Suspended
REHAB_Rn'VBiological Rhythms and Vestibular System
What is being tested
vestibular stimulation
Behavioral
Who is being recruted
Behavior+3
+ Ear Diseases
+ Labyrinth Diseases
Over 20 Years
+14 Eligibility Criteria
How is the trial designed
Basic Science Study
Interventional
Study Start: April 2013
Summary
Principal SponsorUniversity Hospital, Caen
Study ContactPierre Denise, MD PhDMore contacts
Last updated: November 3, 2015Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.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
Principal SponsorUniversity Hospital, Caen
Study ContactPierre Denise, MD PhDMore contacts
Last updated: November 3, 2015Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
96 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorEar DiseasesLabyrinth DiseasesOtorhinolaryngologic DiseasesMotor ActivityVestibular Diseases
Criteria
4 inclusion criteria required to participate
Moderate caffein uptake (2 to 3 cups a day)
Moderate smoker (5 cigarettes a day)
No treatment changing vigilance/wakefulness
Regular sleeping habits
10 exclusion criteria prevent from participating
Drug or alcohol addiction during the last 6 months
Night workers
Not able to practice physical activity
Pregnancy
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
No InterventionControl without vestibular stimulation
Group II
No InterventionPatient with vestibular bilateral areflexia
Group III
No InterventionControls for patients with vestibular bilateral areflexia, matched in sex and age
Group IV
ExperimentalSubjects submitted to vestibular stimulation in order to improve circadian rhythms
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center