Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3

NCT05227365 | Completed

• 1 other identifier: TENT-A3
• Study Type: interventional
• Target: 112
• Locations: 3 countries
• Sites: 3

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• 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.

  Enrollment visit to final visit (Week 0 to Week 12)

Secondary Outcomes (1)

• Tinnitus Functional Index (TFI)

  Interim visit to final visit (Week 6 to Week 12)

Other Outcomes (3)

• Heath Utilities Index Mark III (HUI3)

  Screening visit to final visit (Screening to Week 12)

• Satisfaction Questions

  Interim visit to final visit (Week 6 to Week 12)

• Tinnitus severity analysis on primary outcome measure

  Enrollment visit to final visit (Week 0 to Week 12)

Study Arms (1)

Single Treatment Arm Study

OTHER

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

Interventions

Lenire DEVICE

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.

Also known as: Lenire treatment, Lenire device, Bimodal neuromodulation

Single Treatment Arm Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuromod Devices Ltd.: lead
• BRAI3N (clinical site), Belgium: collaborator
• St. James's Hospital, Ireland: collaborator
• German Hearing Center Hannover (clinical site), Germany: collaborator
• Avania (CRO/project manager), Netherlands: collaborator

Study Sites (3)

BRAI3N

Ghent, 9000, Belgium

Location

German Hearing Center

Hanover, 30625, Germany

Location

The Wellcome HRB Clinical Research Facility at St. James's Hospital

Dublin, D08NHY1, Ireland

Location

Related Publications (1)

• 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.

  PMID: 33028707 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Welmoed Gjaltema

  Avania, Netherlands

  STUDY DIRECTOR

• Michael Boedts

  BRAI3N, Belgium

  PRINCIPAL INVESTIGATOR

• Guan Khoo

  St. James's Hospital, Ireland

  PRINCIPAL INVESTIGATOR

• Thomas Lenarz

  German Hearing Center Hannover, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-site, single-arm repeated measures prospective investigation.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: March 21, 2022
• Primary Completion: September 6, 2022
• Study Completion: October 25, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

IE (1); DE (1); BE (1)