TinnitusNCT02570048
1 Tinnitus Alleviation Via Sensory Substitution
An observational study of Tinnitus, run by MuteButton at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Mutebutton intervention
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tinnitus Alleviation Via Sensory Substitution (Modulation of Tinnitus Through Simultaneous Auditory and Transcutaneous Tactile Stimulation of the Tongue).
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).
Read the 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. Participants 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 the IFU (Appendix 3) along with the device and given 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 every 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 a THI, and psychoacoustic assessment will be established. Secondary endpoint will include reduction in MML, and psychoacoustic assessment will be established.
- Conditions
- Tinnitus
- Being tested
- Mutebutton intervention
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mutebutton interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mutebutton intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieve a clinically significant reduction in Tinnitus Handicap Inventory (THI) score
Measured: 12 weeks
Secondary outcomes (3)
Difference in mean Visual Analogue Scale (VAS) score from before after intervention
Measured: 12 weeks
Difference in mean Tinnitus Loudness Matching (TLM) score before and after intervention.
Measured: 12 weeks
Difference in mean Minimum Masking Level (MML) score intervention before and after intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- MuteButton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline Hamilton, Principal investigator, MuteButton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570048
- Sponsor's protocol ID
- Tinnitus pilotV1
- Status last verified
- Oct 2015
- First submitted
- 28 Sep 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinnitus Alleviation Via Sensory Substitution (Modulation of Tinnitus Through Simultaneous Auditory and Transcutaneous Tactile Stimulation of the Tongue).
- ClinicalTrials.gov ID
- NCT02570048
- Acronym / sponsor ID
- Tinnitus pilotV1
- Conditions
- Tinnitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MuteButtonIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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. Participants 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 the IFU (Appendix 3) along with the device and given 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 every 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 a THI, and psychoacoustic assessment will be established. Secondary endpoint will include reduction in MML, and psychoacoustic assessment will be established.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Mutebutton intervention | – | Device: Mutebutton interventionThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mutebutton interventionParticipants 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. | Device | Experimental: Mutebutton intervention |
Primary outcome
Number of participants who achieve a clinically significant reduction in Tinnitus Handicap Inventory (THI) score
Time frame: 12 weeks
3 secondary outcomes
Difference in mean Visual Analogue Scale (VAS) score from before after intervention
Time frame: 12 weeks
Difference in mean Tinnitus Loudness Matching (TLM) score before and after intervention.
Time frame: 12 weeks
Difference in mean Minimum Masking Level (MML) score intervention before and after intervention.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Hamilton principal investigator
MuteButton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by MuteButton at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who achieve a clinically significant reduction in Tinnitus Handicap Inventory (THI) score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.