Benign Paroxysmal Positional Vertigo (BPPV)NCT06643702
Prevalence av BPPV Among Elderly in Primary Care
An observational study of Benign Paroxysmal Positional Vertigo (BPPV), run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo (BPPV)
- How many people
- 115 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Boo health center
Saltsjö-Boo, Stockholm County, 13230
Maria Ahlmark, Operations manager, + 46812338228, maria.ahlmark@regionstockholm.se
Emilija Rackauskaite
About this study
Official title: Screening for Benign Paroxysmal Positional Vertigo in Primary Care Among Elderly Presenting With Dizziness, Imbalance, and Increased Tendency to Fall
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.
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
Secondary outcomes (4)
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.
Measured: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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.
Measured: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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.
Measured: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
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.
Measured: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start16 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional Vertigo (BPPV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Emilija Rackauskaite, Region Stockholm
- Investigators
- Luca Verrecchia, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643702
- Sponsor's protocol ID
- SLSO 2024-2982
- Other IDs
- 2024-05079-01
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Benign Paroxysmal Positional Vertigo in Primary Care Among Elderly Presenting With Dizziness, Imbalance, and Increased Tendency to Fall
- ClinicalTrials.gov ID
- NCT06643702
- Acronym / sponsor ID
- SLSO 2024-2982
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Verrecchia, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Paroxysmal Positional Vertigo (BPPV), run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilija Rackauskaite (+46723965492, emilija.rackauskaite@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.