Skip to main content
Clinical Trials/NCT02723695
NCT02723695
Unknown
Not Applicable

Assessment of Perceptual and Postural Performances Following a Cochlear Implantation

Central Hospital, Nancy, France1 site in 1 country50 target enrollmentMarch 2014
ConditionsDeafness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deafness
Sponsor
Central Hospital, Nancy, France
Enrollment
50
Locations
1
Primary Endpoint
Change from baseline in postural perception of the gravitational vertical
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
March 2019
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Cecile PARIETTI-WINKLER

University Professor - Hospital Practitioner

Central Hospital, Nancy, France

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

Outcomes

Primary Outcomes

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 Outcomes

  • Change from baseline in dynamic balance control(One year)
  • Change from baseline in vestibular function(One year)
  • Change from baseline in dizziness(One year)
  • Change from baseline in quiet standing within a specific sound environment(One year)
  • Change from baseline in speech recognition(One year)
  • Change from baseline in quality of life(One year)
  • Change from baseline in visual perception of the gravitational vertical(One year)

Study Sites (1)

Loading locations...

Similar Trials