Impact of Binaural Audition on Postural Performance and Orientation

Bilateral Cochlear Implants Clinical Trial

— AUDIPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201328
• Other study ID #: BOZORG GRAYELI GUIGOU UB 2015
• Status: Completed
• Phase: N/A
• First received: June 26, 2017
• Last updated: June 26, 2017
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Cochlear Implants
• Unilateral Cochlear Implants

Intervention

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.
• Videonystagmoscopic study
Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.
• Posturographies study
(stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a sensation of rotation due to a turning sound source		Baseline
Primary	Modification of posturography parameters in the presence and absence of a de turning sound source		Baseline
Primary	Time to cover a distance of 3metres in a straight line and number of steps used		Baseline