NCT03201328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 26, 2017

Last Update Submit

June 26, 2017

Conditions

Unilateral Cochlear ImplantsBilateral Cochlear Implants

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

healthy subjects

ACTIVE COMPARATOR
Other: Audio-vestibular examinationOther: Videonystagmoscopic studyOther: Posturographies study

patients with unilateral cochlear implants

EXPERIMENTAL
Other: Audio-vestibular examinationOther: Videonystagmoscopic studyOther: Posturographies study

patients with bilateral cochlear implants

EXPERIMENTAL
Other: Audio-vestibular examinationOther: Videonystagmoscopic studyOther: Posturographies study

Interventions

Audio-vestibular examinationOTHER

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.

healthy subjectspatients with bilateral cochlear implantspatients with unilateral cochlear implants
Videonystagmoscopic studyOTHER

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

healthy subjectspatients with bilateral cochlear implantspatients with unilateral cochlear implants
Posturographies studyOTHER

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

healthy subjectspatients with bilateral cochlear implantspatients with unilateral cochlear implants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 28, 2017

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

February 1, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

FR(1)