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| Name | Class |
|---|---|
| University of Lorraine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Surgery (cochlear implantation) |
|
| Controls | Active Comparator | Asymptomatic subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of postural performances | Other | Postural tests |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile Parietti-Winkler, MD, PhD | Contact | +33 383 852 032 | c.parietti@chu-nancy.fr | |
| Bettina Montaut-Verient, MD | Contact | +33 383 851 568 | b.montaut-verient@chu-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cécile Parietti-Winkler, MD, PhD | Central Hospital, Nancy, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Nancy | Recruiting | Nancy | 54000 | France |
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| ID | Term |
|---|---|
| D003638 | Deafness |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| 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). |
| 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] | 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) | 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. | 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). | 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). | One year |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |