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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

Tracking Information
First Submitted Date  ICMJE March 24, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date March 30, 2016
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • 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.
  • 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).
  • 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]
  • 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)
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perception and Equilibrium After Cochlear Implantation
Official Title  ICMJE Assessment of Perceptual and Postural Performances Following a Cochlear Implantation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Deafness
Intervention  ICMJE Other: Evaluation of postural performances
Postural tests
Study Arms  ICMJE
  • Experimental: Patients
    Surgery (cochlear implantation)
    Intervention: Other: Evaluation of postural performances
  • Active Comparator: Controls
    Asymptomatic subjects
    Intervention: Other: Evaluation of postural performances
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 24, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02723695
Other Study ID Numbers  ICMJE 2013-A01086-39
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE University of Lorraine
Investigators  ICMJE
Principal Investigator: Cécile Parietti-Winkler, MD, PhD Central Hospital, Nancy, France
PRS Account Central Hospital, Nancy, France
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP