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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lenire
Sponsored by
Neuromod Devices Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Other

Arm Label

Single Treatment Arm Study

Arm Description

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).

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory (THI)
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.

Secondary Outcome Measures

Tinnitus Functional Index (TFI)
Changes in symptoms of tinnitus as measured by TFI from the interim visit to the final visit.

Full Information

First Posted
January 26, 2022
Last Updated
December 22, 2022
Sponsor
Neuromod Devices Ltd.
Collaborators
BRAI3N (clinical site), Belgium, St James's Hospital (clinical site), Ireland, German Hearing Center Hannover (clinical site), Germany, Avania (CRO/project manager), Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT05227365
Brief Title
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3
Acronym
TENT-A3
Official Title
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3 (TENT-A3)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuromod Devices Ltd.
Collaborators
BRAI3N (clinical site), Belgium, St James's Hospital (clinical site), Ireland, German Hearing Center Hannover (clinical site), Germany, Avania (CRO/project manager), Netherlands

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-site, single-arm repeated measures prospective investigation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Treatment Arm Study
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Lenire
Other Intervention Name(s)
Lenire treatment, Lenire device, Bimodal neuromodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
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.
Time Frame
Enrollment visit to final visit (Week 0 to Week 12)
Secondary Outcome Measure Information:
Title
Tinnitus Functional Index (TFI)
Description
Changes in symptoms of tinnitus as measured by TFI from the interim visit to the final visit.
Time Frame
Interim visit to final visit (Week 6 to Week 12)
Other Pre-specified Outcome Measures:
Title
Heath Utilities Index Mark III (HUI3)
Description
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.
Time Frame
Screening visit to final visit (Screening to Week 12)
Title
Satisfaction Questions
Description
Participant satisfaction rates with treatment as measured by two satisfaction questions at the final visit.
Time Frame
Interim visit to final visit (Week 6 to Week 12)
Title
Tinnitus severity analysis on primary outcome measure
Description
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)
Time Frame
Enrollment visit to final visit (Week 0 to Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Welmoed Gjaltema
Organizational Affiliation
Avania, Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Boedts
Organizational Affiliation
BRAI3N, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guan Khoo
Organizational Affiliation
St. James's Hospital, Ireland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Lenarz
Organizational Affiliation
German Hearing Center Hannover, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
BRAI3N
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
German Hearing Center
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
The Wellcome HRB Clinical Research Facility at St. James's Hospital
City
Dublin
ZIP/Postal Code
D08NHY1
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33028707
Citation
Conlon B, Langguth B, Hamilton C, Hughes S, Meade E, Connor CO, Schecklmann M, Hall DA, Vanneste S, Leong SL, Subramaniam T, D'Arcy S, Lim HH. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Sci Transl Med. 2020 Oct 7;12(564):eabb2830. doi: 10.1126/scitranslmed.abb2830.
Results Reference
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Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3

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