Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3 (TENT-A3)
Tinnitus
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- 18 years and over at time of consent
- Ability to read and understand Dutch, Flemish, English or German (depending on the site)
- Willing and able to provide and understand informed consent
- Willing to commit to the full duration of the investigation
- Subjective tinnitus
- Tinnitus duration for greater than or equal to 3 months and less than or equal to 10 years at time of consent
- Baseline THI greater than or equal to 38
Exclusion Criteria:
- 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
- Oral piercings that cannot or will not be removed for the second stage of the investigation
- Neurological condition that may lead to seizures or loss of consciousness (e.g. epilepsy)
- Severe cognitive impairment based on MMSE (score less than 20)
- Participant with a pacemaker or other electro-active implanted device
- Abnormal findings following otoscopy/tympanometry that may be contributing to or causing the tinnitus as assessed by an Audiologist/ENT
- Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, by discretion of the investigator
- Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, by discretion of the investigator
- STAI score of >120
- Current or previous involvement in medico-legal cases (self-reported)
- Participant previously diagnosed with psychosis or schizophrenia
- Participants diagnosed with burning mouth syndrome
- Previous use of Lenire
- 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
- The site PI does not deem the candidate to be suitable for the investigation for other reasons not listed above
Sites / Locations
- BRAI3N
- German Hearing Center
- The Wellcome HRB Clinical Research Facility at St. James's Hospital
Arms of the Study
Arm 1
Other
Single Treatment Arm Study
The Lenire device is a CE marked medical device intended to reduce the symptoms of tinnitus. It comprises a handheld controller, an intra-oral device called a Tonguetip that delivers gentle electrical stimulation to the tongue, and a set of wireless headphones that deliver audio stimulation to the ears. The sound and tongue stimulation are configured and calibrated to individual participant hearing and sensation characteristics during the initial fitting procedure completed by a trained clinician. The participants will receive 12 weeks of treatment, in which the first 6-weeks will consist of sound-only stimulation (PS6-No ETS) and the second 6-weeks will consist of bimodal stimulation (PS6, includes sound and tongue stimulation).