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Clinical Trials/NCT03930485
NCT03930485
Completed
Not Applicable

Risk Factors for Persistent Postural-Perceptual Dizziness Development

Mid and South Essex NHS Foundation Trust1 site in 1 country39 target enrollmentApril 9, 2019
ConditionsDizziness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dizziness
Sponsor
Mid and South Essex NHS Foundation Trust
Enrollment
39
Locations
1
Primary Endpoint
Scores of the Generalised Anxiety & Depression - 7 (GAD-7) questionnaire
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 9, 2019
End Date
January 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Scores of the Generalised Anxiety & Depression - 7 (GAD-7) questionnaire

Time Frame: 1 year

Average total scores of the GAD-7 will be compared across each study group. Higher scores indicate higher feelings of anxiety and/or depression in that study group. The minimum score is 0 and the maximum is 21.

Scores from the Body Vigilance Scale (BVS) questionnaire

Time Frame: 1 year

Average scores for each question of the BVS will be compared across each study group. Minimum score is 0, maximum score is 10. Higher scores indicate higher body vigilance towards bodily sensations.

Scores of the Big Five Inventory (BFI) questionnaire

Time Frame: 1 year

Average total scores for each category of the BFI will be compared across each study group. The BFI measures five personality areas: Extraversion, Aggreableness, Conscientiousness, Neuroticism, and Openess. Minimum scores for each subcategory is 1 and the maximum is 5. Higher scores indicate a higher propensity for that personality trait.

Secondary Outcomes

  • Scores from the Vertigo Symptom Scale (VSS) questionnaire(1 year)
  • Scores from the Dizziness Handicap Inventory (DHI) questionnaire(1 year)
  • Scores from the Brief Dizziness Perception Questionnaire (DPQ)(1 year)

Study Sites (1)

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