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

February 16, 2021 updated by: Mayfair Developments
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
From baseline through study completion, an average of 10 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Disconfort level due to hyperacusis, in Decibels, during audiometric measurements
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.
Tinnitus symptoms are assessed with the Tinnitus Handicap Inventory (THI) questionnaire
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.
Quality of life is assessed through WHODAS 2.0 questionnaire
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.
Sleep quality is assessed through the Pittsburgh Sleep Quality Index (PSQI)
From baseline through study completion, an average of 10 months.
Depression
Time Frame: From baseline through study completion, an average of 10 months.
Depression is assessed through the Beck Depression Inventory (BPI) questionnaire
From baseline through study completion, an average of 10 months.
Anxiety
Time Frame: From baseline through study completion, an average of 10 months.
Anxiety is assessed through the State-Trait Anxiety Inventory (STAI) questionnaire
From baseline through study completion, an average of 10 months.
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".
From baseline through study completion, an average of 10 months.
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".
From baseline through study completion, an average of 10 months.
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".
From baseline through study completion, an average of 10 months.
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".
From baseline through study completion, an average of 10 months.
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".
From baseline through study completion, an average of 10 months.
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".
From baseline through study completion, an average of 10 months.
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".
From baseline through study completion, an average of 10 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayfair Developments

Investigators

  • Principal Investigator: Natacha CHETRITT-BONNEYRAT, Mayfair Developments

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2019

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAY001-PMCF001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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