Biological Rhythms and Vestibular System (REHAB_Rn'V)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2015 by University Hospital, Caen
Sponsor:
University Hospital, Caen
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01839409
First received: April 22, 2013
Last updated: November 2, 2015
Last verified: November 2015
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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: 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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839409
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | April 22, 2013 |
| Last Updated: | November 2, 2015 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
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 |
ClinicalTrials.gov processed this record on September 28, 2016