Perception and Equilibrium After Cochlear Implantation

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Perceptual and Postural Performances Following a Cochlear Implantation

Conditions
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Deafness

Intervention / Treatment
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* Other: Evaluation of postural performances


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Profound deaf patients who are scheduled for a cochlear implantation Patients gave their written informed consent Patients are affiliated to the french social welfare Exclusion Criteria: Disorders from the motor and/or somesthetic systems (especially the lower limbs) Contraindications to the scheduled functional assessments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Surgery (cochlear implantation) | Other: Evaluation of postural performances<br>* Postural tests<br>|
| Active Comparator: Controls<br>Asymptomatic subjects | Other: Evaluation of postural performances<br>* Postural tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perception, Cochlear implant, Posture, Quality of life