Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy (TIL)

Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

Study Overview

• Status: Recruiting
• Conditions: Tinnitus
• Intervention / Treatment: Device: Auditory simulation

Detailed Description

In France, up to 16 million people suffer from tinnitus or ringing in the ears daily. This parasitic sound that does not come from the patient's environment can interfere with each individual in a variable way, sometimes creating an insurmountable handicap which has not known any effective treatment validated to date.

Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MH Barba; Phone Number: + 336 64 88 87 04; Email: mh.barba@ecten.eu

Study Locations

• France
  • Marseille, France, 13009
    • Recruiting
    • Hôpital privé Clairval
    • Contact: Anne Quemar; Phone Number: 334 91 17 17 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient over 18 years old.
• Patient with disabling tonal tinnitus (THI score> 40) for more than 6 months.
• Patient with a hearing loss of at least 25dB, centered on the frequency of tinnitus and requiring hearing aids
• Patient who has never used a hearing aid or a tinnitus masking system.
• Patient who stopped all tinnitus treatment at least 1 month before the start of the study (drug treatment, psychotherapy).
• Patient being willing to attend all of the visits planned as part of the study.
• Patient affiliated or beneficiary of a social security scheme.
• Patient having signed the free and informed consent

Exclusion Criteria:

• Minor patient.
• Patient with hyperacusis
• Patient already with a hearing aid or tinnitus masker.
• Patient undergoing psychotropic or neurotropic drug treatments.
• Patient with a history of psychological or psychiatric disorders.
• Patient with a contraindication to wearing hearing aids.
• Patient suffering from non-disabling tinnitus (THI score <40).
• Patient suffering from intermittent, non-tonal or pulsatile tinnitus.
• Patient participating in another clinical study.
• Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision.
• Pregnant or breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: traditional algorithm	Device: Auditory simulation; Each patient will be delivered each of the 2 auditory stimulation protocols considered in the context of the research: stimulation with a traditional algorithm called AT and stimulation with a notched-type algorithm called AE. The order in which will be carried out, for the same patient, each of these 2 protocols (AT then AE or AE then AT) will be randomized.
Experimental: notched-type algorithm	Device: Auditory simulation; Each patient will be delivered each of the 2 auditory stimulation protocols considered in the context of the research: stimulation with a traditional algorithm called AT and stimulation with a notched-type algorithm called AE. The order in which will be carried out, for the same patient, each of these 2 protocols (AT then AE or AE then AT) will be randomized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Handicap Inventory	The primary endpoint is the score (out of 100 points) obtained on the Tinnitus Handicap Inventory (THI), expressed in terms of variation from the baseline.	2 months

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: Dr Quemar
• Investigators: Principal Investigator: Anne Quemar, Doctor, Ramsay santé

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 2018-A02448-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No