Impact of Binaural Audition on Postural Performance and Orientation (AUDIPIC)

Prospective, Single Centre Cohort Study on the Impact of Binaural Audition on Postural Performance and Orientation in Healthy Subjects and Patients With Cochlear Implants.

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.

Study Overview

• Status: Completed
• Conditions: Unilateral Cochlear Implants; Bilateral Cochlear Implants
• Intervention / Treatment: Other: Audio-vestibular examination; Other: Videonystagmoscopic study; Other: Posturographies study

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthy subjects	Other: 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.; Other: Videonystagmoscopic study; Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.; Other: Posturographies study; (stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.
Experimental: patients with unilateral cochlear implants	Other: 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.; Other: Videonystagmoscopic study; Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.; Other: Posturographies study; (stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.
Experimental: patients with bilateral cochlear implants	Other: 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.; Other: Videonystagmoscopic study; Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.; Other: Posturographies study; (stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of a sensation of rotation due to a turning sound source	Baseline
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BOZORG GRAYELI GUIGOU UB 2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No