Biological Rhythms and Vestibular System

Unspecified Disorder of Vestibular Function, Bilateral Clinical Trial

— REHAB_Rn'V  

Official title:

Biological Rhythms and Vestibular System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01839409
• Other study ID #: 2011-A001359-32
• Secondary ID: N° 11P03919 / N°
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2013
• Last updated: November 2, 2015
• Start date: April 2013

Study information

• Verified date: November 2015
• Source: University Hospital, Caen
• Contact: Pierre Denise, MD PhD
• Phone: 33231068214
• Email: pierre.denise[@]unicaen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the relationship between the vestibular system and chronobiology

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Unspecified Disorder of Vestibular Function, Bilateral
• Vestibular Diseases

Intervention

Behavioral:
• vestibular stimulation
Physical activity and vestibular stimulation will be used in order to improve circadian rhythms

Locations

Country	Name	City	State
France	Umr Ucbn/Inserm U1075 Comete	Caen CEDEX	Basse-Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years	No