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Completed

NCT Number: NCT05249283

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Européen Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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

  2. 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 outcomes

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

    Time frame: 24 months

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

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Acronym: PERSOCOR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2022
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.