1 Tinnitus Alleviation Via Sensory Substitution

NCT02570048 | Completed

• 1 other identifier: Tinnitus pilotV1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants who achieve a clinically significant reduction in Tinnitus Handicap Inventory (THI) score

  12 weeks

Secondary Outcomes (3)

• Difference in mean Visual Analogue Scale (VAS) score from before after intervention

  12 weeks

• Difference in mean Tinnitus Loudness Matching (TLM) score before and after intervention.

  12 weeks

• Difference in mean Minimum Masking Level (MML) score intervention before and after intervention.

  12 weeks

Study Arms (1)

Experimental: Mutebutton intervention

This one armed trail will recruit participants who have been diagnosed with Tinnitus for a minimum of 6 months. Participants will use the Mutebutton device in their own home for 30 minutes every day for 12 weeks. The intervention requires sitting in a quiet space with the earphones on and the tongue tip placed on their tongue.

Device: Mutebutton intervention

Interventions

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

Experimental: Mutebutton intervention

Eligibility Criteria

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

Study Population

The study population will be persons who are diagnosed as having tinitus by an audiologists that are at least 18 years of age. It is expected that the user age distribution will be skewed towards an older deomographic due to the increased prevalence of hearing loss-related tinnitus in the elderly.

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

• MuteButton: lead

Study Sites (1)

Hermitage Medical Clinic, Lucan

Dublin, Ireland

Location

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 Officials

• Caroline Hamilton

  MuteButton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 7, 2015
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

IE (1)