Perception and Equilibrium After Cochlear Implantation (ORIENTIMPLANT)

Assessment of Perceptual and Postural Performances Following a Cochlear Implantation

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.

Study Overview

• Status: Unknown
• Conditions: Deafness
• Intervention / Treatment: Other: Evaluation of postural performances

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cécile Parietti-Winkler, MD, PhD; Phone Number: +33 383 852 032; Email: c.parietti@chu-nancy.fr
• Study Contact Backup: Name: Bettina Montaut-Verient, MD; Phone Number: +33 383 851 568; Email: b.montaut-verient@chu-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • University Hospital Of Nancy
    • Contact: Cécile Parietti-Winkler, MD, PhD; Phone Number: +33 383 852 032; Email: c.parietti@chu-nancy.fr
    • Sub-Investigator: Philippe Perrin, MD, PhD
    • Contact: Bettina Montaut-Verient, MD; Phone Number: +33 383 851 568; Email: b.montaut-verient@chu-nancy.fr
    • Principal Investigator: Cécile Parietti-Winkler, MD, PhD
    • Sub-Investigator: Bettina Montaut-Verient, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in visual 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 rod (in degree) over 20 trials.	One year
Change from baseline in dynamic balance control	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).	One year
Change from baseline in quiet standing within a specific sound environment	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]	One year
Change from baseline in vestibular function	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)	One year
Change from baseline in speech recognition	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.	One year
Change from baseline in quality of life	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).	One year
Change from baseline in dizziness	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).	One year

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University of Lorraine
• Investigators: Principal Investigator: Cécile Parietti-Winkler, MD, PhD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 24, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Quality of life; Posture; Cochlear implant; Perception
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 2013-A01086-39