Status:
UNKNOWN
Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method
Lead Sponsor:
Mayfair Developments
Conditions:
Tinnitus
Hyperacusis
Eligibility:
All Genders
18-85 years
Brief Summary
Tinnitus and hyperacusis are two hearing disorders that can severely impact the patient and their quality of life, as they may induce sleeping disorders, concentration troubles, social life disturbanc...
Detailed Description
Tinnitus is a clinical symptom indicative of abnormal stimulation of the auditory system characterized by the perception of chronic sound in the absence of an external sound source and that only the a...
Eligibility Criteria
Inclusion
- Age between 18 and 85 years old
- Subject seen in consultation in the investigational site from CE marking up to 2 years thereafter,
- Sufficient ENT investigations,
- Satisfactory general condition: non-invalidating medical history (ENT disorders and others),
- The subject agrees to work on the emotional part linked to their condition,
- Permanent and disabling tinnitus and/or hyperacusis, with the following characteristics for tinnitus: subjective, chronic (present for more than 1 year), resistant to usual treatments (medication, hearing aid with or without masking, psychotherapy) continued for a minimum of 6 months, severe tinnitus, disabling tinnitus (measurement with numerical scale score and THI questionnaire),
- Patient informed about the study and has no objection to take part
Exclusion
- Proven presence of an anxiety disorder of claustrophobia type,
- History of neurological disease, in particular personal or family history of epilepsy or seizure (infantile hyperthermic convulsions, or other type of seizure),
- Serious psychiatric history or attempted autolysis, concomitant use of antidepressant and neuroleptic treatment,
- Bilateral cophosis,
- Medication monitoring that can generate more or less tinnitus,
- More than 6 months since the end of the last treatment or therapy against tinnitus,
- For women: possibility of pregnancy (absence of effective contraception or certain menopause), breastfeeding woman,
- Context of medico-legal litigation and / or concomitant participation in another protocol.
Key Trial Info
Start Date :
March 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04752176
Start Date
March 22 2019
End Date
January 1 2023
Last Update
February 18 2021
Active Locations (1)
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1
Hearing Institute of Resources
La Rochelle, France