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Perception and Equilibrium After Cochlear Implantation (ORIENTIMPLANT)

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ClinicalTrials.gov Identifier: NCT02723695
Recruitment Status : Unknown
Verified March 2016 by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from baseline in postural perception of the gravitational vertical [ Time Frame: 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 :
  1. Change from baseline in visual perception of the gravitational vertical [ Time Frame: 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.


  2. Change from baseline in dynamic balance control [ Time Frame: 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).


  3. Change from baseline in quiet standing within a specific sound environment [ Time Frame: 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]


  4. Change from baseline in vestibular function [ Time Frame: 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)


  5. Change from baseline in speech recognition [ Time Frame: 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.


  6. Change from baseline in quality of life [ Time Frame: 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).


  7. Change from baseline in dizziness [ Time Frame: 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723695


Contacts
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Contact: Cécile Parietti-Winkler, MD, PhD +33 383 852 032 c.parietti@chu-nancy.fr
Contact: Bettina Montaut-Verient, MD +33 383 851 568 b.montaut-verient@chu-nancy.fr

Locations
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France
University Hospital of Nancy Recruiting
Nancy, France, 54000
Contact: Cécile Parietti-Winkler, MD, PhD    +33 383 852 032    c.parietti@chu-nancy.fr   
Contact: Bettina Montaut-Verient, MD    +33 383 851 568    b.montaut-verient@chu-nancy.fr   
Principal Investigator: Cécile Parietti-Winkler, MD, PhD         
Sub-Investigator: Philippe Perrin, MD, PhD         
Sub-Investigator: Bettina Montaut-Verient, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
University of Lorraine
Investigators
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Principal Investigator: Cécile Parietti-Winkler, MD, PhD Central Hospital, Nancy, France

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Responsible Party: Cecile PARIETTI-WINKLER, University Professor - Hospital Practitioner, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02723695     History of Changes
Other Study ID Numbers: 2013-A01086-39
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Keywords provided by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France:
Cochlear implant
Perception
Posture
Quality of life
Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms