Back to resultsAttenuation of Tonal Tinnitus by Lateral Inhibition Therapy (TIL)
Primary Purpose
Tinnitus
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auditory simulation
Sponsored by
About this trial
This is an interventional supportive care trial for Tinnitus
Eligibility 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
Sites / Locations
- Hôpital Privé ClairvalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
traditional algorithm
notched-type algorithm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04807686
First Posted
March 17, 2021
Last Updated
March 17, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
Dr Quemar
1. Study Identification
Unique Protocol Identification Number
NCT04807686
Brief Title
Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy
Acronym
TIL
Official Title
Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Dr Quemar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional algorithm
Arm Type
Active Comparator
Arm Title
notched-type algorithm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Auditory simulation
Intervention Description
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 Measure Information:
Title
Tinnitus Handicap Inventory
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JF OUDET
Phone
+33683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
MH Barba
Phone
+ 336 64 88 87 04
Email
mh.barba@ecten.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Quemar, Doctor
Organizational Affiliation
Ramsay santé
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Privé Clairval
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Quemar
Phone
334 91 17 17 22
12. IPD Sharing Statement
Learn more about this trial
Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy
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