ORIENTIMPLANT: Perception and Equilibrium After Cochlear Implantation

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02723695

Collaborator

University of Lorraine (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deafness	Other: Evaluation of postural performances	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Assessment of Perceptual and Postural Performances Following a Cochlear Implantation

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients Surgery (cochlear implantation)	Other: Evaluation of postural performances Postural tests
Active Comparator: Controls Asymptomatic subjects	Other: Evaluation of postural performances Postural tests

Arm

Intervention/Treatment

Experimental: Patients

Surgery (cochlear implantation)

Other: Evaluation of postural performances

Postural tests

Active Comparator: Controls

Asymptomatic subjects

Other: Evaluation of postural performances

Postural tests

Outcome Measures

Primary Outcome Measures

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

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 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 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 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Nancy	Nancy		France	54000

Sponsors and Collaborators

Central Hospital, Nancy, France
University of Lorraine

Investigators

Principal Investigator: Cécile Parietti-Winkler, MD, PhD, Central Hospital, Nancy, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cecile PARIETTI-WINKLER, University Professor - Hospital Practitioner, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT02723695

Other Study ID Numbers:

2013-A01086-39

First Posted:

Mar 30, 2016

Last Update Posted:

Mar 30, 2016

Last Verified:

Mar 1, 2016

Keywords provided by Cecile PARIETTI-WINKLER, University Professor - Hospital Practitioner, Central Hospital, Nancy, France

Additional relevant MeSH terms:

Deafness

Study Results

No Results Posted as of Mar 30, 2016