An observational study in Tinnitus and Hyperacusis, sponsored by Mayfair Developments. Status unknown at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Mayfair Developments · Observational
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.
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.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 57 observational studies indexed under Tinnitus.
Browse Tinnitus studies →This is the only study on the registry with Mayfair Developments as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At least 20 patients suffering from tinnitus will be enrolled in the study.
Device: ØREBLUE® Method
At least 20 patients suffering from hyperacusis will be enrolled in the study.
Device: ØREBLUE® Method
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.
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".
Time frame: From baseline through study completion, an average of 10 months.
Hyperacusis Symptoms change
Hyperacusis symptoms are assessed with the Hyperacusis Handicap Inventory (HHI) questionnaire
Time frame: From baseline through study completion, an average of 10 months.
Hyperacusis discomfort level
Disconfort level due to hyperacusis, in Decibels, during audiometric measurements
Time frame: From baseline through study completion, an average of 10 months.
Tinnitus Symptoms change
Tinnitus symptoms are assessed with the Tinnitus Handicap Inventory (THI) questionnaire
Time frame: From baseline through study completion, an average of 10 months.
Quality of life change
Quality of life is assessed through WHODAS 2.0 questionnaire
Time frame: From baseline through study completion, an average of 10 months.
Sleep quality change
Sleep quality is assessed through the Pittsburgh Sleep Quality Index (PSQI)
Time frame: From baseline through study completion, an average of 10 months.
Depression
Depression is assessed through the Beck Depression Inventory (BPI) questionnaire
Time frame: From baseline through study completion, an average of 10 months.
Anxiety
Anxiety is assessed through the State-Trait Anxiety Inventory (STAI) questionnaire
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: From baseline through study completion, an average of 10 months.
Started Mar 2019 (actual). Primary completion is estimated for Mar 2022, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.