Status:
COMPLETED
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3
Lead Sponsor:
Neuromod Devices Ltd.
Collaborating Sponsors:
BRAI3N (clinical site), Belgium
St. James's Hospital, Ireland
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
TENT-A3 is a single arm repeated measures prospective investigation evaluating the safety and efficacy of the Lenire device for tinnitus treatment. The Lenire device provides non-invasive bimodal (sou...
Detailed Description
Tinnitus is the perception of sound in the absence of a corresponding external acoustic stimulus. The condition is most commonly referred to as 'ringing in the ears' but symptoms can manifest as buzzi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05227365
Start Date
March 21 2022
End Date
October 25 2022
Last Update
December 27 2022
Active Locations (3)
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1
BRAI3N
Ghent, Belgium, 9000
2
German Hearing Center
Hanover, Germany, 30625
3
The Wellcome HRB Clinical Research Facility at St. James's Hospital
Dublin, Ireland, D08NHY1