- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518074
Hearing and Vestibular Interactions in the Collection of Own Body and Sense of Self (AUDIOSELF)
August 6, 2015 updated by: University Hospital, Caen
The investigators objective is twofold. Investigators propose to study how the vestibular and auditory information interact in the construction of coherence between the staff and extrapersonal space.
Furthermore, investigators want to investigate whether, even in the absence of gravity, the auditory spatial information allocentric provide a framework for spatial reference.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Basse-Normandie
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Caen CEDEX, Basse-Normandie, France, 14032
- Recruiting
- Umr Ucbn/Inserm U1075 Comete
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers (men or women)
- Aged between 18-65 years
- Affiliates to a social security system or, for non-residents in France, holder of a European Health Insurance Card European (EHIC European Health Insurance Card)
- Who are willing to take part in the study,
- Who gave written informed consent,
- Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects.
Exclusion Criteria:
- People who took part in a biomedical research protocol for which the exclusion period is complete,
- People with psychotic disorders and / or depression,
- People receiving psychotropic medication,
- People with alcohol dependence or illicit substances,
- People with visual acuity less than 8 / 10ths corrected by lenses or glasses,
- People with a significant decrease in hearing,
- pregnant women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: HEARING AND VESTIBULAR INTERACTIONS
Hearing and Vestibular Interactions during two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity).
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in two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Responses to the questionnaire "Botvinick Cohen" on the sensations of the body out experiments
Time Frame: baseline
|
baseline
|
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Answers on the location of auditory stimuli
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Anticipated)
November 1, 2017
Study Registration Dates
First Submitted
July 22, 2015
First Submitted That Met QC Criteria
August 6, 2015
First Posted (Estimate)
August 7, 2015
Study Record Updates
Last Update Posted (Estimate)
August 7, 2015
Last Update Submitted That Met QC Criteria
August 6, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13-070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.