Integrative Study of Vestibular Pathology (SENSORIEL2)
Primary Purpose
Dizziness; Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurosensory
Sponsored by
About this trial
This is an interventional diagnostic trial for Dizziness; Syndrome focused on measuring posture, vertigo, cognition, emotion, physiotherapist, vestibular system, balance
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
Sites / Locations
- Caen University HospitalRecruiting
- Frédéric XavierRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient
Arm Description
One cohort of patients
Outcomes
Primary Outcome Measures
Posture
postural measurement
Cognition
Spatial cognitive performance in a calibrated virtual radial maze
Personnality characteristic
Evaluation of the BIg Five inventory test
Sleep
Quantitative sleep recording
Emotion
Anxiety measurement via questionnary
Secondary Outcome Measures
Full Information
NCT ID
NCT05525728
First Posted
August 23, 2022
Last Updated
August 30, 2022
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT05525728
Brief Title
Integrative Study of Vestibular Pathology
Acronym
SENSORIEL2
Official Title
Integrative Study of Vestibular Pathology With Analysis of Postural, Neurosensory, and Cognitive Disorders: Search for New Markers on the Causes and Consequences of Vertigo
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2022 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness; Syndrome
Keywords
posture, vertigo, cognition, emotion, physiotherapist, vestibular system, balance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a group of patient suffering from vestibular pathology will be investigated regardless the etiology of the vertigo or dizziness
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Other
Arm Description
One cohort of patients
Intervention Type
Other
Intervention Name(s)
Neurosensory
Intervention Description
Physiological and neurophysiological investigations
Primary Outcome Measure Information:
Title
Posture
Description
postural measurement
Time Frame
through follow-up, an average of 6 months
Title
Cognition
Description
Spatial cognitive performance in a calibrated virtual radial maze
Time Frame
through follow-up, an average of 6 months
Title
Personnality characteristic
Description
Evaluation of the BIg Five inventory test
Time Frame
through follow-up, an average of 6 months
Title
Sleep
Description
Quantitative sleep recording
Time Frame
through follow-up, an average of 6 months
Title
Emotion
Description
Anxiety measurement via questionnary
Time Frame
through follow-up, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane BESNARD, MD, PhD
Phone
+33231065332
Email
stephane.besnard@unicaen.fr
First Name & Middle Initial & Last Name & Degree
Stéphane BESNARD, MD, PhD
First Name & Middle Initial & Last Name & Degree
Martin HITIER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sylvain MOREAU, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laetitia PLISSON, MD
Facility Name
Frédéric Xavier
City
Vitrolles
ZIP/Postal Code
13127
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric XAVIER, PhD
Phone
+33231065332
Email
frederic.xavier@etu.univ-amu.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Integrative Study of Vestibular Pathology
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