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CompletedNCT05249283PERSOCORUpdated Sep 25, 2025

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

An interventional study of Questionnaire Measures in Patients With Acute or Chronic Otoneurological Disorders and Patients Presenting or Having Experienced Dizziness and / or Balance Disorders, sponsored by Hôpital Européen Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Hôpital Européen Marseille · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
612
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Patients With Acute or Chronic Otoneurological Disorders
  • Patients Presenting or Having Experienced Dizziness and / or Balance Disorders
03

In context

Lead sponsor

Hôpital Européen Marseille is the lead sponsor of 30 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
612 participants (actual)

Study arms

  • Experimental
    Patients

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

    Other: Questionnaire Measures

  • Other
    Control subjects

    Other: Questionnaire Measures

Interventions

  • OtherQuestionnaire Measures

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

06

What researchers measure

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

07

Study locations

1 site
  • Hôpital Européen Marseille
    Marseille, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05249283
Lead sponsor
Hôpital Européen Marseille
Responsible party
Sponsor
First posted
Feb 21, 2022
Start date
Mar 31, 2022
Primary completion
Oct 3, 2024
Completion
Oct 3, 2024
Last update
Sep 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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