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

NCT05249283 | Completed

• 1 other identifier: 21-44
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Scores from the CDS questionnaire translated according to standardized methods (forward translation, back translation, consensus) in patients with other vestibular disorders and control subjects.

  24 months

• 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.

  24 months

Secondary Outcomes (2)

• Measurement of the HADS score in patients with PPPD, in patients with other vestibular disorders and in control subjects

  24 months

• Measurement of the DHI score in patients with PPPD, patients with other vestibular disorders and control subjects

  24 months

Study Arms (2)

Patients

EXPERIMENTAL

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

Other: Questionnaire Measures

Control subjects

OTHER

Other: Questionnaire Measures

Interventions

Questionnaire Measures 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; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Subject to a measure for the protection of justice

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Hôpital Européen Marseille

Marseille, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 21, 2022
• Study Start: March 31, 2022
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)