Impact of Binaural Audition on Postural Performance and Orientation

NCT ID: NCT03201328

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-02-28

Brief Summary

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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

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Conditions

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Unilateral Cochlear Implants Bilateral Cochlear Implants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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healthy subjects

Group Type ACTIVE_COMPARATOR

Audio-vestibular examination

Intervention Type OTHER

Vestibular tests (videonystagmoscopy and head video impulse test), the tonal and vocal audiogram and the localigramme to the cochlear implanted subjects. Tonal audiometry and localigramme to the healthy subjects.

Videonystagmoscopic study

Intervention Type OTHER

Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.

Posturographies study

Intervention Type OTHER

(stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.

patients with unilateral cochlear implants

Group Type EXPERIMENTAL

Audio-vestibular examination

Intervention Type OTHER

Vestibular tests (videonystagmoscopy and head video impulse test), the tonal and vocal audiogram and the localigramme to the cochlear implanted subjects. Tonal audiometry and localigramme to the healthy subjects.

Videonystagmoscopic study

Intervention Type OTHER

Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.

Posturographies study

Intervention Type OTHER

(stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.

patients with bilateral cochlear implants

Group Type EXPERIMENTAL

Audio-vestibular examination

Intervention Type OTHER

Vestibular tests (videonystagmoscopy and head video impulse test), the tonal and vocal audiogram and the localigramme to the cochlear implanted subjects. Tonal audiometry and localigramme to the healthy subjects.

Videonystagmoscopic study

Intervention Type OTHER

Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.

Posturographies study

Intervention Type OTHER

(stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.

Interventions

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Audio-vestibular examination

Vestibular tests (videonystagmoscopy and head video impulse test), the tonal and vocal audiogram and the localigramme to the cochlear implanted subjects. Tonal audiometry and localigramme to the healthy subjects.

Intervention Type OTHER

Videonystagmoscopic study

Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.

Intervention Type OTHER

Posturographies study

(stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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BOZORG GRAYELI GUIGOU UB 2015

Identifier Type: -

Identifier Source: org_study_id

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