NCT02851524

Brief Summary

Falls in the elderly population are a major public health problem because of their frequency and their consequences, notably in terms of dependence their cost to society. In most cases, balance disorders related to an impaired vestibular system are blamed, even though there is no formal evidence that this is the case. Vestibular tests in routine otoneurological practice are based on the exploration of vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to screen for vestibular disorders in falls. A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as the pathways via which vestibular afferents are transported to the subject's conscience. Thanks to this apparatus, a stimulus of body movement will be generated, but with limited tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone is able to indicate to subjects their position in space. The subject will be required to detect oscillatory movement, and then to distinguish between a vestibular stimulus and a pulsed auditory stimulus. The study hypothesis is that the movement stimulation generated by our prototype will be sufficient to stimulate the vestibular system, which will manifest itself as a conscious sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2017

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

July 28, 2016

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cinematics of eye movements (amplitude and direction) evaluated by videonystagmography (VNG).

    At Day 0

Study Arms (1)

posturography

EXPERIMENTAL
Other: posturography

Interventions

posturography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years
  • National health insurance cover
  • Written consent
  • Subjects able to understand simple instructions and packaging information and to provide informed consent

You may not qualify if:

  • Vertigo, consciousness disorders, nausea or pain before the tests
  • Bilateral deafness
  • History of neurological, rheumatic or orthopaedic disease likely by itself to trigger a fall
  • Psychiatric disorder likely to compromise participation.
  • Personal history of falls of undetermined cause.
  • Présence de saccades et/ou nystagmus en position statique
  • Femme enceinte

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (1)

  • Guyon M, Chea C, Laroche D, Fournel I, Baudet A, Toupet M, Bozorg Grayeli A. Measuring threshold and latency of motion perception on a swinging bed. PLoS One. 2021 Jul 9;16(7):e0252914. doi: 10.1371/journal.pone.0252914. eCollection 2021.

MeSH Terms

Interventions

Cytidine Diphosphate

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

June 23, 2016

Primary Completion

April 21, 2017

Study Completion

April 21, 2017

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations