DeafnessORIENTIMPLANTNCT02723695
Perception and Equilibrium After Cochlear Implantation
A study testing Evaluation of postural performances in people with Deafness, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Evaluation of postural performances
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Mar 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Profound deaf patients who are scheduled for a cochlear implantation
- Patients gave their written informed consent
- Patients are affiliated to the french social welfare
Who cannot join
- Disorders from the motor and/or somesthetic systems (especially the lower limbs)
- Contraindications to the scheduled functional assessments
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Nancy
Nancy, 54000
Cécile Parietti-Winkler, MD, PhD, +33 383 852 032, c.parietti@chu-nancy.fr
Bettina Montaut-Verient, MD, +33 383 851 568, b.montaut-verient@chu-nancy.fr
About this study
Official title: Assessment of Perceptual and Postural Performances Following a Cochlear Implantation
The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.
The usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture.
- Conditions
- Deafness
- Being tested
- Evaluation of postural performances
- Keywords
- Cochlear implant, Perception, Posture, Quality of life
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of postural performancesOther
Postural tests
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Surgery (cochlear implantation) Receives: Other: Evaluation of postural performances |
| Controls | Active comparator | Asymptomatic subjects Receives: Other: Evaluation of postural performances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in postural perception of the gravitational vertical
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).
The measure is the average difference between the gravitational vertical and the tilt of the platform (in degree) over 20 trials.
Measured: One year
Secondary outcomes (7)
Change from baseline in visual perception of the gravitational vertical
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).
The measure is the average difference between the gravitational vertical and the tilt of the rod (in degree) over 20 trials.
Measured: One year
Change from baseline in dynamic balance control
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).
The composite equilibrium (%) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA).
Measured: One year
Change from baseline in quiet standing within a specific sound environment
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).
The area covered by the centre of pressure in static posturography (eyes open and eyes closed) is calculated during trials within a specific and controled sound environment [quiet - implant OFF, quiet - implant ON, white noise (70 dB) - implant ON, the semantic content (70 dB) - implant OFF]
Measured: One year
Change from baseline in vestibular function
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).
Vestibular function is quantified by means of videonystagmography (pendular and caloric tests)
Measured: One year
Change from baseline in speech recognition
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).
Speech recognition (in %) is quantified with cochlear phonemic lists of Lafon at 70 dB with and without leep reading.
Measured: One year
Change from baseline in quality of life
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).
Score of the quality of life (QoL) questionnaire (WHOQOL-BREF).
Measured: One year
Change from baseline in dizziness
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).
Self-rated score of the Dizziness Handicap Inventory (DHI).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Principal investigator, Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
- Investigators
- Cécile Parietti-Winkler, MD, PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723695
- Sponsor's protocol ID
- 2013-A01086-39
- Acronym
- ORIENTIMPLANT
- Status last verified
- Mar 2016
- First submitted
- 24 Mar 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Perceptual and Postural Performances Following a Cochlear Implantation
- ClinicalTrials.gov ID
- NCT02723695
- Acronym / sponsor ID
- ORIENTIMPLANT / 2013-A01086-39
- Conditions
- Deafness
- Keywords
- Cochlear implant, Perception, Posture, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- Mar 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 30 Mar 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 cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.
The usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Evaluation of postural performancesSurgery (cochlear implantation) |
| Controls | Active comparator | Other: Evaluation of postural performancesAsymptomatic subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Profound deaf patients who are scheduled for a cochlear implantation
- Patients gave their written informed consent
- Patients are affiliated to the french social welfare
Key exclusion criteria (2 listed)
- Disorders from the motor and/or somesthetic systems (especially the lower limbs)
- Contraindications to the scheduled functional assessments
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 |
|---|---|---|
| Evaluation of postural performancesPostural tests | Other | Controls, Patients |
Primary outcome
Change from baseline in postural perception of the gravitational vertical
Time frame: One year
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery). The measure is the average difference between the gravitational vertical and the tilt of the platform (in degree) over 20 trials.
7 secondary outcomes
Change from baseline in visual perception of the gravitational vertical
Time frame: One year
Change from baseline in dynamic balance control
Time frame: One year
Change from baseline in quiet standing within a specific sound environment
Time frame: One year
Change from baseline in vestibular function
Time frame: One year
Change from baseline in speech recognition
Time frame: One year
Change from baseline in quality of life
Time frame: One year
Change from baseline in dizziness
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
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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.
Cécile Parietti-Winkler, MD, PhD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of postural performances in people with Deafness, run by Central Hospital, Nancy, France at 1 site in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile Parietti-Winkler, MD, PhD (+33 383 852 032, c.parietti@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in postural perception of the gravitational vertical (time frame: One year). 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 30 Mar 2016.