NCT01839409

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

April 22, 2013

Last Update Submit

November 2, 2015

Conditions

Unspecified Disorder of Vestibular Function, Bilateral

Keywords

Circadian RhythmExerciseReflex, Vestibular OcularPostural Balance

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

control

NO INTERVENTION

Control without vestibular stimulation

Bilateral areflexia

NO INTERVENTION

Patient with vestibular bilateral areflexia

Areflexia controls

NO INTERVENTION

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

vestibular stimulation

EXPERIMENTAL

Subjects submitted to vestibular stimulation in order to improve circadian rhythms

Behavioral: vestibular stimulation

Interventions

vestibular stimulationBEHAVIORAL

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

vestibular stimulation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No treatment changing vigilance/wakefulness
  • Moderate caffein uptake (2 to 3 cups a day)
  • Moderate smoker (5 cigarettes a day)
  • Regular sleeping habits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

RECRUITING

MeSH Terms

Conditions

Vestibular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesBehavior

Study Officials

  • Pierre Denise, MD, PhD

    University Hospital of Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Denise, MD PhD

CONTACT

33231068214pierre.denise@unicaen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 24, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2016

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

FR(1)