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Perception and Equilibrium After Cochlear Implantation (ORIENTIMPLANT)

Primary Purpose

Deafness

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of postural performances
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Deafness focused on measuring Cochlear implant, Perception, Posture, Quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients

Controls

Arm Description

Surgery (cochlear implantation)

Asymptomatic subjects

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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]
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)
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.
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).
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).

Full Information

First Posted
March 24, 2016
Last Updated
March 24, 2016
Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02723695
Brief Title
Perception and Equilibrium After Cochlear Implantation
Acronym
ORIENTIMPLANT
Official Title
Assessment of Perceptual and Postural Performances Following a Cochlear Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness
Keywords
Cochlear implant, Perception, Posture, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Surgery (cochlear implantation)
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Asymptomatic subjects
Intervention Type
Other
Intervention Name(s)
Evaluation of postural performances
Intervention Description
Postural tests
Primary Outcome Measure Information:
Title
Change from baseline in postural perception of the gravitational vertical
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Change from baseline in visual perception of the gravitational vertical
Description
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.
Time Frame
One year
Title
Change from baseline in dynamic balance control
Description
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).
Time Frame
One year
Title
Change from baseline in quiet standing within a specific sound environment
Description
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]
Time Frame
One year
Title
Change from baseline in vestibular function
Description
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)
Time Frame
One year
Title
Change from baseline in speech recognition
Description
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.
Time Frame
One year
Title
Change from baseline in quality of life
Description
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).
Time Frame
One year
Title
Change from baseline in dizziness
Description
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).
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile Parietti-Winkler, MD, PhD
Phone
+33 383 852 032
Email
c.parietti@chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bettina Montaut-Verient, MD
Phone
+33 383 851 568
Email
b.montaut-verient@chu-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile Parietti-Winkler, MD, PhD
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Parietti-Winkler, MD, PhD
Phone
+33 383 852 032
Email
c.parietti@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Bettina Montaut-Verient, MD
Phone
+33 383 851 568
Email
b.montaut-verient@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Cécile Parietti-Winkler, MD, PhD
First Name & Middle Initial & Last Name & Degree
Philippe Perrin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bettina Montaut-Verient, MD

12. IPD Sharing Statement

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Perception and Equilibrium After Cochlear Implantation

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