Integrative Study of Vestibular Pathology | NCT05525728

Studies
Integrative Study of Vestibular Pathology

NCT05525728

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

Sep 2, 2022Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Dizziness; Syndrome

Interventions

Neurosensory

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2022Actual

Primary Completion Date

Jan 31, 2026Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Aug 23, 2022

First Submission Date that Met QC Criteria

Aug 30, 2022

First Posted Date

Sep 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2022

Last Update Posted Date

Sep 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stéphane BESNARD, Associate professor, University Hospital, CaenPrincipal Investigator

Lead Sponsor

University Hospital, CaenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Exploratory posturological, neurosensory, cognitive, emotional, personality and general evaluations (quality of life).

The investigators will characterize a sensory profile quantified by one or more scores from a multi-parameter baysian approach. Each parameter and these scores will be correlated to the type of vestibular damage and its recovery in order to establish diagnostic, prognostic and therapeutic follow-up markers.

Detailed Description

This is an exploratory neurophysiological work that aims to identify diagnostic, prognostic and therapeutic markers in vestibular pathology.

Theinvestigators wish to characterize the neurosensory profile of individuals using new exploration paradigms provided by a new posturology platform coupled with virtual reality scenarios and by proposing a complete transversal approach in terms of evaluation of the subjects: personality, cognition, emotion including the depressive state, sensory strategy, general data.

Baysian statistical approaches and linear mixed model will be used to determine markers of sensory profile correlated to the vestibular damage for diagnostic, prognostic and therapeutic follow-up.

The investigators aim to be able to better characterize the cognitive-emotional and sensory deficits expressed by the vertiginous and unstable patients, to integrate it into the evaluation of the vestibular pathology, to use these markers to better discriminate the underlying physiopathological mechanisms, and to improve at the same time the diagnosis of the functional attack and the rehabilitation follow-up of the patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient	Other	One cohort of patients	Other: Neurosensory

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurosensory	Other	Physiological and neurophysiological investigations	patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Posture	postural measurement	through follow-up, an average of 6 months
Cognition	Spatial cognitive performance in a calibrated virtual radial maze	through follow-up, an average of 6 months
Personnality characteristic	Evaluation of the BIg Five inventory test	through follow-up, an average of 6 months
Sleep	Quantitative sleep recording	through follow-up, an average of 6 months
Emotion	Anxiety measurement via questionnary	through follow-up, an average of 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patient (18-80 years old)
Patient with an acute or chronic vestibular pathology according to ENT diagnostic criteria

Exclusion Criteria:

Subjects under 18 years of age
Pregnant or breastfeeding women,
Persons in an emergency situation or unable to give their consent, including adults under guardianship
Person under legal protection
Patient presenting a vertigo or postural disorders of non vestibular etiology
Persons deprived of liberty, minors, protected adults,
Patients with an intercurrent neurological pathology including cerebellar pathology
Inclusion of the subject in another interventional research protocol with pharmacological aim during the present study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caen University Hospital	Recruiting	Caen		14033	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004244	Dizziness
D013577	Syndrome
D014717	Vertigo

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided