Status:
NOT_YET_RECRUITING
Bimodal Stimulation Using Auditory and Vibrotactile Stimuli for the Mitigation of Tinnitus
Lead Sponsor:
Neosensory
Conditions:
Tinnitus
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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...
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 measur...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06508060
Start Date
August 1 2024
End Date
November 1 2024
Last Update
July 18 2024
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