Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales (PERSOCOR)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Marseille, France
- Hôpital Européen Marseille
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Control subjects
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Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)
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Experimental: Patients
Patients with acute or chronic otoneurological disorders, presenting or having experienced dizziness and / or balance disorders
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Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
24 months
|
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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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of the HADS score in patients with PPPD, in patients with other vestibular disorders and in control subjects
Time Frame: 24 months
|
24 months
|
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Measurement of the DHI score in patients with PPPD, patients with other vestibular disorders and control subjects
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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