Impact of Binaural Audition on Postural Performance and Orientation

Not Applicable

Completed

• Conditions: Unilateral Cochlear Implants; Bilateral Cochlear Implants
• Interventions: Other: Audio-vestibular examination; Other: Videonystagmoscopic study; Other: Posturographies study

• Registration Number: NCT03201328
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

This is a prospective research study talking place at University hospital of Dijon and requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants and 10 patients with bilateral cochlear implants to carry out:

* an audio-vestibular examination,

* a videonystagmoscopic study,

* a posturography study and

* a movement study. The aim of the study is to evaluate the impact of binaural audition on postural performance and orientation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-08
• Study Completion: 2017-02
• Status Verified: 2017-06
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Study First Posted: 2017-06-28
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients who have provided written consent
• Patients with health insurance cover
• Age between 18 and 75 years old
• For subjects with implants: unilateral or bilateral cochlear implants for more than one year
• For healthy subjects: absence of known audio-vestibular disorders (deafness, vertigo)

Exclusion Criteria

• Patients dependent on an aid to move around (cane, wheelchair, crutch, ...)
• Patients under guardianship
• Pregnant women
• Disability interfering with understanding or carrying out instructions
• Associated sensory or motor disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy subjects	Posturographies study	-
healthy subjects	Audio-vestibular examination	-
patients with unilateral cochlear implants	Audio-vestibular examination	-
patients with bilateral cochlear implants	Audio-vestibular examination	-
healthy subjects	Videonystagmoscopic study	-
patients with unilateral cochlear implants	Videonystagmoscopic study	-
patients with bilateral cochlear implants	Videonystagmoscopic study	-
patients with unilateral cochlear implants	Posturographies study	-
patients with bilateral cochlear implants	Posturographies study	-

Primary Outcome Measures

Name	Time	Method
Modification of posturography parameters in the presence and absence of a de turning sound source	Baseline
Time to cover a distance of 3metres in a straight line and number of steps used	Baseline
Presence of a sensation of rotation due to a turning sound source	Baseline

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France