Virtual Reality Mindfulness for Tinnitus and Misophonia

Overseen By Kenny H Chan, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Severe developmental delay, Visual impairment, Hearing loss, Seizure disorder

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Aurora Mindfulness app in virtual reality (VR) can reduce anxiety and depression in children with bothersome tinnitus (ringing in the ears) and misophonia (sensitivity to certain sounds). The study compares real VR sessions to a placebo (fake treatment) to assess the app's effectiveness. Children aged 10 to 18 with severe symptoms of either condition may be suitable participants. They will use the VR app for short sessions over a few weeks, and researchers will monitor changes in their quality of life and mood. As an unphased trial, this study provides a unique opportunity to explore innovative treatments and contribute to advancing care for children with these conditions.

Will I have to stop taking my current medications?

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

What prior data suggests that this virtual reality application is safe for children with tinnitus and misophonia?

Research has shown that mindfulness-based programs, such as the Aurora Mindfulness app, can help reduce stress in people with tinnitus. This suggests that the app might be user-friendly for them. Additionally, the app includes virtual reality therapy, which has shown promise in treating mental health issues without major side effects. Most participants have reported positive experiences with similar programs. Although limited data exists on its safety for children, virtual reality use in adults has been encouraging, with few negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for tinnitus and misophonia focus on sound therapy, cognitive behavioral therapy, or medication to alleviate symptoms. However, the Aurora Mindfulness app offers a novel approach by using virtual reality to immerse users in a calming environment, potentially enhancing mindfulness and relaxation. This innovative delivery method is exciting because it combines virtual reality technology with mindfulness exercises, offering a unique, engaging experience that may improve symptoms in a way traditional methods do not. Researchers are eager to see if this immersive technique can provide quicker or more effective relief than current options.

What evidence suggests that the Aurora Mindfulness app is effective for reducing anxiety and depression in children with tinnitus and misophonia?

Research has shown that virtual reality mindfulness tools, such as the Aurora Mindfulness app, can reduce distress in people with tinnitus. In some studies, users of similar mindfulness apps reported that their tinnitus seemed quieter and less bothersome. In this trial, participants in the experimental arm will use the Aurora Mindfulness app, while those in the placebo arm will use a sham version. Virtual reality therapy has also proven effective for managing anxiety and depression in adults, common issues for those with tinnitus and misophonia. This suggests the app might improve these symptoms in children as well. However, limited data exists on children, so the app's effectiveness for them is still under study. ^{1 2 6 7 8}

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.

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?

Group I: Experimental Experimental Treatment 1 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: Placebo Placebo Group 1 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.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality or computerised mindfulness meditation for improving mood? Preliminary efficacy from a pilot randomised trial. Poetar, CR., Bradley, N., Voinescu, A.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06493825

Mindfulness Application Effects on Mental Health ... 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 ...

2. withpower.com withpower.com/trial/virtual-reality-mindfulness-for-tinnitus-and-misophonia-e104a

Virtual Reality Mindfulness 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10487111/

The Effectiveness of a Smartphone Application for Tinnitus ... Results: A significant reduction in subjective tinnitus loudness and annoyance and subjective stress level was observed. The Tinnitus Handicap ...

4. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2022_AJA-21-00170

Evaluating the Efficacy of a Smartphone App for Tinnitus ... Across a range of tinnitus questionnaires, most participants showed either no change or decrease in tinnitus handicap. Resting-state and task-based ...

5. journals.plos.org journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000183

Pilot study of a smartphone-based tinnitus therapy using ... The app was used regularly by the patients (sound therapy: 32% of days, structured counseling: 72% of days; tinnitus assessment: 79% of days). Tinnitus handicap ...

6. reporter.nih.gov reporter.nih.gov/search/Nh1tLw2HPEyPP6IZZnwlzw/project-details/11094928

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. mdpi.com mdpi.com/2039-7283/14/4/130

Individuals with Tinnitus Report More Positive Experiences ... Our findings suggest that more participants reported positive experiences following the intervention, which align with previous research ...

8. researchgate.net researchgate.net/publication/355101571_Internet-based_audiologist-guided_cognitive_behavioral_therapy_for_tinnitus_in_the_United_States_A_randomized_controlled_trial_Preprint

Internet-based audiologist-guided cognitive behavioral ... Results: Internet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; ...