Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method

• ClinicalTrials.gov Identifier: NCT04752176
• Recruitment Status: Unknown
• First Posted: February 12, 2021
• Last Update Posted: February 18, 2021
• Sponsor: Mayfair Developments
• Information provided by (Responsible Party): Mayfair Developments

Study Description

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.

Condition or disease	Intervention/treatment
Tinnitus; Hyperacusis	Device: ØREBLUE® Method

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

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method
• Actual Study Start Date: March 22, 2019
• Estimated Primary Completion Date: March 30, 2022
• Estimated Study Completion Date: January 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Tinnitus group; At least 20 patients suffering from tinnitus 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.
Hyperacusis group; 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.

Outcome Measures

Primary Outcome Measures :

1. 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".

Secondary Outcome Measures :

1. Hyperacusis Symptoms change [ Time Frame: From baseline through study completion, an average of 10 months. ]
   Hyperacusis symptoms are assessed with the Hyperacusis Handicap Inventory (HHI) questionnaire
2. Hyperacusis discomfort level [ Time Frame: From baseline through study completion, an average of 10 months. ]
   Disconfort level due to hyperacusis, in Decibels, during audiometric measurements
3. Tinnitus Symptoms change [ Time Frame: From baseline through study completion, an average of 10 months. ]
   Tinnitus symptoms are assessed with the Tinnitus Handicap Inventory (THI) questionnaire
4. Quality of life change [ Time Frame: From baseline through study completion, an average of 10 months. ]
   Quality of life is assessed through WHODAS 2.0 questionnaire
5. Sleep quality change [ Time Frame: From baseline through study completion, an average of 10 months. ]
   Sleep quality is assessed through the Pittsburgh Sleep Quality Index (PSQI)
6. Depression [ Time Frame: From baseline through study completion, an average of 10 months. ]
   Depression is assessed through the Beck Depression Inventory (BPI) questionnaire
7. Anxiety [ Time Frame: From baseline through study completion, an average of 10 months. ]
   Anxiety is assessed through the State-Trait Anxiety Inventory (STAI) questionnaire
8. Anxiety level [ Time Frame: From baseline through study completion, an average of 10 months. ]
   Anxiety level is rated on a numerical scale, from 0 to 10, where 0 means "no anxiety" and 10 means "worst anxiety".
9. Appetite level [ Time Frame: From baseline through study completion, an average of 10 months. ]
   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".
10. Energy level [ Time Frame: From baseline through study completion, an average of 10 months. ]
    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".
11. Emotionality [ Time Frame: From baseline through study completion, an average of 10 months. ]
    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".
12. Concentration ability [ Time Frame: From baseline through study completion, an average of 10 months. ]
    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".
13. Hopelessness feeling [ Time Frame: From baseline through study completion, an average of 10 months. ]
    Hopelessness feeling is rated on a numerical scale, from 0 to 10, where 0 means "no hopelessness feeling" and 10 means "worst hopelessness feeling".
14. Isolation feeling [ Time Frame: From baseline through study completion, an average of 10 months. ]
    Isolation feeling is rated on a numerical scale, from 0 to 10, where 0 means "no isolation feeling" and 10 means "worst isolation feeling".

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Contacts

Contact: Natacha CHETRITT-BONNEYRAT; (0)5 46 28 74 41 ext +33; contact@hir-france.com

Locations

France

Hearing Institute of Resources; Recruiting

La Rochelle, France

Contact: Natacha CHETRITT-BONNEYRAT (0)5 46 28 74 41 ext +33 nbonneyrat@mayfair-developments.com

Sponsors and Collaborators

Mayfair Developments

Investigators

• Principal Investigator: Natacha CHETRITT-BONNEYRAT; Mayfair Developments

More Information

• Responsible Party: Mayfair Developments
• ClinicalTrials.gov Identifier: NCT04752176
• Other Study ID Numbers: MAY001-PMCF001
• First Posted: February 12, 2021
• Last Update Posted: February 18, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mayfair Developments:

Tinnitus; hyperacusis; Medical device; ØREBLUE® Method

Additional relevant MeSH terms:

Tinnitus; Hyperacusis; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases