Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3 (TENT-A3)

December 22, 2022 updated by: Neuromod Devices Ltd.

Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3 (TENT-A3)

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 (sound and tongue) stimulation to alleviate the symptoms of chronic, subjective tinnitus. Participants presenting to one of the several study sites with a diagnosis of chronic subjective tinnitus who meet the inclusion criteria are enrolled in the investigation while the study site is active. The objective of TENT-A3 is to determine whether the addition of tongue stimulation to sound-only stimulation provides additional clinically significant improvements in tinnitus symptoms beyond that of the sound-only stimulation component of the bimodal treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 buzzing, hissing, clicking or other complex sounds. The condition affects approximately 10-15% of the global population. Many tinnitus sufferers report feeling distressed by their symptoms and report a resulting diminishment in their quality of life and that of their families. There are currently limited treatment options for those suffering from tinnitus. To address the unmet clinical need for a safe, effective, and scalable tinnitus treatment, Neuromod Devices developed a non-invasive bimodal (sound and tongue) stimulation device to alleviate the symptoms of chronic, subjective tinnitus. This CE marked device, known as Lenire, will be used in the TENT-A3 investigation, which is part of a series of bimodal neuromodulation investigations for the CE marked Lenire device for evaluating its safety and efficacy for tinnitus treatment. The Lenire device has three components: (1) headphones for presenting sound binaurally to the ears, (2) a tongue component for electrically stimulating the top surface of the tongue, and (3) a controller to control the stimulation patterns. TENT-A3 is a single arm repeated measures prospective investigation. Participants presenting to one of the several study sites with a diagnosis of chronic subjective tinnitus who meet the inclusion/exclusion criteria are enrolled in the investigation while the study site is active. The objective of TENT-A3 is to determine whether the addition of tongue stimulation to sound-only stimulation provides additional clinically significant improvements in tinnitus symptoms beyond that of the sound-only stimulation component of the bimodal treatment. Up to 112 participants are being enrolled in the study. Participants are involved with four visits that includes screening visit (up to 10 weeks before enrollment), enrollment visit (Week 0), interim visit (Week 6), and final visit (Week 12). Participants receive sound-only stimulation (PS6-No ETS: PS6 with No Electrical Tongue Stimulation) during Stage 1 (enrollment to interim vist) and bimodal stimulation (PS6) during Stage 2 (interim to final visit). Several outcome measures and evaluations are performed at each visit to assess the efficacy, safety, satisfaction, compliance and quality of life related to the Lenire treatment for tinnitus to address the primary, secondary and additional endpoints of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • BRAI3N
  • Germany
      • Hannover, Germany, 30625
        • German Hearing Center
  • Ireland
      • Dublin, Ireland, D08NHY1
        • The Wellcome HRB Clinical Research Facility at St. James's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Device: Lenire
The sound stimulus of PS6 is comprised of sequences of tones and is spectrally modified according to the participant's hearing thresholds so that different components of the sound stimulus can be sufficiently heard by the participant irrespective of their hearing characteristics (audiological profile). The tongue stimulus of PS6 is delivered by an array of electrical signals via 32 transmucosal electrodes contacting the anterodorsal surface of the tongue. The sound and tongue stimulus parameters are presented with certain stimulus rates and timing relationships between modalities.
Other Names:
  • Lenire treatment
  • Lenire device
  • Bimodal neuromodulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory (THI)
Time Frame: Enrollment visit to final visit (Week 0 to Week 12)
Responder rate in Stage 2 (the second 6-week period of treatment from interim visit to final visit comprising combined sound and tongue stimulation) compared to the point-estimate of the responder rate observed during Stage 1 (the first 6-week period of treatment from enrollment visit to interim visit comprising sound-only stimulation) based on THI.
Enrollment visit to final visit (Week 0 to Week 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tinnitus Functional Index (TFI)
Time Frame: Interim visit to final visit (Week 6 to Week 12)
Changes in symptoms of tinnitus as measured by TFI from the interim visit to the final visit.
Interim visit to final visit (Week 6 to Week 12)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heath Utilities Index Mark III (HUI3)
Time Frame: Screening visit to final visit (Screening to Week 12)
Changes in quality of life as measured by HUI3 from the screening visit to the interim visit and from the screening visit to the final visit.
Screening visit to final visit (Screening to Week 12)
Satisfaction Questions
Time Frame: Interim visit to final visit (Week 6 to Week 12)
Participant satisfaction rates with treatment as measured by two satisfaction questions at the final visit.
Interim visit to final visit (Week 6 to Week 12)
Tinnitus severity analysis on primary outcome measure
Time Frame: Enrollment visit to final visit (Week 0 to Week 12)
Primary outcome measure analyzed for different tinnitus severity groups based on clinically established THI categories (e.g., none/slight, mild, moderate, severe, catastrophic, THI >= 38, THI < 38)
Enrollment visit to final visit (Week 0 to Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neuromod Devices Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BRAI3N (clinical site), Belgium
St James's Hospital (clinical site), Ireland
German Hearing Center Hannover (clinical site), Germany
Avania (CRO/project manager), Netherlands

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Welmoed Gjaltema, Avania, Netherlands
  • Principal Investigator: Michael Boedts, BRAI3N, Belgium
  • Principal Investigator: Guan Khoo, St. James's Hospital, Ireland
  • Principal Investigator: Thomas Lenarz, German Hearing Center Hannover, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TENT-A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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