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Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy (TIL)

R

Ramsay Générale de Santé

Status

Unknown

Conditions

Tinnitus

Treatments

Device: Auditory simulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04807686
2018-A02448-47

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

29 participants in 2 patient groups

traditional algorithm
Active Comparator group
Treatment:
Device: Auditory simulation
notched-type algorithm
Experimental group
Treatment:
Device: Auditory simulation

Trial contacts and locations

1

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Central trial contact

MH Barba; JF OUDET

Data sourced from clinicaltrials.gov

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