Clinical trial NCT06643702: Prevalence av BPPV Among Elderly in Primary Care
Official title: Screening for Benign Paroxysmal Positional Vertigo in Primary Care Among Elderly Presenting With Dizziness, Imbalance, and Increased Tendency to Fall
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Paroxysmal Positional Vertigo (BPPV)
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2024-10-16
Enrollment: 115
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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:

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.

Primary outcomes:
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?
timeFrame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
Secondary outcomes:
measure: 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?
timeFrame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
measure: 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?
timeFrame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
measure: What are the differences in demographic, clinical and life-quality results between BPPV-positive and BPPV-negative groups?
timeFrame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
measure: What are the differences in clinical and life-quality outcomes between so-called "classical" BPPV-cases and "hidden" BPPV-cases before and after treatment?
timeFrame: From enrollment to the follow-up visit 2 weeks later in BPPV positive cases (only one visit for negative cases).
Other outcomes:
Locations:
city: Saltsjö-Boo
country: Sweden
facility: Boo health center
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Luca Verrecchia, PhD
role: STUDY_DIRECTOR
References: