Perception and Equilibrium After Cochlear Implantation

NCT02723695 | Unknown DMC

• 1 other identifier: 2013-A01086-39
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness

Keywords

Cochlear implant; Perception; Posture; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in visual perception of the gravitational vertical

  One year

• Change from baseline in dynamic balance control

  One year

• Change from baseline in quiet standing within a specific sound environment

  One year

• Change from baseline in vestibular function

  One year

• Change from baseline in speech recognition

  One year

Study Arms (2)

Patients

EXPERIMENTAL

Surgery (cochlear implantation)

Other: Evaluation of postural performances

Controls

ACTIVE COMPARATOR

Asymptomatic subjects

Other: Evaluation of postural performances

Interventions

Evaluation of postural performances OTHER

Postural tests

Controls; Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Profound deaf patients who are scheduled for a cochlear implantation
• Patients gave their written informed consent
• Patients are affiliated to the french social welfare

You may not qualify if:

• Disorders from the motor and/or somesthetic systems (especially the lower limbs)
• Contraindications to the scheduled functional assessments

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator

Study Sites (1)

University Hospital of Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cécile Parietti-Winkler, MD, PhD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Parietti-Winkler, MD, PhD

CONTACT

+33 383 852 032; c.parietti@chu-nancy.fr

Bettina Montaut-Verient, MD

CONTACT

+33 383 851 568; b.montaut-verient@chu-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor - Hospital Practitioner

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

FR (1)