- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06643702
Prevalence av BPPV Among Elderly in Primary Care
Screening for Benign Paroxysmal Positional Vertigo in Primary Care Among Elderly Presenting With Dizziness, Imbalance, and Increased Tendency to Fall
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emilija Rackauskaite
- Phone Number: +46723965492
- Email: emilija.rackauskaite@regionstockholm.se
Study Locations
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Stockholm
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Saltsjö-Boo, Stockholm, Sweden, 13230
- Recruiting
- Boo health center
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Contact:
- Maria Ahlmark, Operations manager
- Phone Number: + 46812338228
- Email: maria.ahlmark@regionstockholm.se
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Principal Investigator:
- Emilija Rackauskaite
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients aged 65 years or older and present to the primary care clinic with one or several of the following:
- Acute, episodic, or chronic sensation of dizziness/vertigo.
- Subjective or objective imbalance during stance or movements.
- Presented with increased tendency of falls by exhibiting unintentional loss of balance resulting in a fall one or more times in the past 12 months.
Exclusion Criteria:
- Patients not meeting the above epidemiological and medical criteria described under "Inclusion Criteria".
- Patients presenting with pathologies in which head and neck movements/manipulations are contraindicated, including (but not limited to): cervical instability, acute head and neck trauma, known cervical disk prolapse, Arnold-Chiari malformation, vascular pathologies such as carotid sinus syncope, vascular dissection and vertebrobasilarinsufficiency, including patients with paralysis as well as those with reduced mobility, in whom diagnostic maneuvers cannot be correctly performed.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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What is the overall prevalence of BPPV among elderly patients (65 years and older) presenting with symptoms of dizziness, vertigo, unsteadiness, imbalance, or an increased tendency to fall in primary care setting?
Time Frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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What is the prevalence of benign paroxysmal positional vertigo among elderly patients seeking primary care for dizziness, unsteadiness, balance problems and/or an increased tendency to fall but not reporting conventional BPPV symptoms?
Time Frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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Outcome aims to identify prevalence of so-called hidden cases of BPPV.
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From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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What is the prevalence of benign paroxysmal positional vertigo among elderly patients seeking primary care for clear and well defined positional vertigo associated with conventional BPPV presentation?
Time Frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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Outcome aims to identify prevalence of so-called classical cases of BPPV.
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From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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What are the differences in demographic, clinical and life-quality results between BPPV-positive and BPPV-negative groups?
Time Frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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This outcome aims to evaluate differences between the two following patient groups: patients who present with symptoms but have no BPPV and patients who test positive for BPPV.
Metrics that are analysed are: demographic information; current and previous diseases; current medications; frailty; Downtown fall risk index; fall risk according to "World guidelines for falls prevention and management for older adults: a global initiative", DHI-scores, TUG-test results, Dix-Hallpike-test result.
Above mentioned metrics are not analysed between each other, instead the analysis is done for each metric between the two patient groups.
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From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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What are the differences in clinical and life-quality outcomes between so-called "classical" BPPV-cases and "hidden" BPPV-cases before and after treatment?
Time Frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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This outcome aims to evaluate differences in following patient groups: patients who present with conventional BPPV-related symptoms and test positive for BPPV and patients who present with more diffuse symptoms and experience imbalance in during stance or movements or have fallen in the past year and do not report the conventional BPPV symptoms but test positive for BPPV. Metrics that are analysed are: demographic information; current and previous diseases; current medications; frailty; Downtown fall risk index; fall risk according to "World guidelines for falls prevention and management for older adults: a global initiative", DHI-scores upon first visit and follow-up visit, TUG-test results, Dix-Hallpike-test result upon upon first visit and follow-up visit; referral status. Above mentioned metrics are not analysed between each other, instead the analysis is done for each metric between the two mentioned patient groups. |
From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Luca Verrecchia, PhD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLSO 2024-2982
- 2024-05079-01 (Other Identifier: Swedish Ethical Review Authority (Etikprövningsmyndigheten))
Drug and device information, study documents
product manufactured in and exported from the U.S.
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