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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752176
• Other study ID #: MAY001-PMCF001
• Status: Recruiting
• Start date: March 22, 2019
• Est. completion date: January 2023

Study information

• Verified date: February 2021
• Source: Mayfair Developments
• Contact: Natacha CHETRITT-BONNEYRAT
• Phone: (0)5 46 28 74 41
• Email: contact[@]hir-france.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2023
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperacusis
• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
France	Hearing Institute of Resources	La Rochelle

Sponsors (1)

Lead Sponsor	Collaborator
Mayfair Developments

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hyperacusis Symptoms change	Hyperacusis symptoms are assessed with the Hyperacusis Handicap Inventory (HHI) questionnaire	From baseline through study completion, an average of 10 months.
Secondary	Hyperacusis discomfort level	Disconfort level due to hyperacusis, in Decibels, during audiometric measurements	From baseline through study completion, an average of 10 months.
Secondary	Tinnitus Symptoms change	Tinnitus symptoms are assessed with the Tinnitus Handicap Inventory (THI) questionnaire	From baseline through study completion, an average of 10 months.
Secondary	Quality of life change	Quality of life is assessed through WHODAS 2.0 questionnaire	From baseline through study completion, an average of 10 months.
Secondary	Sleep quality change	Sleep quality is assessed through the Pittsburgh Sleep Quality Index (PSQI)	From baseline through study completion, an average of 10 months.
Secondary	Depression	Depression is assessed through the Beck Depression Inventory (BPI) questionnaire	From baseline through study completion, an average of 10 months.
Secondary	Anxiety	Anxiety is assessed through the State-Trait Anxiety Inventory (STAI) questionnaire	From baseline through study completion, an average of 10 months.
Secondary	Anxiety level	Anxiety level is rated on a numerical scale, from 0 to 10, where 0 means "no anxiety" and 10 means "worst anxiety".	From baseline through study completion, an average of 10 months.
Secondary	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".	From baseline through study completion, an average of 10 months.
Secondary	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".	From baseline through study completion, an average of 10 months.
Secondary	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".	From baseline through study completion, an average of 10 months.
Secondary	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".	From baseline through study completion, an average of 10 months.
Secondary	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".	From baseline through study completion, an average of 10 months.
Secondary	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".	From baseline through study completion, an average of 10 months.