Unspecified Disorder of Vestibular Function, BilateralREHAB_Rn'VNCT01839409
Biological Rhythms and Vestibular System
A study testing vestibular stimulation in people with Unspecified Disorder of Vestibular Function, Bilateral, run by University Hospital, Caen at 1 site in France.
Trial summary
The purpose of this study is to study the relationship between the vestibular system and chronobiology Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unspecified Disorder of Vestibular Function, Bilateral
- What is being tested?
- vestibular stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Apr 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No treatment changing vigilance/wakefulness
- Moderate caffein uptake (2 to 3 cups a day)
- Moderate smoker (5 cigarettes a day)
- Regular sleeping habits
Who cannot join
- Sleeping duration <6 hours or >9 hours
- Night workers
- Pregnancy
- Sleep or wakefulness disorders
- Progressive neurodegenerative disorders
- Progressive psychiatric disorders
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- Thyroid disease
- Type 1 diabetes
- Not able to practice physical activity
- Drug or alcohol addiction during the last 6 months
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 purpose of this study is to study the relationship between the vestibular system and chronobiology
Read the detailed description
The purpose of this study is to study the relationship between the vestibular system and chronobiology.
Two parts will be performed. In the first one patients with bilateral vestibular areflexia will be compared to control subjects.
In the second the effect of vestibular stimulation on circadian rhythms will be evaluated
- Being tested
- vestibular stimulation
- Keywords
- Circadian Rhythm, Exercise, Reflex, Vestibular Ocular, Postural Balance
- Medical subject headings
- Vestibular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular stimulationBehavioural
Physical activity and vestibular stimulation will be used in order to improve circadian rhythms
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Control without vestibular stimulation |
| Bilateral areflexia | No intervention | Patient with vestibular bilateral areflexia |
| Areflexia controls | No intervention | Controls for patients with vestibular bilateral areflexia, matched in sex and age |
| vestibular stimulation | Experimental | Subjects submitted to vestibular stimulation in order to improve circadian rhythms Receives: Behavioral: vestibular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions.
Gain of vestibular ocular reflex Amplitude of vestibular spinal reflex Amplitude and phase of temperature circardian rhythms
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Disorder of Vestibular Function, BilateralStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Denise, MD, PhD, Principal investigator, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839409
- Sponsor's protocol ID
- 2011-A001359-32
- Other IDs
- N° 11P03919 / N°11P03921
- Acronym
- REHAB_Rn'V
- Status last verified
- Nov 2015
- First submitted
- 22 Apr 2013
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Rhythms and Vestibular System
- ClinicalTrials.gov ID
- NCT01839409
- Acronym / sponsor ID
- REHAB_Rn'V / 2011-A001359-32
- Keywords
- Circadian Rhythm, Exercise, Reflex, Vestibular Ocular, Postural Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (estimated)
- First posted
- 24 Apr 2013 (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 purpose of this study is to study the relationship between the vestibular system and chronobiology
Detailed description
The purpose of this study is to study the relationship between the vestibular system and chronobiology.
Two parts will be performed. In the first one patients with bilateral vestibular areflexia will be compared to control subjects.
In the second the effect of vestibular stimulation on circadian rhythms will be evaluated
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Control without vestibular stimulation |
| Bilateral areflexia | No intervention | –Patient with vestibular bilateral areflexia |
| Areflexia controls | No intervention | –Controls for patients with vestibular bilateral areflexia, matched in sex and age |
| vestibular stimulation | Experimental | Behavioral: vestibular stimulationSubjects submitted to vestibular stimulation in order to improve circadian rhythms |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No treatment changing vigilance/wakefulness
- Moderate caffein uptake (2 to 3 cups a day)
- Moderate smoker (5 cigarettes a day)
- Regular sleeping habits
Key exclusion criteria (10 listed)
- Sleeping duration <6 hours or >9 hours
- Night workers
- Pregnancy
- Sleep or wakefulness disorders
- Progressive neurodegenerative 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 |
|---|---|---|
| vestibular stimulationPhysical activity and vestibular stimulation will be used in order to improve circadian rhythms | Behavioural | vestibular stimulation |
Primary outcome
Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions.
Time frame: 3 years
Gain of vestibular ocular reflex Amplitude of vestibular spinal reflex Amplitude and phase of temperature circardian rhythms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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.
Pierre Denise, MD, PhD principal investigator
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular stimulation in people with Unspecified Disorder of Vestibular Function, Bilateral, 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 4 inclusion and 10 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 3 Nov 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?
Contact Pierre Denise, MD PhD (33231068214, pierre.denise@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions. (time frame: 3 years). 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 3 Nov 2015; AzTrials last refreshed its copy on 26 Oct 2026.