Tinnitus Alleviation Via Sensory Stimulation
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

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.
    

Intervention name(s): MuteButton sensory stimulation device
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neuromodulation; Minimum Masking Level