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Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients

NCT04578470 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-09

No results posted yet for this study

Summary

Benign Paroxysmal Positional Vertigo (BPPV) is the most common cause of vertigo in older adults (Parham \& Kuchel, 2016). It is caused by dislodged otoconia, which fall from the utricular macula into the semicircular canals causing them to move through the canals with the effect of gravity (Parnes et al., 2003). Treatment of BPPV is primarily with Canalith Repositioning Procedure (CRP) with more than 80% success rates. However, BPPV can recur in 10-20% of the time and in some long-term follow-up studies reporting up to 50% recurrence rates (Fife et al., 2008). Despite BPPV being considered a benign self-limiting condition, it has far reaching physical and psychosocial consequences for the geriatric population such as injuries from falls precipitated by vertiginous attacks and fear of unexpected vertigo leading to restriction of daily activities and functional decline (Balatsouras et al., 2018; Kao et al., 2009). Studies have shown that the 1-year prevalence of individuals with BPPV attacks rises steeply with age, with the cumulative (lifetime) incidence of BPPV reaching almost 10% by the age of 80 (Parham \& Kuchel, 2016). Aging has also been shown to be a primary risk factor for idiopathic BPPV, with events such as prolonged bed rest postulated for being a trigger for BPPV (Parham \& Kuchel, 2016). BPPV is also noted to be underreported in the elderly mainly due to the different manifestations such as less rotatory vertigo and more nonspecific dizziness and instability, with consecutive examinations in geriatric population revealing that 9% of elderly have unrecognized BPPV (Oghalai et al., 2000). Given the increased prevalence and severe implications of BPPV on there is a strong impetus for this study to lower the recurrence of BPPV in this vulnerable older population.

Conditions

  • Benign Paroxysmal Positional Vertigo

Interventions

DRUG

Vitamin D

Daily 2000 IU cholecalciferol(two tablets) for 13 weeks,and daily 1000 IUcholecalciferol(1 tablet) foranother 13 weeks.

DRUG

Placebo

two tablets daily for 13weeks then 1 tablet daily for13 weeks

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-11-01
Completion
2022-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04578470 on ClinicalTrials.gov