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Biological Rhythms and Vestibular System (REHAB_Rn'V)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by University Hospital, Caen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01839409
First Posted: April 24, 2013
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Caen
  Purpose
The purpose of this study is to study the relationship between the vestibular system and chronobiology

Condition Intervention
Unspecified Disorder of Vestibular Function, Bilateral Behavioral: vestibular stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Biological Rhythms and Vestibular System

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 96
Study Start Date: April 2013
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Information from the National Library of Medicine

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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
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

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 Submitted: April 22, 2013
First Posted: April 24, 2013
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