Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus

  • STATUS
    Recruiting
  • End date
    Aug 30, 2023
  • participants needed
    20
  • sponsor
    University of Minnesota
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Updated on 23 October 2022
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audiogram

Summary

The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the ability to self-adjust the sound stimulus presented to the ears via headphones. In particular, the CE marked bimodal stimulation portable device, Lenire, which is developed by Neuromod Devices Limited (Dublin, Ireland) to alleviate the symptoms of chronic subjective tinnitus, is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during fitting in a hearing center. Lenire device is a non-invasive stimulation device that consists of a controller that connects to headphones for sound delivery to the ears and connects to a mouth component that provides gentle electrical stimulation to the tongue surface. Individuals are recommended to use the device for 60 minutes daily (two 30-minute sessions consecutively or at different times of the day) for at least 10 weeks. Lenire is already commercialized across Europe and available by audiologists or hearing technicians in numerous hearing centers for treating tinnitus. It has also been evaluated in two large-scale clinical trials in over 500 tinnitus participants, demonstrating tinnitus benefit and minimal risk with high compliance and satisfaction rates.

The primary objective of the proposed usability study is to first assess compliance and satisfaction with the Lenire device that does not require an audiogram for fitting and that can be implemented mostly through virtual visits (except for the first visit). These modifications to the Lenire fitting process will reduce the time and personnel effort required for its implementation, enabling a broader patient population to access bimodal stimulation for tinnitus treatment, including military personnel and those who are not nearby hearing centers for in-person sessions. High compliance and satisfaction rates from this small proof-of concept usability study will then justify and guide a larger clinical study to assess efficacy and performance of this newly implemented Lenire device process.

Details
Condition Tinnitus
Treatment Lenire bimodal stimulation device
Clinical Study IdentifierNCT05518682
SponsorUniversity of Minnesota
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

years and over at time of consent
Ability to read and understand English
Willing and able to provide and understand informed consent
Willing to commit to the full duration of the investigation
Subjective tinnitus
Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent
Baseline THI score from 38 to 76
Hearing loss condition (low hearing loss group (n=10) and high hearing loss group (n=10))
Access to reliable internet connection and device to complete virtual video visits and electronic surveys

Exclusion Criteria

Subjective tinnitus, where pulsatility is the dominant feature
Objective tinnitus
Middle ear pathology in either ear including documented/known conductive hearing loss >= 20 dB at three adjacent frequencies or if a diagnosis of a tympanic membrane perforation or other middle ear pathology has been rendered, if there is an indwelling pressure equalization tube by patient report, or if middle ear surgery has been performed
Began wearing hearing aids within the past 3 months
Health care provider has rendered a diagnosis of Meniere's disease or other disorder with fluctuating hearing loss
A diagnosis of hyperacusis, misophonia or hypersensitivity to loud noises has been rendered
History of auditory hallucinations
Tumor on the hearing or balance nervous systems
Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments
Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments
Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments
Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
Participant with a pacemaker or other electro-active implanted device
Participant previously diagnosed with psychosis or schizophrenia
Participants diagnosed with Burning Mouth Syndrome
A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus
Inability to physically or comprehensively use the device
Oral piercings that cannot or will not be removed
Current or previous involvement in medico-legal cases
Pregnancy per patient report
Prisoner
PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided
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