Benign Paroxysmal Positional Vertigo Clinical Trial
Official title:
A Double Blinded Randomized Control Trial (RCT) to Evaluate the Effectiveness of Vitamin D Treatment in Lowering the Recurrence Rate of Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients
Verified date | October 2020 |
Source | Changi General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | November 1, 2022 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged >/=50 with a history suggestive of idiopathic BPPV, supported by a positive Dix Hallpike test. The study is to be undertaken in older patients hence the age criteria. - Cognisant or mild neurocognitive impairment (AMT =7) to ensure the patient can provide informed consent. - Both male and female participants will be recruited. Exclusion Criteria: - Patients with identified neurological causes of giddiness - Patients with major neurocognitive impairment (severe dementia) - Patients with sarcoidosis, metastatic disease (lymphoma, multiple myeloma), parathyroid disorders. - Patients with diagnosed osteoporosis or osteopenia who are currently on high dose treatment (50,000 IU/week) - Patients with significant cervical-spinal radiculopathy, spondylolisthesis, lordosis or kyphosis that will affect ability to carry out CRP - Patients with disorders causing fat malabsorption (Short gut syndrome, Celiac disease) that will affect dietary absorption of Vitamin D - Patients with Myasthenia Gravis - Patients with unexplained hypercalcaemia - Pregnant women (although this is extremely unlikely in age >/=50) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Changi General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduce the recurrence rate of BPPV | To determine if Vitamin D replacement in those deplete with Vitamin D, combined with dietary interventions, will reduce exacerbations of BPPV and thereby result in functional improvement. | 2 Years | |
Primary | Delay time to onset of recurrent episodes of BPPV | To determine if Vitamin D replacement in those deplete with Vitamin D, combined with dietary interventions, will reduce exacerbations of BPPV and thereby result in functional improvement. | 2 Years |
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