Risk Factors for Persistent Postural-Perceptual Dizziness Development (RIPPPDD)
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|ClinicalTrials.gov Identifier: NCT03930485|
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : December 22, 2020
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Risk Factors for Persistent Postural-Perceptual Dizziness Development|
|Actual Study Start Date :||April 9, 2019|
|Actual Primary Completion Date :||January 31, 2020|
|Actual Study Completion Date :||January 31, 2020|
- 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 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.
- 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 from the Dizziness Handicap Inventory (DHI) questionnaire [ Time Frame: 1 year ]Average total scores for the DHI will be compared across each study group. Minimum score is 0, maximum is 50, higher scores indicate more symptoms of dizziness in day to day life.
- Scores from the Vertigo Symptom Scale (VSS) questionnaire [ Time Frame: 1 year ]Average total scores for the VSS will be compared across each study group. Minimum score is 0, maximum is 60. Higher scores indicate a higher severity of symptoms caused by vertigo.
- Scores from the Brief Dizziness Perception Questionnaire (DPQ) [ Time Frame: 1 year ]Average scores from each question of the DPQ will be measure across each study group. Minimum score is 0, maximum is 10. Higher scores indicate an individual is more affected/more concerned etc regarding their dizziness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930485
|Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY|
|Principal Investigator:||Aaron Trinidade, MBBS||CI|
|Study Director:||Bhaskar Dasgupta, MD||R&D Director|