TinnitusNCT04752176
Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method
An observational study of Tinnitus and Hyperacusis, run by Mayfair Developments at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tinnitus, Hyperacusis
- What is being tested?
- ØREBLUE® Method
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2019to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hearing Institute of Resources
La Rochelle
Natacha CHETRITT-BONNEYRAT, (0)5 46 28 74 41 ext. +33, nbonneyrat@mayfair-developments.com
About this study
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.
Read the 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.
- Conditions
- Tinnitus, Hyperacusis
- Being tested
- ØREBLUE® Method
- Keywords
- Tinnitus, hyperacusis, Medical device, ØREBLUE® Method
- Medical subject headings
- Tinnitus, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ØREBLUE® MethodDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Tinnitus group | At least 20 patients suffering from tinnitus will be enrolled in the study. Receives: Device: ØREBLUE® Method | |
| Hyperacusis group | At least 20 patients suffering from hyperacusis will be enrolled in the study. Receives: Device: ØREBLUE® Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: From baseline through study completion, an average of 10 months.
Secondary outcomes (14)
Hyperacusis Symptoms change
Hyperacusis symptoms are assessed with the Hyperacusis Handicap Inventory (HHI) questionnaire
Measured: From baseline through study completion, an average of 10 months.
Hyperacusis discomfort level
Disconfort level due to hyperacusis, in Decibels, during audiometric measurements
Measured: From baseline through study completion, an average of 10 months.
Tinnitus Symptoms change
Tinnitus symptoms are assessed with the Tinnitus Handicap Inventory (THI) questionnaire
Measured: From baseline through study completion, an average of 10 months.
Quality of life change
Quality of life is assessed through WHODAS 2.0 questionnaire
Measured: From baseline through study completion, an average of 10 months.
Sleep quality change
Sleep quality is assessed through the Pittsburgh Sleep Quality Index (PSQI)
Measured: From baseline through study completion, an average of 10 months.
Depression
Depression is assessed through the Beck Depression Inventory (BPI) questionnaire
Measured: From baseline through study completion, an average of 10 months.
Anxiety
Anxiety is assessed through the State-Trait Anxiety Inventory (STAI) questionnaire
Measured: From baseline through study completion, an average of 10 months.
Anxiety level
Anxiety level is rated on a numerical scale, from 0 to 10, where 0 means "no anxiety" and 10 means "worst anxiety".
Measured: From baseline through study completion, an average of 10 months.
Appetite level
Appetite level is rated on a numerical scale, from 0 to 10, where 0 means "no impact on appetite" and 10 means "worst impact on appetite".
Measured: From baseline through study completion, an average of 10 months.
Energy level
Energy level is rated on a numerical scale, from 0 to 10, where 0 means "no impact on energy" and 10 means "worst impact on energy".
Measured: From baseline through study completion, an average of 10 months.
Emotionality
Emotionality is rated on a numerical scale, from 0 to 10, where 0 means "no impact on emotionality" and 10 means "worst impact on emotionality".
Measured: From baseline through study completion, an average of 10 months.
Concentration ability
Concentration ability is rated on a numerical scale, from 0 to 10, where 0 means "no impact on concentration ability" and 10 means "worst impact on concentration ability".
Measured: From baseline through study completion, an average of 10 months.
Hopelessness feeling
Hopelessness feeling is rated on a numerical scale, from 0 to 10, where 0 means "no hopelessness feeling" and 10 means "worst hopelessness feeling".
Measured: From baseline through study completion, an average of 10 months.
Isolation feeling
Isolation feeling is rated on a numerical scale, from 0 to 10, where 0 means "no isolation feeling" and 10 means "worst isolation feeling".
Measured: From baseline through study completion, an average of 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start22 Mar 2019
- Primary completion30 Mar 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayfair Developments
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natacha CHETRITT-BONNEYRAT, Principal investigator, Mayfair Developments
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752176
- Sponsor's protocol ID
- MAY001-PMCF001
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method
- ClinicalTrials.gov ID
- NCT04752176
- Acronym / sponsor ID
- MAY001-PMCF001
- Conditions
- Tinnitus, Hyperacusis
- Keywords
- Tinnitus, hyperacusis, Medical device, ØREBLUE® Method
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayfair DevelopmentsIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tinnitus group | – | Device: ØREBLUE® MethodAt least 20 patients suffering from tinnitus will be enrolled in the study. |
| Hyperacusis group | – | Device: ØREBLUE® MethodAt least 20 patients suffering from hyperacusis will be enrolled in the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ØREBLUE® MethodThe 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. | Device | Hyperacusis group, Tinnitus group |
Primary outcome
Change in Discomfort
Time frame: From baseline through study completion, an average of 10 months.
Discomfort level is rated on a numerical scale, from 0 to 10, where 0 means "no discomfort" and 10 means "indescribable discomfort".
14 secondary outcomes
Hyperacusis Symptoms change
Time frame: From baseline through study completion, an average of 10 months.
Hyperacusis discomfort level
Time frame: From baseline through study completion, an average of 10 months.
Tinnitus Symptoms change
Time frame: From baseline through study completion, an average of 10 months.
Quality of life change
Time frame: From baseline through study completion, an average of 10 months.
Sleep quality change
Time frame: From baseline through study completion, an average of 10 months.
Depression
Time frame: From baseline through study completion, an average of 10 months.
Anxiety
Time frame: From baseline through study completion, an average of 10 months.
Anxiety level
Time frame: From baseline through study completion, an average of 10 months.
Appetite level
Time frame: From baseline through study completion, an average of 10 months.
Energy level
Time frame: From baseline through study completion, an average of 10 months.
Emotionality
Time frame: From baseline through study completion, an average of 10 months.
Concentration ability
Time frame: From baseline through study completion, an average of 10 months.
Hopelessness feeling
Time frame: From baseline through study completion, an average of 10 months.
Isolation feeling
Time frame: From baseline through study completion, an average of 10 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natacha CHETRITT-BONNEYRAT principal investigator
Mayfair Developments
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus and Hyperacusis, run by Mayfair Developments at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha CHETRITT-BONNEYRAT ((0)5 46 28 74 41 ext. +33, contact@hir-france.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Discomfort (time frame: From baseline through study completion, an average of 10 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.