Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy (TIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04807686
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
Dr Quemar
Information provided by (Responsible Party):
Ramsay Générale de Santé

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tinnitus Device: Auditory simulation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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.




Primary Outcome Measures :
  1. Tinnitus Handicap Inventory [ Time Frame: 2 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807686


Contacts
Layout table for location contacts
Contact: JF OUDET +33683346567 jf.oudet@ecten.eu
Contact: MH Barba + 336 64 88 87 04 mh.barba@ecten.eu

Locations
Layout table for location information
France
Hôpital Privé Clairval Recruiting
Marseille, France, 13009
Contact: Anne Quemar    334 91 17 17 22      
Sponsors and Collaborators
Ramsay Générale de Santé
Dr Quemar
Investigators
Layout table for investigator information
Principal Investigator: Anne Quemar, Doctor Ramsay santé
Layout table for additonal information
Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT04807686    
Other Study ID Numbers: 2018-A02448-47
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases