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RecruitingNCT06643702Updated Oct 28, 2024

Prevalence av BPPV Among Elderly in Primary Care

An observational study in Benign Paroxysmal Positional Vertigo (BPPV), sponsored by Region Stockholm. Recruiting at 1 site in Sweden. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Region Stockholm · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Ages
65 Years and older
Sex
All
01

Study summary

This study aims to investigate whether positional tests should be routinely performed on all elderly patients (65 years and older) presenting to primary care with symptoms of acute, episodic, or chronic dizziness or vertigo, unsteadiness, imbalance, and/or an increased tendency to fall in the past 12 months. Study aims to investigate whether diagnostic maneuvers should be performed regardless of the presence of conventional positional vertigo presentation associated with classical cases of benign paroxysmal positional vertigo (BPPV). Specifically, the study aims to identify "hidden" cases of BPPV and assess the potential benefits of clinical screening and initial treatment of BPPV in primary care setting thus improving the BPPV-related quality of life and reducing the risk of falls in the elderly population.

02

Conditions studied

  • Benign Paroxysmal Positional Vertigo (BPPV)
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Eligible participants are elderly patients aged 65 years and older who present to the primary care clinic with acute, episodic, or chronic dizziness or vertigo, unsteadiness, imbalance, and/or an increased tendency to fall by exhibiting unintentional loss of balance resulting in a fall one or more times in the past 12 months.

Inclusion criteria

Patients aged 65 years or older and present to the primary care clinic with one or several of the following:

  1. Acute, episodic, or chronic sensation of dizziness/vertigo.
  2. Subjective or objective imbalance during stance or movements.
  3. 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

Exclusion Criteria:

  1. Patients not meeting the above epidemiological and medical criteria described under "Inclusion Criteria".
  2. 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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?

    Outcome aims to identify prevalence of so-called hidden cases of BPPV.

    Time frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).

  2. 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?

    Outcome aims to identify prevalence of so-called classical cases of BPPV.

    Time frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).

  3. What are the differences in demographic, clinical and life-quality results between BPPV-positive and BPPV-negative groups?

    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.

    Time frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).

  4. What are the differences in clinical and life-quality outcomes between so-called "classical" BPPV-cases and "hidden" BPPV-cases before and after treatment?

    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.

    Time frame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).

06

Study locations

1 of 1 sites recruiting
  • Boo health center
    Saltsjö-Boo, Stockholm 13230, Sweden
    Recruiting
07

Registry details

Key details

Study ID
NCT06643702
Lead sponsor
Region Stockholm
Collaborators
Karolinska Institutet
Responsible party
Emilija Rackauskaite (Resident doctor in General medicine, Region Stockholm) — Principal investigator
First posted
Oct 16, 2024
Start date
Oct 16, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 28, 2024

Study contacts

Emilija Rackauskaite
Contact
emilija.rackauskaite@regionstockholm.se
+46723965492
Luca Verrecchia, PhD
study director · Karolinska Institutet
View the source record on ClinicalTrials.gov ↗

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