Tinnitus Alleviation Via Sensory Stimulation

Study Overview
=================
Brief Summary
-----------------
The investigators propose that a novel experimental device 'MuteButton' can affect the awareness of tinnitus. Sound that arrives at the ears naturally will be presented in the form of touch patterns on the tongue. By learning to associate the sounds in the ears with the sound patterns on the tongue, the investigators aim to demonstrate that the brain will learn to discriminate the real sounds from legitimate external sounds from the imaginary tinnitus sounds that are created inside the brain. Tinnitus is an audiological condition most commonly described as 'ringing in the ears' that affects an estimated 40 million people globally (American Tinnitus Association; Royal National Institute for Deaf). More accurately, tinnitus is the perception of illusory sound that has no legitimate external source and normally arises from a small number of underlying neuropathologies. There are broadly two categories of tinnitus - Somatic Tinnitus and Hearing Loss Related Tinnitus. MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The objective of the study will be to determine the impact of acoustic and tactile multi-modal neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS).

Detailed Description
-----------------
This study will be a prospective single arm pilot study. It will be conducted with approval from the Research Ethics Committee of NUI Maynooth and The Hermitage Medical Clinic Lucan in collaboration with Mutebutton Ltd, Nova UCD. This study will be conducted over a 16-week period with 60 suffering from permanent intractable tinnitus (>6 months) and with an accompanying/ co-existing high-frequency hearing-loss. Patients will be screened for a 4-week run-in period prior to commencement of treatment where baseline measures will be obtained and sampled every 2 weeks. Following this run-in period they will receive treatment for 10 weeks and will be followed up 2 weeks post-treatment. For the duration of the study they will be assessed every 2 weeks in the clinical environment. Participants will be given detailed instructions on use of the device, the device itself and in person step by step instructions on how to use it, and a detailed description of each control, indicator and connection. Participants will use the MuteButton device for minimum of 1 hour a day for a period of 10 weeks. The efficacy of the intervention will be assessed by the change in several psychoascoutic assessments assessed at each of the 6 follow up visits with the investigators at 2 week intervals. The Psychoacoustic Assessment will include: Tinnitus Matching (Pitch) - symptom severity Tinnitus Loudness Matching (TLM ) - symptom severity Minimum Masking Level (MML) - symptom severity Questionnaires to be utilised will include: Visual Analogue Scale (VAS) - symptom severity Tinnitus Handicap Inventory (THI) - symptom severity A primary endpoint at 16 weeks is to show a reduction in THI, and psychoacoustic assessment will be established. Secondary endpoint will include reduction in MML, and psychoacoustic assessment will be established.

Official Title
-----------------
Tinnitus Alleviation Via Sensory Stimulation (Modulation of Tinnitus Through Simultaneous Auditory and Transcutaneous Tactile Stimulation of the Tongue)

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: MuteButton sensory stimulation device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged <65 years Suffering from subjective intractable tinnitus Tinnitus > 6 months Tinnitus associated with an age or noise related sensory-neural hearing loss Have sound English reading, comprehension and written skills Able and willing to participate in the study for the 16 weeks duration Informed consent Exclusion Criteria: Ulceration of oral cavity or tongue, oral mucosa or significant intra oral disease - to mitigate risk of further aggravation these symptoms Meniere's Disease - due to the fluctuating hearing loss patients normally present with Hyperacusis - to avoid further aggravation of sensitivity of sound Current medical legal cases regarding tinnitus or hearing - in order to avoid any conflict of interest Undergoing any treatment for tinnitus - in order to accurately measure the independent effect of the intervention. Pacemakers - due to potential magnetic interference.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MuteButton sensory stimulation device<br>Participants will be asked to use the Mutebutton, neuro-modulation device every day for 60 minutes for 12 weeks. Use of the device involves placing a 'lollipop' type sensor on the tongue and wearing earphones. The participant will hear pink noise through the earphones and will receive neuro-stimulation through the sensor. The participant will not feel any discomfort whilst using the MuteButton device. | Device: MuteButton sensory stimulation device<br>* Participants are asked to use the MuteButton daily for 30-40 minutes. They receive 'pink noise' through headphones and transcutaneous stimulation on the tongue using a 'lollipop' sensor that sits on the anterior section (tip) of the tongue.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory (THI) | Face to face assessment with qualified audiologists every 2 weeks | Change in THI from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | Face to face assessment with qualified audiologists every 2 weeks | Change in VAS from baseline to 12 weeks | 
| Tinnitus Loudness Matching (TLM) | Face to face assessment with qualified audiologists every 2 weeks | Change in TLM from baseline to 12 weeks | 
| Minimum Masking Level (MML) | Face to face assessment with qualified audiologists every 2 weeks | Change in MML from baseline to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuromodulation, Minimum Masking Level