Tinnitus Alleviation Via Sensory Stimulation

NCT02426671 | Completed

• 1 other identifier: Pearlmutter1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Tinnitus

Keywords

neuromodulation; Minimum Masking Level

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Inventory (THI)

  Face to face assessment with qualified audiologists every 2 weeks

  Change in THI from baseline to 12 weeks

Secondary Outcomes (3)

• Visual Analogue Scale (VAS)

  Change in VAS from baseline to 12 weeks

• Tinnitus Loudness Matching (TLM)

  Change in TLM from baseline to 12 weeks

• Minimum Masking Level (MML)

  Change in MML from baseline to 12 weeks

Study Arms (1)

MuteButton sensory stimulation device

EXPERIMENTAL

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

Interventions

MuteButton sensory stimulation device DEVICE

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.

MuteButton sensory stimulation device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Ireland, Maynooth: lead
• Hermitage clinic, Lucan, Ireland: collaborator

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Pearlmutter

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 27, 2015
• Study Start: June 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 8, 2022

Record last verified: 2022-06