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1 Tinnitus Alleviation Via Sensory Substitution

NCT02570048 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2015-10-07

No results posted yet for this study

Summary

This is 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, 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

Interventions

DEVICE

Mutebutton intervention

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 'lollypop' sensor that sits on the anterior section (tip) of the tongue.

Sponsors & Collaborators

  • MuteButton

    lead INDUSTRY

Principal Investigators

  • Caroline Hamilton · MuteButton

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02570048 on ClinicalTrials.gov