30 Participants Needed

Virtual Reality Mindfulness for Tinnitus and Misophonia

KH
Overseen ByKenny H Chan, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is Virtual Reality Mindfulness safe for humans?

Research on Virtual Reality Mindfulness, including studies on mindfulness experts and other conditions like chronic migraine and binge eating, suggests it is generally safe for humans. Participants reported improvements in mood and reductions in negative emotions, with high acceptance of VR as a mindfulness tool, and no significant safety concerns were noted.12345

How is the Aurora Mindfulness app treatment different from other treatments for tinnitus and misophonia?

The Aurora Mindfulness app uses virtual reality (VR) to create immersive 3D environments combined with mindfulness techniques, offering a unique approach compared to traditional therapies like Cognitive Behaviour Therapy (CBT) or standard mindfulness practices. This novel method aims to engage users more deeply and may provide a more effective way to reduce distress associated with tinnitus and misophonia.678910

What data supports the effectiveness of the treatment Aurora Mindfulness app for tinnitus and misophonia?

Research shows that mindfulness-based interventions, like the Aurora Mindfulness app, can reduce distress in people with tinnitus. Virtual reality therapy, which is part of the Aurora app, has also been shown to improve symptoms in tinnitus patients by creating immersive environments that help manage the condition.6891112

Are You a Good Fit for This Trial?

This trial is for children with severe tinnitus or misophonia who experience high levels of anxiety and depression. It's designed to test if a virtual reality app can help improve their quality of life. To join, kids must have bothersome symptoms but cannot be part of the study if they're already receiving cognitive behavioral therapy or other specific treatments.

Inclusion Criteria

My gender or ethnicity does not limit my participation.
I have severe tinnitus and misophonia according to TIF and A-MISO-S scores.

Exclusion Criteria

I have hearing loss in one or both ears.
I have severe vision problems, but wearing glasses or contacts is okay.
I have a history of seizures.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immersive virtual reality exposure using the Aurora Mindfulness app or sham app for 2 to 4 weeks

4 weeks
Baseline, 2-week, and 4-week measurements

Follow-up

Participants are monitored for changes in quality of life, anxiety, and depression symptoms using validated instruments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aurora Mindfulness app
Trial Overview The trial is testing an Immersive Virtual Reality (IVR) Mindfulness app called Aurora against a sham (fake) version to see if it helps reduce anxiety and depression in kids with tinnitus or misophonia. Participants are randomly chosen to use either the real app or the sham, with more getting the actual treatment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Published Research Related to This Trial

A pilot study with 44 mindfulness experts using Virtual Reality (VR) for Dialectical Behavioral Therapy (DBT®) mindfulness training showed significant improvements in state of mindfulness and reductions in negative emotions like sadness, anger, and anxiety.
Participants experienced a strong sense of presence in the VR environment and accepted it as a useful tool for mindfulness practice, suggesting that VR could enhance the accessibility and effectiveness of mindfulness training for those who struggle with traditional methods.
Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference.Navarro-Haro, MV., López-Del-Hoyo, Y., Campos, D., et al.[2023]
In a pilot study with 47 healthy participants, both immersive virtual reality (VR) mindfulness and computer-based mindfulness meditation effectively reduced negative emotions, but there were no significant differences in mood improvement between the two methods.
The study found that using VR did not cause simulator sickness, indicating that it is a safe and viable method for delivering mindfulness interventions.
Immersive virtual reality or computerised mindfulness meditation for improving mood? Preliminary efficacy from a pilot randomised trial.Poetar, CR., Bradley, N., Voinescu, A.[2023]

Citations

Auditory and visual 3D virtual reality therapy as a new treatment for chronic subjective tinnitus: Results of a randomized controlled trial. [2018]
Mindfulness-Based Cognitive Therapy as a Treatment for Chronic Tinnitus: A Randomized Controlled Trial. [2018]
The Effect of Mindfulness-Based Interventions on Tinnitus Distress. A Systematic Review. [2023]
A clinical trial of a patient-customized virtual reality intervention for tinnitus. [2022]
Mindfulness-Based Cognitive Therapy for Chronic Tinnitus: Evaluation of Benefits in a Large Sample of Patients Attending a Tinnitus Clinic. [2019]
Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. [2023]
The Utility of a Novel, Combined Biofeedback-Virtual Reality Device as Add-on Treatment for Chronic Migraine: A Randomized Pilot Study. [2023]
Using virtual reality to train inhibitory control and reduce binge eating: A proof-of-concept study. [2022]
The Role of Sense of Voice Presence and Anxiety Reduction in AVATAR Therapy. [2020]
Immersive virtual reality or computerised mindfulness meditation for improving mood? Preliminary efficacy from a pilot randomised trial. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Healing From Home: Examination of an Online Mindfulness-Based Tinnitus Stress Reduction Course During the 2020 COVID Pandemic. [2023]
Assessing mindfulness-based cognitive therapy intervention for tinnitus using behavioural measures and structural MRI: a pilot study. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security