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Completed

NCT Number: NCT03201328

Impact of Binaural Audition on Postural Performance and Orientation

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.

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Key information

Conditions

Unilateral Cochlear Implants Bilateral Cochlear Implants

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audio-vestibular examination

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

Other

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

Posturographies study

Other

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

Primary outcomes

  1. Presence of a sensation of rotation due to a turning sound source

    Time frame: Baseline

  2. Modification of posturography parameters in the presence and absence of a de turning sound source

    Time frame: Baseline

  3. Time to cover a distance of 3metres in a straight line and number of steps used

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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.

Acronym: AUDIPIC

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 28, 2017
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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