Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales

NCT ID: NCT05249283

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2024-10-03

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).

Conditions

Patients With Acute or Chronic Otoneurological Disorders; Patients Presenting or Having Experienced Dizziness and / or Balance Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Patients

Patients with acute or chronic otoneurological disorders, presenting or having experienced dizziness and / or balance disorders

Group Type: EXPERIMENTAL

Questionnaire Measures

Intervention Type: OTHER

Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)

Control subjects

Group Type: OTHER

Questionnaire Measures

Intervention Type: OTHER

Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)

Interventions

Questionnaire Measures

Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Européen Marseille

Marseille, , France

Countries

France

Other Identifiers

21-44

Identifier Type: -

Identifier Source: org_study_id