TinnitusNCT06508060
Bimodal Stimulation Using Auditory and Vibrotactile Stimuli for the Mitigation of Tinnitus
A study testing Neosensory Wristband and Tones only in people with Tinnitus, run by Neosensory.
Trial summary
The goal of this clinical trial is to learn if a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist works to treat moderate to severe tinnitus in adults. It will also learn about the safety of the device. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Neosensory Wristband and Tones only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Nov 2024
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide and understand informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Initial Tinnitus Functional Index Score of 42 points or higher indicating mild, moderate, or severe tinnitus
- Subjective tinnitus that is described as tonal or white noise
- Age 22 and over at the time of consent
- Ability to read and understand English
- Tinnitus duration for greater than or equal to 3 months
- Able to provide an audiogram performed by a licensed audiologist within the past 12 months
Who cannot join
- Individuals who are non-English speaking
- Subjective tinnitus, where pulsatility is the dominant feature (participant reported)
- Objective tinnitus, where the tinnitus is also observed by the examiner
- Commenced usage of hearing aid within the last 90 days
- Meniere\'s disease
- Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
Show all 17Show fewer
- TMJ Disorder
- Pregnancy
- Neurological condition that may lead to seizures or loss of consciousness (e.g. epilepsy)
- Severe cognitive impairment based on MMSE (score less than 20)
- Abnormal findings following otoscopy/tympanometry that may be contributing to or causing the tinnitus as assessed by an Audiologist/ENT (participant reported)
- Initiated new prescription medications or medical treatments in the previous 3 months
- Ceased prescription medications or medical treatments in the previous 3 months
- Participant previously diagnosed with psychosis or schizophrenia
- Previous use of Neosensory Duo
- Previous involvement in a clinical investigation for tinnitus or had an experimental/surgical treatment for tinnitus
- Hearing loss of greater than 80 dB HL in any test frequency in the set {2k,3k,4k,6k,8k} Hz or greater than 40 dB HL in the set {250,500,1k} Hz either unilaterally or bilaterally. This information will be obtained from an audiogram performed by a licensed audiologist, that is provided by the candidate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial Investigating the Efficacy and Safety of a Device That Uses Bimodal Stimulation, Consisting of Auditory and Vibrotactile Stimuli, for the Mitigation of Tinnitus
The goal of this clinical trial is to learn if a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist works to treat moderate to severe tinnitus in adults. It will also learn about the safety of the device. The main questions it aims to answer are:
- Does a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist decrease the severity of tinnitus symptoms in adults with moderate to severe tinnitus?
- What medical problems do participants report when using a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist?
Read more
Researchers will compare a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist to a control condition in which only auditory tones are used, without the device, to see if the bimodal stimulation device works to treat moderate to severe tinnitus.
Participants will:
- Use the bimodal stimulation device for 10 minutes every day for a period of 8 weeks
- Have one-on-one calls with the research team at the beginning and end of the study
- Complete baseline and final tinnitus functional index assessments to track progress as a result of the intervention.
Read the detailed description
Our research hypothesis is, randomized tones coupled with a spatial spread of vibrotactile signals on the wrist to deliver bimodal stimulation will decrease the severity of tinnitus symptoms as measured by a clinically significant improvement on the Tinnitus Functional Index questionnaire (TFI). We also hypothesize this treatment will prove to be safe, with minimal or no side effects.
We will recruit adults in the United States who respond to an online advertisement that mentions a study investigating a new tinnitus treatment. A total of 200 participants will be confirmed and randomly assigned to a wristband condition or an audio-only control condition (100 participants per condition).
Each participant will complete ten minutes of treatment daily over the course of the eight-week study. The treatment will include listening to tones and, unless in the control condition, feeling corresponding vibrations on the wrist. In the control condition, participants will listen to tones without additional vibrotactile stimulation from a wristband. Participants will complete the TFI questionnaire at baseline prior to starting treatment with Duo and after 8 weeks of treatment.
- Conditions
- Tinnitus
- Being tested
- Neosensory Wristband, Tones only
- Keywords
- Biomodal stimulation, Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neosensory WristbandDevice
The Neosensory wristband consists of four vibratory motors built into the strap of the wristband (Figure 1a). The motors are linear resonant actuators (LRAs), vibrating at 175 Hz, capable of rising from 0 to 50% of their intensity within 30 ms. The motor intensity can be controlled with an eight bit resolution, meaning each motor can be controlled at 256 different intensities. At the highest intensity, each motor vibrates at 1.7 GRMS. The motors are separated from one another at a distance of 18.2 mm and 19.2 mm for the small and large wristband sizes, respectively (center-to-center distances).
The top of the wristband is a module that contains the power button, user setting buttons, a microphone, and a microcontroller. Bluetooth communication is used to create the corresponding vibrations on the wristband. While the study app plays the tones, it also sends a Bluetooth command to the wristband such that the wristband vibrates in the appropriate illusory location.
