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NCT06508060

Bimodal Stimulation Using Auditory and Vibrotactile Stimuli for the Mitigation of Tinnitus

Sponsor: Neosensory

View on ClinicalTrials.gov

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. 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? 2. 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: 1. Use the bimodal stimulation device for 10 minutes every day for a period of 8 weeks 2. Have one-on-one calls with the research team at the beginning and end of the study 3. Complete baseline and final tinnitus functional index assessments to track progress as a result of the intervention.

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-08

Completion Date

2024-11

Last Updated

2024-07-18

Healthy Volunteers

Conditions

Tinnitus

Interventions

DEVICE

Neosensory Wristband

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.

OTHER

Tones only

Tones will be played through an app

Inclusion Criteria: * 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 Criteria: * 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.