HealthyAUDIOSELFNCT02518074
Hearing and Vestibular Interactions in the Collection of Own Body and Sense of Self
A study testing Hearing and Vestibular Interactions in people with Healthy, run by University Hospital, Caen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hearing and Vestibular Interactions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Umr Ucbn/Inserm U1075 Comete
Caen, Basse-Normandie, 14032
Pierre Denise, MD PhD, 332068214, pierre.denise@unicaen.fr
About this study
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.
- Conditions
- Healthy
- Being tested
- Hearing and Vestibular Interactions
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing and Vestibular InteractionsOther
Also called in two body positions and three gravity conditions
in two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity).
| Study group | Role | What they receive |
|---|---|---|
| HEARING AND VESTIBULAR INTERACTIONS | Other | Hearing and Vestibular Interactions during two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity). Receives: Other: Hearing and Vestibular Interactions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responses to the questionnaire "Botvinick Cohen" on the sensations of the body out experiments
Measured: baseline
Answers on the location of auditory stimuli
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startOct 2013
- Primary completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518074
- Sponsor's protocol ID
- 13-070
- Acronym
- AUDIOSELF
- Status last verified
- Aug 2015
- First submitted
- 22 Jul 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing and Vestibular Interactions in the Collection of Own Body and Sense of Self
- ClinicalTrials.gov ID
- NCT02518074
- Acronym / sponsor ID
- AUDIOSELF / 13-070
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2017 (estimated)
- First posted
- 7 Aug 2015 (estimated)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEARING AND VESTIBULAR INTERACTIONS | Other | Other: Hearing and Vestibular InteractionsHearing and Vestibular Interactions during two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Hearing and Vestibular InteractionsAlso: in two body positions and three gravity conditionsin two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity). | Other | HEARING AND VESTIBULAR INTERACTIONS |
Primary outcome
Responses to the questionnaire "Botvinick Cohen" on the sensations of the body out experiments
Time frame: baseline
Answers on the location of auditory stimuli
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing and Vestibular Interactions in people with Healthy, run by University Hospital, Caen 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responses to the questionnaire "Botvinick Cohen" on the sensations of the body out experiments (time frame: baseline). The study lists 2 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 7 Aug 2015.