Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales (PERSOCOR)
Primary Purpose
Patients With Acute or Chronic Otoneurological Disorders, Patients Presenting or Having Experienced Dizziness and / or Balance Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire Measures
Sponsored by
About this trial
This is an interventional other trial for Patients With Acute or Chronic Otoneurological Disorders
Eligibility Criteria
Inclusion Criteria:
For patient:
- Age ≥ 18 years
- Patient with acute or chronic otoneurological disorders
- Patient having or having experienced dizziness and / or balance disorders
- Patient with PPPD
- Fluency in French
- Having given free and informed written consent
- Being affiliated with or benefiting from social security
For control subjects:
- Age ≥ 18 years
- Fluency in French
- Having given free and informed written consent
- Being affiliated with or benefiting from social security.
Exclusion Criteria:
For patient:
-Past or present psychiatric and neurological disease (other than otoneurological or PPPD, as declared by the participant)
For control subjects:
-Past or present psychiatric and neurological disease (as declared by the participant) and vestibular and/or auditory system disorders (as declared by the participant)
For all participants:
- Persons still in a period of exclusion from another study and persons simultaneously participating in another study
- Subject to a measure for the protection of justice
Sites / Locations
- Hôpital Européen MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Patients
Control subjects
Arm Description
Patients with acute or chronic otoneurological disorders, presenting or having experienced dizziness and / or balance disorders
Outcomes
Primary Outcome Measures
Scores from the CDS questionnaire translated according to standardized methods (forward translation, back translation, consensus) in patients with other vestibular disorders and control subjects.
Scores from the Niigata PPPD questionnaire translated according to standardized methods (forward translation, back translation, consensus) in patients with PPPD, patients with other vestibular disorders and control subjects.
Secondary Outcome Measures
Measurement of the HADS score in patients with PPPD, in patients with other vestibular disorders and in control subjects
Measurement of the DHI score in patients with PPPD, patients with other vestibular disorders and control subjects
Full Information
NCT ID
NCT05249283
First Posted
January 18, 2022
Last Updated
April 13, 2022
Sponsor
Hôpital Européen Marseille
1. Study Identification
Unique Protocol Identification Number
NCT05249283
Brief Title
Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales
Acronym
PERSOCOR
Official Title
Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital Européen Marseille
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
Depersonalization-derealization (DD) disorders are a clinical phenomenon characterized by feeling disconnected or detached from one's self. Individuals may report feeling as if they are an outside observer of their own thoughts or body, and often report feeling a loss of control over their thoughts or actions.
Several scales have been developed to measure DD, and the Cambridge Depersonalization Scale (CDS) appears to be the most relevant and consistent to characterize the clinical symptoms of these disorders as well as their duration and frequency. This scale, originally written in English, must be translated and validated according to standardized methods that include testing steps patients with dizziness and in individuals with no vestibular disorder.
Persistent postural-perceptual dizziness (PPPD) is a chronic, persistent vestibular syndrome generally preceded by acute vestibular disorders. The main symptoms are rotational dizziness, unsteadiness and / or non-rotating dizziness that are exacerbated by upright posture, walking, active or passive movement, and exposure to moving visual stimuli or complex visual patterns. To help diagnose this syndrome, a questionnaire was developed in Japan in 2019, the Niigata questionnaire, however no French version has yet been validated. Similarly, this scale needs to be validated in patient with PPPD and in control populations.
The main objective of this study is to validate the French translation of these two scales, the CDS questionnaire and the Niigata PPPD questionnaire, according to standard methods (forward translation, back translation, consensus).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Acute or Chronic Otoneurological Disorders, Patients Presenting or Having Experienced Dizziness and / or Balance Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients with acute or chronic otoneurological disorders, presenting or having experienced dizziness and / or balance disorders
Arm Title
Control subjects
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Questionnaire Measures
Intervention Description
Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)
Primary Outcome Measure Information:
Title
Scores from the CDS questionnaire translated according to standardized methods (forward translation, back translation, consensus) in patients with other vestibular disorders and control subjects.
Time Frame
24 months
Title
Scores from the Niigata PPPD questionnaire translated according to standardized methods (forward translation, back translation, consensus) in patients with PPPD, patients with other vestibular disorders and control subjects.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Measurement of the HADS score in patients with PPPD, in patients with other vestibular disorders and in control subjects
Time Frame
24 months
Title
Measurement of the DHI score in patients with PPPD, patients with other vestibular disorders and control subjects
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For patient:
Age ≥ 18 years
Patient with acute or chronic otoneurological disorders
Patient having or having experienced dizziness and / or balance disorders
Patient with PPPD
Fluency in French
Having given free and informed written consent
Being affiliated with or benefiting from social security
For control subjects:
Age ≥ 18 years
Fluency in French
Having given free and informed written consent
Being affiliated with or benefiting from social security.
Exclusion Criteria:
For patient:
-Past or present psychiatric and neurological disease (other than otoneurological or PPPD, as declared by the participant)
For control subjects:
-Past or present psychiatric and neurological disease (as declared by the participant) and vestibular and/or auditory system disorders (as declared by the participant)
For all participants:
Persons still in a period of exclusion from another study and persons simultaneously participating in another study
Subject to a measure for the protection of justice
Facility Information:
Facility Name
Hôpital Européen Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam BENNANI
Phone
04 13 42 83 51
Email
m.bennani@hopital-europeen.fr
First Name & Middle Initial & Last Name & Degree
Maya ELZIERE, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales
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