Perception and Equilibrium After Cochlear Implantation

Not Applicable

• Conditions: Deafness
• Interventions: Other: Evaluation of postural performances

• Registration Number: NCT02723695
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2016-03
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-24
• Last Update Submitted: 2016-03-24
• Study First Posted: 2016-03-30
• Last Update Posted: 2016-03-30
• Primary Completion: 2018-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Controls	Evaluation of postural performances	Asymptomatic subjects
Patients	Evaluation of postural performances	Surgery (cochlear implantation)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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.
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 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.

Trial Locations

Locations (1)

University Hospital of Nancy; 🇫🇷 Nancy, France