REHAB_Rn'V: Biological Rhythms and Vestibular System

Sponsor

University Hospital, Caen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01839409

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Unspecified Disorder of Vestibular Function, Bilateral	Behavioral: vestibular stimulation	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Biological Rhythms and Vestibular System

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions. [3 years]
Gain of vestibular ocular reflex Amplitude of vestibular spinal reflex Amplitude and phase of temperature circardian rhythms

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Umr Ucbn/Inserm U1075 Comete	Caen CEDEX	Basse-Normandie	France	14032

Sponsors and Collaborators

University Hospital, Caen

Investigators

Principal Investigator: Pierre Denise, MD, PhD, University Hospital of Caen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT01839409

Other Study ID Numbers:

2011-A001359-32
N° 11P03919 / N°11P03921

First Posted:

Apr 24, 2013

Last Update Posted:

Nov 3, 2015

Last Verified:

Nov 1, 2015

Keywords provided by University Hospital, Caen

Circadian Rhythm

Exercise

Reflex, Vestibular Ocular

Postural Balance

Additional relevant MeSH terms:

Vestibular Diseases

Study Results

No Results Posted as of Nov 3, 2015