Healthy VolunteersOTOBARNCT02565095
Interaction of Otolith Stimulation and Carotid Baroreflex in Humans
A study testing Stimulation of the carotid baroreceptors with a pressure system in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
It is well documented that a few days stay in space induces a change in the vestibular-ocular reflex reflecting a reinterpretation of sensory inputs following the disappearance of gravity. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Stimulation of the carotid baroreceptors with a pressure system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Dec 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, male and / or female aged 18-30 years
- subject affiliated to a social security scheme, agreeing to participate in the study and who provided informed consent.
Who cannot join
- who participated in a clinical trial within less than the period of exclusion from this project
- with a past or present history of heart disease, vascular, neurological, respiratory, rheumatological, metabolic or otologic.
- pregnant women (dosage beta HCG)
- having taken any medication heart, vascular, neurological, respiratory, rheumatological, metabolic or might interfere on vestibular test results during the two years preceding the experiment.
- smoking or smoking more than 5 cigarettes / day, 1 cigarette / day or 1 pipe / day
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laboratoire de Physiologie, CHU de Caen
Caen, 14000
Hervé Normand, 02.31.06.45.31
About this study
It is well documented that a few days stay in space induces a change in the vestibular-ocular reflex reflecting a reinterpretation of sensory inputs following the disappearance of gravity. If the change of eye reflexes actually the result of a reinterpretation of sensory input, the investigators should also expect to see an alteration of the vestibular-cardiovascular reflexes. The modification of these reflexes may modulate the carotid baroreflex and thus participate in the post-flight cardiovascular deconditioning.
The first objective of this project is to study the carotid baroreflex under different supine (dorsal, ventral and lateral) inducing different otolith stimulation in normal-gravity.
- Conditions
- Healthy Volunteers
- Being tested
- Stimulation of the carotid baroreceptors with a pressure system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation of the carotid baroreceptors with a pressure systemProcedure or surgery
In each decubitus, trains of stimuli 8 (-80, -60, -40, -20, 0, 10, 20 and 40 Torr), with a duration of 500 milliseconds each, will be applied using a positive and negative pressure system placed around the neck of the subject.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Baroreflex measurements | Other | Not described Receives: Procedure: Stimulation of the carotid baroreceptors with a pressure system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial flow in Common Carotid Artery (EchoDoppler)
Measurements of Common Carotid Artery Blood Flow in Cm/s
Measured: baseline
Arterial flow in Internal Carotid Artery (EchoDoppler)
Measurements of Internal Carotid Artery Blood Flow in Cm/s
Measured: Baseline
Arterial flow in External Carotid Artery (EchoDoppler)
Measurements of External Carotid Artery Blood Flow in Cm/s
Measured: Baseline
Arterial flow in Vertebral Artery (EchoDoppler)
Measurements of Vertebral Artery Blood Flow in Cm/s
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startMar 2009
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 54 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
- NCT02565095
- Sponsor's protocol ID
- 08-128
- Acronym
- OTOBAR
- Status last verified
- Sep 2015
- First submitted
- 10 Aug 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Otolith Stimulation and Carotid Baroreflex in Humans
- ClinicalTrials.gov ID
- NCT02565095
- Acronym / sponsor ID
- OTOBAR / 08-128
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2016 (estimated)
- First posted
- 1 Oct 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.
It is well documented that a few days stay in space induces a change in the vestibular-ocular reflex reflecting a reinterpretation of sensory inputs following the disappearance of gravity. If the change of eye reflexes actually the result of a reinterpretation of sensory input, the investigators should also expect to see an alteration of the vestibular-cardiovascular reflexes. The modification of these reflexes may modulate the carotid baroreflex and thus participate in the post-flight cardiovascular deconditioning.
The first objective of this project is to study the carotid baroreflex under different supine (dorsal, ventral and lateral) inducing different otolith stimulation in normal-gravity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Baroreflex measurements | Other | Procedure: Stimulation of the carotid baroreceptors with a pressure system |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers, male and / or female aged 18-30 years
- subject affiliated to a social security scheme, agreeing to participate in the study and who provided informed consent.
Key exclusion criteria (5 listed)
- who participated in a clinical trial within less than the period of exclusion from this project
- with a past or present history of heart disease, vascular, neurological, respiratory, rheumatological, metabolic or otologic.
- pregnant women (dosage beta HCG)
- having taken any medication heart, vascular, neurological, respiratory, rheumatological, metabolic or might interfere on vestibular test results during the two years preceding the experiment.
- smoking or smoking more than 5 cigarettes / day, 1 cigarette / day or 1 pipe / day
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 |
|---|---|---|
| Stimulation of the carotid baroreceptors with a pressure systemIn each decubitus, trains of stimuli 8 (-80, -60, -40, -20, 0, 10, 20 and 40 Torr), with a duration of 500 milliseconds each, will be applied using a positive and negative pressure system placed around the neck of the subject. | Procedure or surgery | Carotid Baroreflex measurements |
Primary outcome
Arterial flow in Common Carotid Artery (EchoDoppler)
Time frame: baseline
Measurements of Common Carotid Artery Blood Flow in Cm/s
Arterial flow in Internal Carotid Artery (EchoDoppler)
Time frame: Baseline
Measurements of Internal Carotid Artery Blood Flow in Cm/s
Arterial flow in External Carotid Artery (EchoDoppler)
Time frame: Baseline
Measurements of External Carotid Artery Blood Flow in Cm/s
Arterial flow in Vertebral Artery (EchoDoppler)
Time frame: Baseline
Measurements of Vertebral Artery Blood Flow in Cm/s
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 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 Stimulation of the carotid baroreceptors with a pressure system in people with Healthy Volunteers, 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 2 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: status not confirmed, as of the sponsor's last update on 1 Oct 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?
Arterial flow in Common Carotid Artery (EchoDoppler) (time frame: baseline). The study lists 4 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 1 Oct 2015.