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Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A) | Clinical Trials | Clareo Health

COMPLETEDNA

Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

NCT02669069•Neuromod Devices Ltd.

View on ClinicalTrials.gov

Summary

This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Detailed Description

Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Devices will be programmed with one of 3 stimulation parameter settings. After 12 weeks of use, differences in tinnitus severity scores will be compared between the 3 arms and within the arms for patient subtype analysis.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 to 70 years of age
•The ability to read and understand English/German
•Willing and able to provide informed consent
•Willing to commit to the full duration of the study
•Have been experiencing tinnitus 3 months to 5 years
•Experiencing subjective tinnitus
•Baseline Tinnitus Handicap Inventory (THI) score of 28 to 76 points
•Baseline Minimum Masking Level (MML) of 20 to 80 dBHL
•Maximum AC pure-tone audiometry hearing loss of 80 dB HL at any test frequency in the range of 2 to 8 kHz or of 40 dB HL in the range of 250 to 1000 Hz either unilaterally or bi-laterally

Exclusion Criteria

•If participant has been diagnosed with objective tinnitus
•Commenced usage of hearing aid within the last 90 days
•Cases where pulsatility is the dominant feature of tinnitus
•Patients whose tinnitus cannot be masked during MML assessment
•Meniere's disease
•Significantly severe Loudness Discomfort Level (LDL), \<30 dB SL
•Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) scores greater than 120
•Diagnosed with somatic tinnitus resulting from head or neck injury
•Temporomandibular Joint Disorder (TMJ)
•Current or previous involvement in medico-legal cases
+11 more criteria

Locations (2)

University Hospital Regensburg

Regensburg, Germany

St. James's Wellness Trust Clinical Research Facility

Dublin, Ireland

Key Dates

Start Date

June 27, 2016

Primary Completion Date

July 31, 2017

Completion Date

January 30, 2019

Last Updated

December 20, 2024

Enrollment

326

ACTUAL participants

Conditions

Tinnitus

Interventions

PS1

DEVICE

PS2

DEVICE

PS3

DEVICE

Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus

NCT07393880

Tinnitus, SubjectiveTinnitus+1 more

View study

RECRUITINGNA

Noninvasive Therapy for Tinnitus

NCT07071480

TinnitusTinnitus, Subjective

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

Inclusion Criteria

Exclusion Criteria

Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus

Noninvasive Therapy for Tinnitus

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

Treatment for PTSD and Tinnitus

Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia

Somatic Tracking for Tinnitus