Biological Rhythms and Vestibular System (REHAB_Rn'V)

November 2, 2015 updated by: University Hospital, Caen
The purpose of this study is to study the relationship between the vestibular system and chronobiology

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Basse-Normandie
      • Caen CEDEX, Basse-Normandie, France, 14032
        • Recruiting
        • Umr Ucbn/Inserm U1075 Comete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions.
Time Frame: 3 years
Gain of vestibular ocular reflex Amplitude of vestibular spinal reflex Amplitude and phase of temperature circardian rhythms
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A001359-32
  • N° 11P03919 / N°11P03921 (Other Grant/Funding Number: CRBN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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