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出境医 / 临床实验 / Risk Factors for Persistent Postural-Perceptual Dizziness Development (RIPPPDD)

Risk Factors for Persistent Postural-Perceptual Dizziness Development (RIPPPDD)

Study Description
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.

Condition or disease
Dizziness

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.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations

Locations
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United Kingdom
Southend Hospital
Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
Sponsors and Collaborators
Mid and South Essex NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Aaron Trinidade, MBBS CI
Study Director: Bhaskar Dasgupta, MD R&D Director
Tracking Information
First Submitted Date April 9, 2019
First Posted Date April 29, 2019
Last Update Posted Date December 22, 2020
Actual Study Start Date April 9, 2019
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 26, 2019)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors for Persistent Postural-Perceptual Dizziness Development
Official Title Risk Factors for Persistent Postural-Perceptual Dizziness Development
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Dizziness
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 24, 2020) 		39
Original Estimated Enrollment
 (submitted: April 26, 2019) 		25
Actual Study Completion Date January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03930485
Other Study ID Numbers 09042019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mid and South Essex NHS Foundation Trust
Study Sponsor Mid and South Essex NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Aaron Trinidade, MBBS CI
Study Director: Bhaskar Dasgupta, MD R&D Director
PRS Account Mid and South Essex NHS Foundation Trust
Verification Date December 2020

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