Biological Rhythms and Vestibular System (REHAB_Rn'V)
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ClinicalTrials.gov Identifier: NCT01839409 |
Recruitment Status
: Unknown
Verified November 2015 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted
: April 24, 2013
Last Update Posted
: November 3, 2015
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Condition or disease | Intervention/treatment | Phase |
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Unspecified Disorder of Vestibular Function, Bilateral | Behavioral: vestibular stimulation | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 96 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Biological Rhythms and Vestibular System |
Study Start Date : | April 2013 |
Estimated Primary Completion Date : | April 2016 |
Arm | Intervention/treatment |
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No Intervention: control
Control without vestibular stimulation
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No Intervention: Bilateral areflexia
Patient with vestibular bilateral areflexia
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No Intervention: Areflexia controls
Controls for patients with vestibular bilateral areflexia, matched in sex and age
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Experimental: vestibular stimulation
Subjects submitted to vestibular stimulation in order to improve circadian rhythms
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Behavioral: vestibular stimulation
Physical activity and vestibular stimulation will be used in order to improve circadian rhythms
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- 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

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- No treatment changing vigilance/wakefulness
- Moderate caffein uptake (2 to 3 cups a day)
- Moderate smoker (5 cigarettes a day)
- Regular sleeping habits
Exclusion Criteria:
- Sleeping duration <6 hours or >9 hours
- Night workers
- Pregnancy
- Sleep or wakefulness disorders
- Progressive neurodegenerative disorders
- Progressive psychiatric disorders
- Thyroid disease
- Type 1 diabetes
- Not able to practice physical activity
- Drug or alcohol addiction during the last 6 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839409
Contact: Pierre Denise, MD PhD | 33231068214 | pierre.denise@unicaen.fr |
France | |
Umr Ucbn/Inserm U1075 Comete | Recruiting |
Caen CEDEX, Basse-Normandie, France, 14032 | |
Contact: Pierre Denise, MD PhD 332068214 pierre.denise@unicaen.fr |
Principal Investigator: | Pierre Denise, MD, PhD | University Hospital of Caen |
Responsible Party: | University Hospital, Caen |
ClinicalTrials.gov Identifier: | NCT01839409 History of Changes |
Other Study ID Numbers: |
2011-A001359-32 N° 11P03919 / N°11P03921 ( Other Grant/Funding Number: CRBN ) |
First Posted: | April 24, 2013 Key Record Dates |
Last Update Posted: | November 3, 2015 |
Last Verified: | November 2015 |
Keywords provided by University Hospital, Caen:
Circadian Rhythm Exercise Reflex, Vestibular Ocular Postural Balance |
Additional relevant MeSH terms:
Vestibular Diseases Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases |