TinnitusNCT02426671
Tinnitus Alleviation Via Sensory Stimulation
A study testing MuteButton sensory stimulation device in people with Tinnitus, run by National University of Ireland, Maynooth.
Trial 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. 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 sensory stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Oct 2012
- Phase
- Interventional
- 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
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.
About this study
Official title: Tinnitus Alleviation Via Sensory Stimulation (Modulation of Tinnitus Through Simultaneous Auditory and Transcutaneous Tactile Stimulation of the Tongue)
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).
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. 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.
- Conditions
- Tinnitus
- Being tested
- MuteButton sensory stimulation device
- Keywords
- neuromodulation, Minimum Masking Level
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MuteButton sensory stimulation deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MuteButton sensory stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI)
Face to face assessment with qualified audiologists every 2 weeks
Measured: Change in THI from baseline to 12 weeks
Secondary outcomes (3)
Visual Analogue Scale (VAS)
Face to face assessment with qualified audiologists every 2 weeks
Measured: Change in VAS from baseline to 12 weeks
Tinnitus Loudness Matching (TLM)
Face to face assessment with qualified audiologists every 2 weeks
Measured: Change in TLM from baseline to 12 weeks
Minimum Masking Level (MML)
Face to face assessment with qualified audiologists every 2 weeks
Measured: Change in MML from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionOct 2012
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Maynooth
- Sponsor type
- University, hospital or other
- Collaborators
- Hermitage clinic, Lucan, Ireland
- Responsible party
- Principal investigator, Prof. Hubert Lim, National University of Ireland, Maynooth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426671
- Sponsor's protocol ID
- Pearlmutter1
- Status last verified
- Jun 2022
- First submitted
- 20 Apr 2015
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinnitus Alleviation Via Sensory Stimulation (Modulation of Tinnitus Through Simultaneous Auditory and Transcutaneous Tactile Stimulation of the Tongue)
- ClinicalTrials.gov ID
- NCT02426671
- Acronym / sponsor ID
- Pearlmutter1
- Conditions
- Tinnitus
- Keywords
- neuromodulation, Minimum Masking Level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National University of Ireland, MaynoothUniversity, hospital or other
- Collaborators
- Hermitage clinic, Lucan, Ireland
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MuteButton sensory stimulation device | Experimental | Device: MuteButton sensory stimulation deviceParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 sensory stimulation deviceParticipants 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. | Device | MuteButton sensory stimulation device |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: Change in THI from baseline to 12 weeks
Face to face assessment with qualified audiologists every 2 weeks
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Change in VAS from baseline to 12 weeks
Tinnitus Loudness Matching (TLM)
Time frame: Change in TLM from baseline to 12 weeks
Minimum Masking Level (MML)
Time frame: Change in MML from baseline to 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 8 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MuteButton sensory stimulation device in people with Tinnitus, run by National University of Ireland, Maynooth.
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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Tinnitus Handicap Inventory (THI) (time frame: Change in THI from baseline to 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 8 Jun 2022.