Dizziness; SyndromeSENSORIEL2NCT05525728
Integrative Study of Vestibular Pathology
A study testing Neurosensory in people with Dizziness; Syndrome, run by University Hospital, Caen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dizziness; Syndrome
- What is being tested?
- Neurosensory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jun 2022to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient (18-80 years old)
- Patient with an acute or chronic vestibular pathology according to ENT diagnostic criteria
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Caen University Hospital
Caen, 14033
Stéphane BESNARD, MD, PhD, +33231065332, stephane.besnard@unicaen.fr
Stéphane BESNARD, MD, PhD
- Recruiting
Frédéric Xavier
Vitrolles, 13127
Frédéric XAVIER, PhD, +33231065332, frederic.xavier@etu.univ-amu.fr
About this study
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
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.
Read the 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.
- Conditions
- Dizziness; Syndrome
- Being tested
- Neurosensory
- Keywords
- posture, vertigo, cognition, emotion, physiotherapist, vestibular system, balance
- Medical subject headings
- Dizziness, Syndrome, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurosensoryOther
Physiological and neurophysiological investigations
| Study group | Role | What they receive |
|---|---|---|
| patient | Other | One cohort of patients Receives: Other: Neurosensory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture
postural measurement
Measured: through follow-up, an average of 6 months
Cognition
Spatial cognitive performance in a calibrated virtual radial maze
Measured: through follow-up, an average of 6 months
Personnality characteristic
Evaluation of the BIg Five inventory test
Measured: through follow-up, an average of 6 months
Sleep
Quantitative sleep recording
Measured: through follow-up, an average of 6 months
Emotion
Anxiety measurement via questionnary
Measured: through follow-up, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start18 Jun 2022
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dizziness; SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphane BESNARD, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525728
- Sponsor's protocol ID
- 2020-A02956-33
- Acronym
- SENSORIEL2
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05525728
- Acronym / sponsor ID
- SENSORIEL2 / 2020-A02956-33
- Conditions
- Dizziness; Syndrome
- Keywords
- posture, vertigo, cognition, emotion, physiotherapist, vestibular system, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a group of patient suffering from vestibular pathology will be investigated regardless the etiology of the vertigo or dizziness
| Arm | Type | Receives |
|---|---|---|
| patient | Other | Other: NeurosensoryOne cohort of patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patient (18-80 years old)
- Patient with an acute or chronic vestibular pathology according to ENT diagnostic criteria
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurosensoryPhysiological and neurophysiological investigations | Other | patient |
Primary outcome
Posture
Time frame: through follow-up, an average of 6 months
postural measurement
Cognition
Time frame: through follow-up, an average of 6 months
Spatial cognitive performance in a calibrated virtual radial maze
Personnality characteristic
Time frame: through follow-up, an average of 6 months
Evaluation of the BIg Five inventory test
Sleep
Time frame: through follow-up, an average of 6 months
Quantitative sleep recording
Emotion
Time frame: through follow-up, an average of 6 months
Anxiety measurement via questionnary
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurosensory in people with Dizziness; Syndrome, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posture (time frame: through follow-up, an average of 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.