Moderate to Severe Hearing LossIOM laserNCT02845115
Surgical Optimizing of a Middle Ear Implant (MET )With Laser Velocimetry in Patients With Moderate to Severe Hearing Loss in Case of Failure of Conventional Equipment
A study testing Conventional implantation and optimized implantation with laser velocimetry in people with Moderate to Severe Hearing Loss and Indication of Middle Ear Implant (MET), run by Hospices Civils de Lyon.
Trial summary
The aging of the population, and greater exposure to noise, are responsible for an increased incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that has become a real public health problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Hearing Loss, Indication of Middle Ear Implant (MET)
- What is being tested?
- Conventional implantation and optimized implantation with laser velocimetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 60 years;
- Having given written informed consent prior to any procedure related to the study;
- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
- Indication and IOM implantation request by the patient with a patient physically, psychologically and legally able to ask its implementation
- Average deafness to severe (mean thresholds between 40 to 90 dB) with speech discrimination> 40% to 75 dB.
- Deafness of pure perception or mixed hearing loss
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- Non-fluctuating deafness over the last two years
- Failed or cons-indication to conventional equipment
- Rocky Scanner and MRI normal brain
- Patient fluent in French (to ensure validity audiological measures
Who cannot join
- Pregnant women or likely to be during the study.
- Not affiliated with a social security scheme Patients
- Major Patients protected by provisions of the law (Public Health Code).
- Refusal of consent.
- Ongoing Participation in another study that may interfere with the proposed study (investigator assessment).
- Existence of a cons-indication for surgery or port of the implant
Show all 12Show fewer
- Motivation only aesthetic, evaluated by the principal investigator.
- Inability of predictable medium-term monitoring.
- Acoustic neuroma, tumors and other evolutionary processes of the rock and the cerebellopontine angle.
- Pathology requiring follow-up MRI (IOM against-indicating MRI).
- Patient with against-indication to MRI.
- Contraindication to the establishment of a pacemaker ossicular MET
About this study
Official title: Pilot Study Evaluating Surgical Optimizing of a Middle Ear Implant (MET )With Laser Velocimetry in Patients With Moderate to Severe Hearing Loss in Case of Failure of Conventional Equipment
The aging of the population, and greater exposure to noise, are responsible for an increased incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that has become a real public health problem. The main means of rehabilitation of this disability is represented by the apparatus of patients with conventional hearing aids. However, these hearing aids have several drawbacks that limit their profits, often abandoning the prosthesis by the patient.
Middle ear implants were developed to answer these problems. They are intended to amplify the sound signal by transmitting directly to the middle ear to compensate for the hearing loss and are indicated in case of failure or contraindication of conventional equipment. However, these middle ear implants currently have limitations as performance failure. Recent data show that the performance of the ossicles repair techniques are dependent on the coupling of the ossicular prosthesis to the ossicles. Furthermore, advances in the understanding of the biomechanics of the ossicles confirm the importance of the placement and linkage of surgical restoration processes. This data can be applied to middle ear implants to improve performance. Indeed, a preliminary experimental study on anatomical parts, using analysis of the vibration of the middle ear structures by laser velocimetry, allowed the investigators to define the transducer placement method and coupling method to ossicles.
Investigators wish to validate in vivo results in a pilot study on a small number of patients by comparing two surgical techniques guided by velocimetric measures.
- Being tested
- Conventional implantation, optimized implantation with laser velocimetry
- Keywords
- Middle Ear Implant, laser velocimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional implantationDevice
Usual implantation technique of a middle ear implant. The principle of the ossicular stimulator middle ear transducer MET 7000 (Middle Ear Transducer, METTM) is to directly transmit sounds on the ossicles bypassing the outer ear. Their constraint is the surgical placement of the implant.
MET 7000 system (OTOLOGICS LLC, USA) is the implant that the investigators will use for their patients. The stimulator is usually placed against the body of the anvil by simple contact in the case of sensorineural hearing loss. In the case of mixed hearing loss, the stimulator will come in contact with the bracket using a titanium clip (ossicular prosthesis used in otologic surgery for ossiculoplasties). The optimized version corresponds to the use of the conventionally used in mixed deafness and applied to neurosensory deafness art. It is screwed onto the mastoid bone, the motor is suspended in the mastoid cavity and transmits vibrations to the body of the anvil by simple contact of the transducer.
optimized implantation with laser velocimetryDevice
Also called Group benefiting from the implantation technique optimized by laser velocimetry of a middle ear implant.( the MET ossicular stimulator 7000 the company "Otologics LLC")
| Study group | Role | What they receive |
|---|---|---|
| control | Other | standard care : usual technique for implanting Receives: Device: Conventional implantation |
| laser velocimetry | Experimental | optimized implantation of laser velocimetry Receives: Device: optimized implantation with laser velocimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry
The hearing will be measured by tone and speech audiometry in silence and in noise (dB) Results will be averaged per patient.
Measured: at baseline (day 0) and 8 months
Secondary outcomes (8)
Number of surgical implantation performed for the surgical laser velocimetry optimization technique
number of surgical implantations performed in the required conditions and, if necessary, deviations will be described.
Measured: at 14 months
description of adverse events throughout the study
Measured: pre and post-operatively at day 0, at day 4, day 8 and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
Middle ear transfer function measured by laser velocimetry
measured in mm/s/Pa
Measured: pre-operatively at day 0 and then at 2, 3, 8 and 14 months.
Tone and speech audiometry in silence and in noise (dB)
Measured: Baseline at inclusion visit, day 0, and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
Change in the quality of life measured by GHSI (Glasgow Health Status Inventory) score
Changes will be described in both groups. GHSI questionnaire appreciate the impact of hearing loss on quality of life and whose translation is adapted to the French context.
