Clinical trial NCT03930485: Risk Factors for Persistent Postural-Perceptual Dizziness Development
Official title: Risk Factors for Persistent Postural-Perceptual Dizziness Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dizziness
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have been given a previous diagnosis of PPPD will be considered as potential cases and screened for inclusion/exclusion criteria. PPPD diagnosis must be based on the CCBS criteria (Table 1). Participants will be identified by a member of the current clinical care team either through clinic notes or in the outpatient clinics.

Brief summary: The primary aim of this study is to determine whether the prevalence of neuroticism, anxiety and body vigilance is higher in patients diagnosed with PPPD compared to those who suffered a vestibular insult but did not develop PPPD and healthy controls. An increased prevalence of one or more of these factors may identify them as risk factors in the development of PPPD. The secondary aim is to understand how PPPD affects quality of life.

Detailed description: The diagnosis persistent postural-perceptual dizziness (PPPD) entered the 11th edition of the World Health Organization's International Classification of Diseases (ICD-11 beta draft) in 2015 following a consensus document on its diagnostic criteria created by the Behavioral Subcommittee of the Committee for the Classification of Vestibular Disorders of the Bárány Society (CCBS) between 2010 and 2014. The ICD-11 describes it as follows: "Persistent non-vertiginous dizziness, unsteadiness, or both lasting three months or more. Symptoms are present most days, often increasing throughout the day, but may wax and wane. Momentary flares may occur spontaneously or with sudden movement. Affected individuals feel worst when upright, exposed to moving or complex visual stimuli, and during active or passive head motion. These situations may not be equally provocative. Typically, the disorder follows occurrences of acute or episodic vestibular or balance-related problems, but may follow non-vestibular insults as well. Symptoms may begin intermittently, and then consolidate. Gradual onset is uncommon." In a previous systematic review of the literature, the authors discuss the pathophysiology and management of PPPD, including certain psychological risk factors. Anxiety has been suggested to play a pivotal role in the maladaptation cycle of PPPD in part by increasing body vigilance and both neuroticism and a pre-existing anxiety disorder have been suggested as predisposing factors for the onset of this maladaptation cycle. Such risk factors may allow the prediction of who might be at risk of developing PPPD after an acute vestibular injury and thus benefit from early treatment.

As PPPD is a relatively new diagnosis, to date there is no study that comprehensively confirms the prevalence of anxiety, neuroticism and/or increased body vigilance in sufferers specifically. It is important to determine this in order to guide further research into treating and potentially preventing its onset.

Eligibility criteria: Inclusion Criteria

* Must have diagnosis of PPPD based on the CCBS criteria
* Aged under 18 years old
* Able to provide informed consent Exclusion Criteria
* No confirmed/firm diagnosis of PPPD
* Aged \<18 years old
* Unable to provide informed consent
* Current clinically significant illness that could confound the study results

Primary outcomes:
measure: Scores of the Generalised Anxiety & Depression - 7 (GAD-7) questionnaire
timeFrame: 1 year
measure: Scores of the Big Five Inventory (BFI) questionnaire
timeFrame: 1 year
measure: Scores from the Body Vigilance Scale (BVS) questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Scores from the Dizziness Handicap Inventory (DHI) questionnaire
timeFrame: 1 year
measure: Scores from the Vertigo Symptom Scale (VSS) questionnaire
timeFrame: 1 year
measure: Scores from the Brief Dizziness Perception Questionnaire (DPQ)
timeFrame: 1 year
Other outcomes:
Locations:
city: Westcliff-on-Sea
country: United Kingdom
facility: Southend Hospital
state: Essex
Study officials:
affiliation: CI
name: Aaron Trinidade, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: R&D Director
name: Bhaskar Dasgupta, MD
role: STUDY_DIRECTOR
References: