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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930485
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Southend University Hospital Foundation NHS Trust

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors for Persistent Postural-Perceptual Dizziness Development
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : April 9, 2020
Estimated Study Completion Date : April 9, 2020

Resource links provided by the National Library of Medicine





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.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

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


Contacts
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Contact: Craig W Mackerness, PhD 01702 385089 ext 5089 craig.mackerness@southend.nhs.uk
Contact: Bernard Hadebe, MSc 01702 385089 ext 5089 bernard.hadebe@southend.nhs.uk

Locations
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United Kingdom
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
Contact: Aaron Trinidade, MBBS    01702 385089 ext 5089    aaron.trinidade@southend.nhs.uk   
Contact: Paula Harman, PhD    01702 385089 ext 5089    paula.harman@southend.nhs.uk   
Sponsors and Collaborators
Southend University Hospital Foundation NHS Trust
Investigators
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Principal Investigator: Aaron Trinidade, MBBS CI
Study Director: Bhaskar Dasgupta, MD R&D Director
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Responsible Party: Southend University Hospital Foundation NHS Trust
ClinicalTrials.gov Identifier: NCT03930485    
Other Study ID Numbers: 09042019
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vertigo
Dizziness
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases