NCT04807686

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

March 17, 2021

Last Update Submit

March 17, 2021

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

traditional algorithm

ACTIVE COMPARATOR
Device: Auditory simulation

notched-type algorithm

EXPERIMENTAL
Device: Auditory simulation

Interventions

Auditory simulationDEVICE

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.

notched-type algorithmtraditional algorithm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Clairval

Marseille, 13009, France

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Quemar, Doctor

    Ramsay santé

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JF OUDET

CONTACT

+33683346567jf.oudet@ecten.eu

MH Barba

CONTACT

+ 336 64 88 87 04mh.barba@ecten.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 19, 2021

Study Start

July 19, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

FR(1)