Measured: day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by GBI (Glasgow Benefit Inventory) score
Changes will be described in both groups. GBI questionnaire appreciate the benefit of the port of hearing aid before surgery and the benefit of the middle ear implant after the surgery.
Measured: day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by APHAB ( Abbreviated Profile of Hearing Aid Benefit) score
Changes will be described in both groups. APHAB questionnaire is validated in subjects deaf to assess the discomfort associated with deafness in conditions of erveday life.
Measured: day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by SSQ (Speech Saptial Qualiteies) score
Changes will be described in both groups. SSQ questionnaire evaluate the binaural hearing.
Measured: day 0, and 2, 3, 5, 8 and 14 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Hearing LossStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845115
- Sponsor's protocol ID
- 2011.679
- Acronym
- IOM laser
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Surgical Optimizing of a Middle Ear Implant (MET )With Laser Velocimetry in Patients With Moderate to Severe Hearing Loss in Case of Failure of Conventional Equipment
- ClinicalTrials.gov ID
- NCT02845115
- Acronym / sponsor ID
- IOM laser / 2011.679
- Keywords
- Middle Ear Implant, laser velocimetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
The aging of the population, and greater exposure to noise, are responsible for an increased incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that has become a real public health problem. The main means of rehabilitation of this disability is represented by the apparatus of patients with conventional hearing aids. However, these hearing aids have several drawbacks that limit their profits, often abandoning the prosthesis by the patient.
Middle ear implants were developed to answer these problems. They are intended to amplify the sound signal by transmitting directly to the middle ear to compensate for the hearing loss and are indicated in case of failure or contraindication of conventional equipment. However, these middle ear implants currently have limitations as performance failure. Recent data show that the performance of the ossicles repair techniques are dependent on the coupling of the ossicular prosthesis to the ossicles. Furthermore, advances in the understanding of the biomechanics of the ossicles confirm the importance of the placement and linkage of surgical restoration processes. This data can be applied to middle ear implants to improve performance. Indeed, a preliminary experimental study on anatomical parts, using analysis of the vibration of the middle ear structures by laser velocimetry, allowed the investigators to define the transducer placement method and coupling method to ossicles.
Investigators wish to validate in vivo results in a pilot study on a small number of patients by comparing two surgical techniques guided by velocimetric measures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Other | Device: Conventional implantationstandard care : usual technique for implanting |
| laser velocimetry | Experimental | Device: optimized implantation with laser velocimetryoptimized implantation of laser velocimetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18 to 60 years;
- Having given written informed consent prior to any procedure related to the study;
- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
- Indication and IOM implantation request by the patient with a patient physically, psychologically and legally able to ask its implementation
- Average deafness to severe (mean thresholds between 40 to 90 dB) with speech discrimination> 40% to 75 dB.
Key exclusion criteria (12 listed)
- Pregnant women or likely to be during the study.
- Not affiliated with a social security scheme Patients
- Major Patients protected by provisions of the law (Public Health Code).
- Refusal of consent.
- Ongoing Participation in another study that may interfere with the proposed study (investigator assessment).
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 |
|---|---|---|
| Conventional implantationUsual implantation technique of a middle ear implant. The principle of the ossicular stimulator middle ear transducer MET 7000 (Middle Ear Transducer, METTM) is to directly transmit sounds on the ossicles bypassing the outer ear. Their constraint is the surgical placement of the implant. MET 7000 system (OTOLOGICS LLC, USA) is the implant that the investigators will use for their patients. The stimulator is usually placed against the body of the anvil by simple contact in the case of sensorineural hearing loss. In the case of mixed hearing loss, the stimulator will come in contact with the bracket using a titanium clip (ossicular prosthesis used in otologic surgery for ossiculoplasties). The optimized version corresponds to the use of the conventionally used in mixed deafness and applied to neurosensory deafness art. It is screwed onto the mastoid bone, the motor is suspended in the mastoid cavity and transmits vibrations to the body of the anvil by simple contact of the transducer. | Device | control |
| optimized implantation with laser velocimetryAlso: Group benefiting from the implantation technique optimized by laser velocimetry of a middle ear implant.( the MET ossicular stimulator 7000 the company "Otologics LLC") | Device | laser velocimetry |
Primary outcome
Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry
Time frame: at baseline (day 0) and 8 months
The hearing will be measured by tone and speech audiometry in silence and in noise (dB) Results will be averaged per patient.
8 secondary outcomes
Number of surgical implantation performed for the surgical laser velocimetry optimization technique
Time frame: at 14 months
description of adverse events throughout the study
Time frame: pre and post-operatively at day 0, at day 4, day 8 and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
Middle ear transfer function measured by laser velocimetry
Time frame: pre-operatively at day 0 and then at 2, 3, 8 and 14 months.
Tone and speech audiometry in silence and in noise (dB)
Time frame: Baseline at inclusion visit, day 0, and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
Change in the quality of life measured by GHSI (Glasgow Health Status Inventory) score
Time frame: day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by GBI (Glasgow Benefit Inventory) score
Time frame: day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by APHAB ( Abbreviated Profile of Hearing Aid Benefit) score
Time frame: day 0, and 2, 3, 5, 8 and 14 months.
Change in the quality of life measured by SSQ (Speech Saptial Qualiteies) score
Time frame: day 0, and 2, 3, 5, 8 and 14 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional implantation and optimized implantation with laser velocimetry in people with Moderate to Severe Hearing Loss and Indication of Middle Ear Implant (MET), run by Hospices Civils de Lyon.
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 10 inclusion and 12 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: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry (time frame: at baseline (day 0) and 8 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 22 Aug 2017.