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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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Brief Summary:
The purpose of this study is to study the relationship between the vestibular system and chronobiology

Condition or disease Intervention/treatment Phase
Unspecified Disorder of Vestibular Function, Bilateral Behavioral: vestibular stimulation Not Applicable

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
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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
Arms and Interventions
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Arm Intervention/treatment
No Intervention: control
Control without vestibular stimulation
No Intervention: Bilateral areflexia
Patient with vestibular bilateral areflexia
No Intervention: Areflexia controls
Controls for patients with vestibular bilateral areflexia, matched in sex and age
Experimental: vestibular stimulation
Subjects submitted to vestibular stimulation in order to improve circadian rhythms
 Behavioral: vestibular stimulation
Physical activity and vestibular stimulation will be used in order to improve circadian rhythms


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Pierre Denise, MD PhD 33231068214 pierre.denise@unicaen.fr

Locations
France
Umr Ucbn/Inserm U1075 Comete Recruiting
Caen CEDEX, Basse-Normandie, France, 14032
Contact: Pierre Denise, MD PhD    332068214    pierre.denise@unicaen.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Pierre Denise, MD, PhD University Hospital of Caen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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