Biological Rhythms and Vestibular System

NCT ID: NCT01839409

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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

Detailed Description

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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

Conditions

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Unspecified Disorder of Vestibular Function, Bilateral

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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control

Control without vestibular stimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Bilateral areflexia

Patient with vestibular bilateral areflexia

Group Type NO_INTERVENTION

No interventions assigned to this group

Areflexia controls

Controls for patients with vestibular bilateral areflexia, matched in sex and age

Group Type NO_INTERVENTION

No interventions assigned to this group

vestibular stimulation

Subjects submitted to vestibular stimulation in order to improve circadian rhythms

Group Type EXPERIMENTAL

vestibular stimulation

Intervention Type BEHAVIORAL

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

Interventions

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vestibular stimulation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Denise, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Caen

Locations

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Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Denise, MD PhD

Role: CONTACT

33231068214

Facility Contacts

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Pierre Denise, MD PhD

Role: primary

332068214

Other Identifiers

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N° 11P03919 / N°11P03921

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-A001359-32

Identifier Type: -

Identifier Source: org_study_id

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