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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 November 2015
Main ID:  NCT01839409
Date of registration: 22/04/2013
Prospective Registration: No
Primary sponsor: University Hospital, Caen
Public title: Biological Rhythms and Vestibular System REHAB_Rn'V
Scientific title: Biological Rhythms and Vestibular System
Date of first enrolment: April 2013
Target sample size: 96
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT01839409
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Pierre Denise, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  University Hospital of Caen
Name:     Pierre Denise, MD PhD
Address: 
Telephone: 332068214
Email: pierre.denise@unicaen.fr
Affiliation: 
Name:     Pierre Denise, MD PhD
Address: 
Telephone: 33231068214
Email: pierre.denise@unicaen.fr
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Unspecified Disorder of Vestibular Function, Bilateral
Intervention(s)
Behavioral: vestibular stimulation
Primary Outcome(s)
Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions. [Time Frame: 3 years]
Secondary Outcome(s)
Secondary ID(s)
N° 11P03919 / N°11P03921
2011-A001359-32
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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