Patients With Acute or Chronic Otoneurological DisordersPERSOCORNCT05249283
Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales
A study testing Questionnaire Measures in people with Patients With Acute or Chronic Otoneurological Disorders and Patients Presenting or Having Experienced Dizziness and / or Balance Disorders, run by Hôpital Européen Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients With Acute or Chronic Otoneurological Disorders, Patients Presenting or Having Experienced Dizziness and / or Balance Disorders
- What is being tested?
- Questionnaire Measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to 3 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Questionnaire Measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire MeasuresOther
Patients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with acute or chronic otoneurological disorders, presenting or having experienced dizziness and / or balance disorders Receives: Other: Questionnaire Measures |
| Control subjects | Other | Not described Receives: Other: Questionnaire Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores from the CDS questionnaire translated according to standardized methods (forward translation, back translation, consensus) in patients with other vestibular disorders and control subjects.
Measured: 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.
Measured: 24 months
Secondary outcomes (2)
Measurement of the HADS score in patients with PPPD, in patients with other vestibular disorders and in control subjects
Measured: 24 months
Measurement of the DHI score in patients with PPPD, patients with other vestibular disorders and control subjects
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start31 Mar 2022
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Acute or Chronic Otoneurological DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249283
- Sponsor's protocol ID
- 21-44
- Acronym
- PERSOCOR
- Status last verified
- Sep 2025
- First submitted
- 18 Jan 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meletaki V, Gobinet M, Leonard J, Elziere M, Lopez C. French adaptation and validation of the Niigata PPPD Questionnaire: measure of severity of Persistent Postural-Perceptual Dizziness and its association with psychiatric comorbidities and perceived handicap. Front Neurol. 2024 Jul 30;15:1388805. doi: 10.3389/fneur.2024.1388805. eCollection 2024.
PubMed 39139768
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales
- ClinicalTrials.gov ID
- NCT05249283
- Acronym / sponsor ID
- PERSOCOR / 21-44
- Conditions
- Patients With Acute or Chronic Otoneurological Disorders, Patients Presenting or Having Experienced Dizziness and / or Balance Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Questionnaire MeasuresPatients with acute or chronic otoneurological disorders, presenting or having experienced dizziness and / or balance disorders |
| Control subjects | Other | Other: Questionnaire Measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (7 listed)
- -Past or present psychiatric and neurological disease (other than otoneurological or PPPD, as declared by the participant)
- -Past or present psychiatric and neurological disease (as declared by the participant) and vestibular and/or auditory system disorders (as declared by the participant)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire MeasuresPatients will complete the following questionnaires: CDS questionnaire, Niigata PPPD questionnaire, HAD (Hospital Anxiety and Depression) scale and DHI (Dizziness Handicap Inventory) | Other | Control subjects, Patients |
Primary outcome
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
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
2 secondary outcomes
Measurement of the HADS score in patients with PPPD, in patients with other vestibular disorders and in control subjects
Time frame: 24 months
Measurement of the DHI score in patients with PPPD, patients with other vestibular disorders and control subjects
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Results publication: PubMed 39139768Meletaki V, Gobinet M, Leonard J, Elziere M, Lopez C. French adaptation and validation of the Niigata PPPD Questionnaire: measure of severity of Persistent Postural-Perceptual Dizziness and its association with psychiatric comorbidities and perceived handicap. Front Neurol. 2024 Jul 30;15:1388805. doi: 10.3389/fneur.2024.1388805. eCollection 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Measures in people with Patients With Acute or Chronic Otoneurological Disorders and Patients Presenting or Having Experienced Dizziness and / or Balance Disorders, run by Hôpital Européen Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05249283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.