Deafness
Conditions
Keywords
Cochlear implant, Perception, Posture, Quality of life
Brief 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 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.
Interventions
OTHEREvaluation of postural performances
Postural tests
Sponsors
University of Lorraine
Central Hospital, Nancy, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in postural perception of the gravitational vertical | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in dynamic balance control | One year | 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). |
| Change from baseline in quiet standing within a specific sound environment | One year | 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 \[quiet - implant OFF, quiet - implant ON, white noise (70 dB) - implant ON, the semantic content (70 dB) - implant OFF\] |
| Change from baseline in vestibular function | One year | 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) |
| Change from baseline in visual perception of the gravitational vertical | 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 rod (in degree) over 20 trials. |
| Change from baseline in quality of life | One year | 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). |
| Change from baseline in dizziness | One year | 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). |
| Change from baseline in speech recognition | One year | 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. |
Countries
France
Contacts
Primary ContactCécile Parietti-Winkler, MD, PhD
Backup ContactBettina Montaut-Verient, MD
Outcome results
None listed