virtual reality mindfulness application on mental health symptoms in children aged 10 to 18 with severe tinnitus and misophonia. The study employs a randomized placebo-controlled design, where participants will be assigned to either the active IVR application or a placebo exposure in a 2:1 ratio. The effectiveness of the intervention will be assessed using five validated instruments that measure quality of life, anxiety, and depression symptoms. The goal is to determine if the IVR application can serve as an effective alternative to traditional cognitive behavioral therapy, which is often inaccessible for pediatric patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DeepTMS for chronic tinnitus using different H-coils

  This study tests whether deep repetitive transcranial magnetic stimulation with different H-coils can reduce tinnitus distress in adults with chronic tinnitus, compared to placebo.

  Recruiting University of Regensburg · Regensburg, Bavaria · NCT07885176

• Non-Invasive Neurofeedback for Tinnitus Distress

  This trial tests whether real-time neurofeedback training can reduce distress from tinnitus in adults with bothersome symptoms.

  Recruiting University of Illinois at Urbana-Champaign · Urbana, Illinois · NCT07788638

• TRTL-913 in adults with tinnitus: safety and signals of benefit

  This trial tests TRTL-913 versus placebo in healthy adults and in adults with tinnitus to see if it is safe, tolerable, and potentially helpful for tinnitus patients.

  Recruiting Phase 2 Tortugas Neuroscience, Inc. · Newcastle, New South Wales and 9 other locations · NCT07777549

• Foot reflexology or ta-VNS for tinnitus in adults

  This trial tests whether foot reflexology, left-ear vagus nerve stimulation, or auricular acupressure can help reduce tinnitus symptoms in adults with tinnitus.

  Recruiting Tzu Chi University · Hualien City · NCT07711639

• Mild 8 dB hearing amplification for tinnitus in adults with normal hearing

  This test tries wearing hearing aids that add a small (8 dB) boost to see if they reduce tinnitus symptoms in adults with normal hearing.

  Recruiting Technical University of Denmark · Lyngby · NCT07489807

• How common misophonia is among high school students in Kayseri and Samsun, Turkey

  This project will use a short questionnaire to see how common and how severe misophonia is among high school students in Kayseri and Samsun, Turkey.

  Recruiting at 2 sites Ondokuz Mayıs University · Kayseri and 1 other locations · NCT07469033

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.