Risk Factors for Persistent Postural-Perceptual Dizziness Development

NCT03930485 | Completed

• 1 other identifier: 09042019
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness

Outcome Measures

Primary Outcomes (3)

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

  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.

  1 year

• Scores of the Big Five Inventory (BFI) questionnaire

  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.

  1 year

• Scores from the Body Vigilance Scale (BVS) questionnaire

  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.

  1 year

Secondary Outcomes (3)

• Scores from the Dizziness Handicap Inventory (DHI) questionnaire

  1 year

• Scores from the Vertigo Symptom Scale (VSS) questionnaire

  1 year

• Scores from the Brief Dizziness Perception Questionnaire (DPQ)

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Must have diagnosis of PPPD based on the CCBS criteria
• Aged under 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead

Study Sites (1)

Southend Hospital

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

Location

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron Trinidade, MBBS

  CI

  PRINCIPAL INVESTIGATOR

• Bhaskar Dasgupta, MD

  R&D Director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 29, 2019
• Study Start: April 9, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)