Back to resultsBiological Rhythms and Vestibular System (REHAB_Rn'V)
Primary Purpose
Unspecified Disorder of Vestibular Function, Bilateral
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
vestibular stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Unspecified Disorder of Vestibular Function, Bilateral focused on measuring Circadian Rhythm, Exercise, Reflex, Vestibular Ocular, Postural Balance
Eligibility 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
Sites / Locations
- Umr Ucbn/Inserm U1075 CometeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
No Intervention
No Intervention
Experimental
Arm Label
control
Bilateral areflexia
Areflexia controls
vestibular stimulation
Arm Description
Control without vestibular stimulation
Patient with vestibular bilateral areflexia
Controls for patients with vestibular bilateral areflexia, matched in sex and age
Subjects submitted to vestibular stimulation in order to improve circadian rhythms
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01839409
First Posted
April 22, 2013
Last Updated
November 2, 2015
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT01839409
Brief Title
Biological Rhythms and Vestibular System
Acronym
REHAB_Rn'V
Official Title
Biological Rhythms and Vestibular System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Disorder of Vestibular Function, Bilateral
Keywords
Circadian Rhythm, Exercise, Reflex, Vestibular Ocular, Postural Balance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
Control without vestibular stimulation
Arm Title
Bilateral areflexia
Arm Type
No Intervention
Arm Description
Patient with vestibular bilateral areflexia
Arm Title
Areflexia controls
Arm Type
No Intervention
Arm Description
Controls for patients with vestibular bilateral areflexia, matched in sex and age
Arm Title
vestibular stimulation
Arm Type
Experimental
Arm Description
Subjects submitted to vestibular stimulation in order to improve circadian rhythms
Intervention Type
Behavioral
Intervention Name(s)
vestibular stimulation
Intervention Description
Physical activity and vestibular stimulation will be used in order to improve circadian rhythms
Primary Outcome Measure Information:
Title
Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions.
Description
Gain of vestibular ocular reflex Amplitude of vestibular spinal reflex Amplitude and phase of temperature circardian rhythms
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Denise, MD PhD
Phone
33231068214
Email
pierre.denise@unicaen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Denise, MD, PhD
Organizational Affiliation
University Hospital of Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umr Ucbn/Inserm U1075 Comete
City
Caen CEDEX
State/Province
Basse-Normandie
ZIP/Postal Code
14032
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Denise, MD PhD
Phone
332068214
Email
pierre.denise@unicaen.fr
12. IPD Sharing Statement
Learn more about this trial
Biological Rhythms and Vestibular System
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