About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Risk Factors for Persistent Postural-Perceptual Dizziness Development

Clinicaltrials.gov identifier NCT03930485

Recruitment Status Completed

First Posted April 29, 2019

Last update posted September 25, 2020

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
  • Intervention/Treatment:
  • Phase: N/A
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
  • 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 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: January 2020
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
  • 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
Contacts
Locations

United Kingdom, Essex
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea

Sponsors and Collaborators

Southend University Hospital Foundation NHS Trust

Investigators

Principal Investigator: Aaron Trinidade, MBBS CI

Study Director: Bhaskar Dasgupta, MD R&D Director

More Information
  • Responsible Party: Southend University Hospital Foundation NHS Trust
  • ClinicalTrials.gov Identifier: NCT03930485 History of Changes
  • Other Study ID Numbers: 09042019
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: September 25, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Vertigo Dizziness