NCT06643702

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

October 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 16, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

October 13, 2024

Last Update Submit

October 24, 2024

Conditions

Outcome Measures

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?

    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?

    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?

    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?

    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?

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

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boo health center

Saltsjö-Boo, Stockholm County, 13230, Sweden

RECRUITING

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luca Verrecchia, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor in General medicine

Study Record Dates

First Submitted

October 13, 2024

First Posted

October 16, 2024

Study Start

October 16, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations