Biological Rhythms and Vestibular System (REHAB_Rn'V)

Caen University Hospital

Status: Unknown

Conditions: Unspecified Disorder of Vestibular Function, Bilateral

Treatments: Behavioral: vestibular stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01839409

2011-A001359-32

N° 11P03919 / N°11P03921 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 96 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 4 patient groups

control

No Intervention group

Description:

Control without vestibular stimulation

Bilateral areflexia

No Intervention group

Description:

Patient with vestibular bilateral areflexia

Areflexia controls

No Intervention group

Description:

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

vestibular stimulation

Experimental group

Description:

Subjects submitted to vestibular stimulation in order to improve circadian rhythms

Treatment:

Behavioral: vestibular stimulation