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Perception and Equilibrium After Cochlear Implantation (ORIENTIMPLANT)

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

Deafness

Treatments

Other: Evaluation of postural performances

Study type

Interventional

Funder types

Other

Identifiers

NCT02723695
2013-A01086-39

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Patients
Experimental group
Description:
Surgery (cochlear implantation)
Treatment:
Other: Evaluation of postural performances
Controls
Active Comparator group
Description:
Asymptomatic subjects
Treatment:
Other: Evaluation of postural performances

Trial contacts and locations

1

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Central trial contact

Cécile Parietti-Winkler, MD, PhD; Bettina Montaut-Verient, MD

Data sourced from clinicaltrials.gov

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