Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the effectiveness of a sound-based passive treatment for reducing stress and annoyance induced by tinnitus, and how this therapy may improve tinnitus sufferers' quality of life. The main questions it aims to answer are: • [question 1: to assess the efficacy of the LUCID/VIBE in managing the tinnitus handicap (measured by the reducing of the annoyance/stress response to tinnitus) contributing to the improvement of the quality of life of people living with tinnitus] and • [question 2: assess the efficacy of LUCID/VIBE in providing temporary relief through masking, such that it results in a reduction of the perceived loudness of tinnitus]. Participants will [use the VIBE app for 24 minutes a day for a period of 4 weeks. There will be two conditions, a Noise condition (the control condition in which the investigator will administer white noise) and the VIBE condition (the treatment condition). One approach involves broad-band masking with noise (Noise Condition), while the other uses music (LUCID Condition). Implementation of the noise condition will mirror the LUCID condition in terms of ease of access, look, feel, so that one condition does not look less professional than the other. Both conditions will be administered through the same app, and only the sound conditions will differ (white noise vs. LUCID music). All participants will be exposed to both the treatment and control conditions with the order of conditions counter-balanced (i.e., a cross-over design).

Detailed Description
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The current LUCID approach utilizes the VIBE app to help provide a mask for tinnitus, manage the distress related to tinnitus, and potentially dampen stress reactivity when used regularly due to the increase in parasympathetic activity. Previous findings have demonstrated that chronic tinnitus patients have elevated stress reactivity. There has also been evidence to suggest that regular music therapy interventions may enhance parasympathetic activity in the autonomic nervous system. In the past, LUCID has advanced approaches in Artificial Intelligence technology, psychology, and neuroscience to explore the potential of music to improve health and well-being. Their work to date has focused on mental health indications related to stress and anxiety. This current study differs from their previous projects because of its exploration of tinnitus rather than stress and anxiety. Their customer-facing developments have been focused on an application programming interface that has been integrated by digital-health partners and a consumer-facing app (VIBE) that has been used to support research and development. The VIBE app (LUCID) incorporates theta-band (4 Hz) auditory beat stimulation and an auditory music recommendation system. The additive effect of these elements in the treatment of acute anxiety in individuals living with moderate trait anxiety was recently demonstrated in a randomized clinical trial. The automated music recommendation system developed by LUCID employs the iso principle along with affective classification and reinforcement learning to cultivate affect-driven personalized music sequences. The iso principal is a methodology used in music therapy to achieve mood induction that involves matching musical stimuli to a patient's current mood and gradually changing the music in the direction of their desired mood state. The iso principle has been indicated in prior research to be more effective than other musical sequences at reducing tension. The system requires that a user input their current mood using the arousal and valence dimensions of the Russell Circumplex Model. Based on this input as well as the target emotional state of calm, the machine learning algorithm within the application predicts the optimal sequence of tracks to produce mood induction in the listener from their current emotional state to the target state. This machine learning algorithm uses reinforcement learning techniques and is trained on real-world data correlating the quantitative features of musical excerpts and sequences alongside the emotional responses induced by them in listeners. For this study. there will be two groups with 25 participants per group. For the control condition, a white-noise treatment for the noise condition will be administered. The researchers will be using an open-label randomized controlled trial study where the participants are told that the researchers are attempting to assess the effectiveness of two common interventions for tinnitus. One approach involves broad-band masking with noise (Noise Condition), while the other uses music (LUCID Condition). Implementation of the noise condition will mirror the LUCID condition in terms of ease of access, look, feel, so that one condition does not look less professional than the other. Both conditions will be administered through the same app, and only the sound conditions will differ (white noise vs. LUCID music). All participants will be exposed to both the treatment and control conditions with the order of conditions counter-balanced (i.e., a cross-over design). The LUCID treatment will be compared to the active control across 50 people. The participant is expected to engage in daily use of VIBE app at a specified time (e.g., for 24 minutes daily) and as needed to help mask symptoms of tinnitus. To minimize variability in dosage across groups, the investigators will impose daily limits and minimum adherence standards. Participants will be permitted to use the app for a maximum of 48 minutes per day (i.e., 200% of recommended dosage). Participants who use the app greater than 60 minutes (250% of recommended dosage) or less than 12 minutes per day on average (50% of recommended dosage) or who use the app on less than 75% of the trial days will be considered non-adherent and will be removed from the final sample subjected to analyses. These types of adherence boundaries are typical for decentralized clinical trials involving digital therapeutics. The VIBE app will be deployed on the participant's smartphone, and they will be instructed to use their own headphones (i.e., there is no standardization of the playback system). The app has built-in features which allow us to assess adherence to treatment. Participants in the study will experience each intervention condition for a period of 4 weeks. It is encouraged that the participants stop the study if they believe the sound therapy is exacerbating their tinnitus, their reaction to tinnitus, or negatively affecting their hearing ability.

Official Title
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Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus

Conditions
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Tinnitus

Intervention / Treatment
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* Behavioral: White Noise
* Behavioral: Music and Auditory Beat Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pure-Tone Average hearing loss (500, 1000, 2000, 4000) of 30 decibels hearing loss or greater in the better ear. Tinnitus Handicap Index scores of 18 to 76 (mild to severe handicap). Self-report of chronic, non-intermittent tinnitus experienced > 3 months Exclusion Criteria: Adults younger than 50 years old, or adults older than 80 years old. Pulsatile tinnitus (tinnitus that modulates synchronously with a participant's pulse) >20 dB HL difference in pure-tone average between ears > 80 dB HL PTA averaged across ears

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: White Noise<br>Participants listened to white noise for 24 minutes | Behavioral: White Noise<br>* This is the control condition. Listening to white noise -- participants listen to white noise for 24 minutes<br>|
| Experimental: LUCID Music<br>Participants listened to music chosen from the VIBE app with theta auditory beat stimulation for 24 minutes | Behavioral: Music and Auditory Beat Stimulation<br>* Listening to music and auditory beat stimulation. The VIBE app (LUCID) incorporates theta-band (4 Hz) auditory beat stimulation and an auditory music recommendation system. Participants will listen to this music with theta auditory beat stimulation for 24 minutes.<br>* Other names: LUCID Music;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index | The Tinnitus Functional Index is a self-report questionnaire. It is measuring the negative impact and severity of tinnitus, as well as to provide sensitive measurements to change based on treatment administration (i.e., responsiveness). This questionnaire consists of 25 questions administered in a Likert-Scale fashion ranging of a maximum value of 10 and a minimum value of 0 per question. In total, the maximum value a participant can score is 250 and the minimum is 0. A higher score (i.e., a score closer to 250), represents experiencing tinnitus at greater severity and experiencing a more negative impact from it. | The questionnaire is administered up to two weeks pre-intervention, and again up to two weeks post-intervention measure. The measurements will be compared to see if the intervention created a change. | 
| 36-item Short Form Health Survey | The 36-item Short Form Health Survey is a measurement tool used to assess subjective quality of life. A study has found this tool to be reliable and valid. | The questionnaire is administered up to two weeks pre-intervention, and again up to two weeks post-intervention measure. The measurements will be compared to see if the intervention created a change. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue System | Our visual analogue scale measures tinnitus annoyance using a continuous slider scale on a computer or touch-screen interface. The bottom of the scale (to the left) is Not annoying and the top of the scale (to the right) is Highest possible annoyance. | Up to 48 hours after each usage. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, iso principle, artificial intelligence, auditory perception, sound therapy, neuroscience, neuromodulatory intervention, auditory beat stimulation