Tones onlyOther
Tones will be played through an app
| Study group | Role | What they receive |
|---|---|---|
| Tones combined with vibrotactile stimulation | Experimental | The experimental group will receive treatment consisting of tones combined with vibrotactile stimulation delivered from a haptic wristband. Receives: Device: Neosensory Wristband |
| Tones alone | Other | The control group will receive treatment consisting of tones alone, without the addition of vibrotactile stimulation from a wristband. Receives: Other: Tones only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Functional Index
The Tinnitus Functional Index (TFI) is a self-report questionnaire that measures the severity and negative effects of tinnitus. It's used to assess how tinnitus affects a person in multiple domains, and can also be used to measure changes in tinnitus related to treatment.
Measured: From the first day of treatment to the final day of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neosensory
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508060
- Sponsor's protocol ID
- 2016/01/7
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We have no reason to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating the Efficacy and Safety of a Device That Uses Bimodal Stimulation, Consisting of Auditory and Vibrotactile Stimuli, for the Mitigation of Tinnitus
- ClinicalTrials.gov ID
- NCT06508060
- Acronym / sponsor ID
- 2016/01/7
- Conditions
- Tinnitus
- Keywords
- Biomodal stimulation, Tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NeosensoryIndustry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Jul 2024 (actual)
- 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 goal of this clinical trial is to learn if a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist works to treat moderate to severe tinnitus in adults. It will also learn about the safety of the device. The main questions it aims to answer are:
- Does a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist decrease the severity of tinnitus symptoms in adults with moderate to severe tinnitus?
- What medical problems do participants report when using a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist?
Researchers will compare a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist to a control condition in which only auditory tones are used, without the device, to see if the bimodal stimulation device works to treat moderate to severe tinnitus.
Participants will:
- Use the bimodal stimulation device for 10 minutes every day for a period of 8 weeks
- Have one-on-one calls with the research team at the beginning and end of the study
- Complete baseline and final tinnitus functional index assessments to track progress as a result of the intervention.
Detailed description
Our research hypothesis is, randomized tones coupled with a spatial spread of vibrotactile signals on the wrist to deliver bimodal stimulation will decrease the severity of tinnitus symptoms as measured by a clinically significant improvement on the Tinnitus Functional Index questionnaire (TFI). We also hypothesize this treatment will prove to be safe, with minimal or no side effects.
We will recruit adults in the United States who respond to an online advertisement that mentions a study investigating a new tinnitus treatment. A total of 200 participants will be confirmed and randomly assigned to a wristband condition or an audio-only control condition (100 participants per condition).
Each participant will complete ten minutes of treatment daily over the course of the eight-week study. The treatment will include listening to tones and, unless in the control condition, feeling corresponding vibrations on the wrist. In the control condition, participants will listen to tones without additional vibrotactile stimulation from a wristband. Participants will complete the TFI questionnaire at baseline prior to starting treatment with Duo and after 8 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tones combined with vibrotactile stimulation | Experimental | Device: Neosensory WristbandThe experimental group will receive treatment consisting of tones combined with vibrotactile stimulation delivered from a haptic wristband. |
| Tones alone | Other | Other: Tones onlyThe control group will receive treatment consisting of tones alone, without the addition of vibrotactile stimulation from a wristband. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide and understand informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Initial Tinnitus Functional Index Score of 42 points or higher indicating mild, moderate, or severe tinnitus
- Subjective tinnitus that is described as tonal or white noise
- Age 22 and over at the time of consent
Key exclusion criteria (17 listed)
- Individuals who are non-English speaking
- Subjective tinnitus, where pulsatility is the dominant feature (participant reported)
- Objective tinnitus, where the tinnitus is also observed by the examiner
- Commenced usage of hearing aid within the last 90 days
- Meniere\'s disease
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 |
|---|---|---|
| Neosensory WristbandThe Neosensory wristband consists of four vibratory motors built into the strap of the wristband (Figure 1a). The motors are linear resonant actuators (LRAs), vibrating at 175 Hz, capable of rising from 0 to 50% of their intensity within 30 ms. The motor intensity can be controlled with an eight bit resolution, meaning each motor can be controlled at 256 different intensities. At the highest intensity, each motor vibrates at 1.7 GRMS. The motors are separated from one another at a distance of 18.2 mm and 19.2 mm for the small and large wristband sizes, respectively (center-to-center distances). The top of the wristband is a module that contains the power button, user setting buttons, a microphone, and a microcontroller. Bluetooth communication is used to create the corresponding vibrations on the wristband. While the study app plays the tones, it also sends a Bluetooth command to the wristband such that the wristband vibrates in the appropriate illusory location. | Device | Tones combined with vibrotactile stimulation |
| Tones onlyTones will be played through an app | Other | Tones alone |
Primary outcome
Tinnitus Functional Index
Time frame: From the first day of treatment to the final day of treatment at 8 weeks
The Tinnitus Functional Index (TFI) is a self-report questionnaire that measures the severity and negative effects of tinnitus. It's used to assess how tinnitus affects a person in multiple domains, and can also be used to measure changes in tinnitus related to treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No. We have no reason to share IPD with other researchers
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Neosensory Wristband and Tones only in people with Tinnitus, run by Neosensory.
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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Izzy Kohler, DPT (585-943-0580, kohler@neosensory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Functional Index (time frame: From the first day of treatment to the final day of treatment at 8 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 18 Jul 2024.