Perception and Equilibrium After Cochlear Implantation

NCT ID: NCT02723695

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-03-31

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.

Detailed Description

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Conditions

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Deafness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients

Surgery (cochlear implantation)

Group Type EXPERIMENTAL

Evaluation of postural performances

Intervention Type OTHER

Postural tests

Controls

Asymptomatic subjects

Group Type ACTIVE_COMPARATOR

Evaluation of postural performances

Intervention Type OTHER

Postural tests

Interventions

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Evaluation of postural performances

Postural tests

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Lorraine

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Cecile PARIETTI-WINKLER

University Professor - Hospital Practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cécile Parietti-Winkler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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University Hospital of Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile Parietti-Winkler, MD, PhD

Role: CONTACT

+33 383 852 032

Bettina Montaut-Verient, MD

Role: CONTACT

+33 383 851 568

Facility Contacts

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Cécile Parietti-Winkler, MD, PhD

Role: primary

+33 383 852 032

Bettina Montaut-Verient, MD

Role: backup

+33 383 851 568

Other Identifiers

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2013-A01086-39

Identifier Type: -

Identifier Source: org_study_id

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