Unilateral Cochlear ImplantsAUDIPICNCT03201328
Impact of Binaural Audition on Postural Performance and Orientation
A study testing Audio-vestibular examination, Videonystagmoscopic study and Posturographies study in people with Unilateral Cochlear Implants and Bilateral Cochlear Implants, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Cochlear Implants, Bilateral Cochlear Implants
- What is being tested?
- Audio-vestibular examination, Videonystagmoscopic study and Posturographies study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Audio-vestibular examination, Videonystagmoscopic study, Posturographies study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Videonystagmoscopic studyOther
Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.
Posturographies studyOther
(stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Active comparator | Not described Receives: Other: Audio-vestibular examination; Other: Videonystagmoscopic study; Other: Posturographies study |
| patients with unilateral cochlear implants | Experimental | Not described Receives: Other: Audio-vestibular examination; Other: Videonystagmoscopic study; Other: Posturographies study |
| patients with bilateral cochlear implants | Experimental | Not described Receives: Other: Audio-vestibular examination; Other: Videonystagmoscopic study; Other: Posturographies study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a sensation of rotation due to a turning sound source
Measured: Baseline
Modification of posturography parameters in the presence and absence of a de turning sound source
Measured: Baseline
Time to cover a distance of 3metres in a straight line and number of steps used
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startFeb 2016
- Primary completionAug 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201328
- Sponsor's protocol ID
- BOZORG GRAYELI GUIGOU UB 2015
- Acronym
- AUDIPIC
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03201328
- Acronym / sponsor ID
- AUDIPIC / BOZORG GRAYELI GUIGOU UB 2015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Active comparator | Other: Audio-vestibular examination, Other: Videonystagmoscopic study, Other: Posturographies study |
| patients with unilateral cochlear implants | Experimental | Other: Audio-vestibular examination, Other: Videonystagmoscopic study, Other: Posturographies study |
| patients with bilateral cochlear implants | Experimental | Other: Audio-vestibular examination, Other: Videonystagmoscopic study, Other: Posturographies study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-vestibular examinationVestibular 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 | healthy subjects, patients with bilateral cochlear implants, patients with unilateral cochlear implants |
| Videonystagmoscopic studyRotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination. | Other | healthy subjects, patients with bilateral cochlear implants, patients with unilateral cochlear implants |
| Posturographies study(stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination. | Other | healthy subjects, patients with bilateral cochlear implants, patients with unilateral cochlear implants |
Primary outcome
Presence of a sensation of rotation due to a turning sound source
Time frame: Baseline
Modification of posturography parameters in the presence and absence of a de turning sound source
Time frame: Baseline
Time to cover a distance of 3metres in a straight line and number of steps used
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
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Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio-vestibular examination, Videonystagmoscopic study and Posturographies study in people with Unilateral Cochlear Implants and Bilateral Cochlear Implants, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a sensation of rotation due to a turning sound source (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.