Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2019
CompletedFirst Submitted
Initial submission to the registry
February 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedFebruary 18, 2021
February 1, 2021
3 years
February 3, 2021
February 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Discomfort
Discomfort level is rated on a numerical scale, from 0 to 10, where 0 means "no discomfort" and 10 means "indescribable discomfort".
From baseline through study completion, an average of 10 months.
Secondary Outcomes (14)
Hyperacusis Symptoms change
From baseline through study completion, an average of 10 months.
Hyperacusis discomfort level
From baseline through study completion, an average of 10 months.
Tinnitus Symptoms change
From baseline through study completion, an average of 10 months.
Quality of life change
From baseline through study completion, an average of 10 months.
Sleep quality change
From baseline through study completion, an average of 10 months.
- +9 more secondary outcomes
Study Arms (2)
Tinnitus group
At least 20 patients suffering from tinnitus will be enrolled in the study.
Hyperacusis group
At least 20 patients suffering from hyperacusis will be enrolled in the study.
Interventions
The ØREBLUE® Method combines 2 inseparable therapeutic approaches that will be personalized, one dedicated to the auditory symptom (personalized sound therapy based on music and delivered through a helmet as part of the device), the other dedicated to the psychology of the subject. Sound rehabilitation will be based on successive treatment sequences. The 1st sequence includes 30 hours of listening, at a rate of 2 hours / day, 5 days a week. A period of 4 to 6 weeks is necessary before carrying out a new sequence. The second sequence (and subsequent ones when necessary, respecting a 4-to-6-weeks window in between) of sound rehabilitation consists of 20 hours distributed as for the first sequence.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hearing Institute of Resources
La Rochelle, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natacha CHETRITT-BONNEYRAT
Mayfair Developments
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2021
First Posted
February 12, 2021
Study Start
March 22, 2019
Primary Completion
March 30, 2022
Study Completion
January 1, 2023
Last Updated
February 18, 2021
Record last verified: 2021-02