Clinical trial NCT04752176: Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method
Official title: Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tinnitus
Hyperacusis
Keywords: Tinnitus
hyperacusis
Medical device
ØREBLUE® Method
Lead sponsor: Mayfair Developments
Sponsor class: INDUSTRY
First posted: 2021-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be retrospectively collected from consecutive patients suffering from tinnitus and/or hyperacusis and treated in the investigational site by the ØREBLUE® Method since the CE marking date and up to 3 years-time.

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 disturbances. Mayfair Developments has created and developed the innovating ØREBLUE® method in order to relieve, possibly completely, tinnitus and hyperacusis symptoms. The ØREBLUE® method relies on a medical device, CE marked, that consists of an auditory stimulation box associated with five softwares. This medical device diffuses thanks to a headphone a specific and personalized sound therapy treatment for the patient. This retrospective, observational study aims at collecting data about the ØREBLUE® method used in routine care and describing its efficacy on tinnitus and hyperacusis.

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 affected subject perceives intrusively.Its presence can occur independently unilaterally, bilaterally, or be described as perceived in the center of the head and can be heard continuously or intermittently at varying levels of intensity and frequency. There are two types of tinnitus depending on whether it can be detected with a stethoscope by the doctor (objective tinnitus) or only heard by the subject (subjective tinnitus). Many consequences, such as anxiety, depression and sleep disorders, linked to suffering from tinnitus will impact daily life in different forms.

Both types of tinnitus may be accompanied by a higher intolerance to noise which is called hyperacusis.Hyperacusis is defined as an intolerance (and not a finer sensitivity to sounds) to environmental sound levels, the intensity of which, of varying intensity, represents neither risk nor inconvenience for people with normal hearing, but which induces discomfort or pain in people with hyperacusis.

In these clinical situations, the ØREBLUE® method is an innovative treatment with the objective of eliminating the symptoms of tinnitus and hyperacusis depending on the group to which the subject belongs. Its innovative character is based on the design of a sound signal processing device, CE marked as medical device, developed by Mayfair Developments. This technological innovation has been developed to respond specifically to the hearing profile of each subject and to provide personalized rehabilitation of their hearing sphere.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Discomfort
timeFrame: From baseline through study completion, an average of 10 months.
Secondary outcomes:
measure: Hyperacusis Symptoms change
timeFrame: From baseline through study completion, an average of 10 months.
measure: Hyperacusis discomfort level
timeFrame: From baseline through study completion, an average of 10 months.
measure: Tinnitus Symptoms change
timeFrame: From baseline through study completion, an average of 10 months.
measure: Quality of life change
timeFrame: From baseline through study completion, an average of 10 months.
measure: Sleep quality change
timeFrame: From baseline through study completion, an average of 10 months.
measure: Depression
timeFrame: From baseline through study completion, an average of 10 months.
measure: Anxiety
timeFrame: From baseline through study completion, an average of 10 months.
measure: Anxiety level
timeFrame: From baseline through study completion, an average of 10 months.
measure: Appetite level
timeFrame: From baseline through study completion, an average of 10 months.
measure: Energy level
timeFrame: From baseline through study completion, an average of 10 months.
measure: Emotionality
timeFrame: From baseline through study completion, an average of 10 months.
measure: Concentration ability
timeFrame: From baseline through study completion, an average of 10 months.
measure: Hopelessness feeling
timeFrame: From baseline through study completion, an average of 10 months.
measure: Isolation feeling
timeFrame: From baseline through study completion, an average of 10 months.
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Hearing Institute of Resources
Study officials:
affiliation: Mayfair Developments
name: Natacha CHETRITT-BONNEYRAT
role: PRINCIPAL_INVESTIGATOR
References: