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

Launched by NEOSENSORY · Jul 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device that combines sound and gentle vibrations to help adults with moderate to severe tinnitus, which is a condition that causes ringing or noise in the ears. The main goal is to see if using this device can reduce the severity of tinnitus symptoms. Participants will use the device for 10 minutes every day over 8 weeks and will have some calls with the research team to track their progress. They will also complete assessments to measure how tinnitus affects their daily lives.

To join the study, participants need to be at least 22 years old and have experienced tinnitus for at least three months. They should be able to understand English and provide consent to participate. However, there are some people who cannot join, such as those with certain medical conditions or who have had recent treatments related to their tinnitus. It's important for potential participants to know that the study is not yet recruiting, but it aims to explore a new approach to managing tinnitus symptoms safely.

Gender

ALL

Eligibility criteria

• 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.