To determine the prevalence of BPPV in the elderly patients with an increased risk of fallsSecondary ObjectivesTo compare the outcomes within BPPV patients before and after successful treatment with a canalith repositioning manoeuvre (CRM):* The…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome
The occurrence of definitive or possible BPPV after performing a diagnostic
manoeuvre according to the *Consensus Document of the Committee for the
Classification of Vestibular Disorders of the Bárány Society*.
Definitive BPPV
o Recurrent attacks of positional vertigo or positional dizziness provoked by a
diagnostic manoeuvre.
o Duration of attacks in most cases <1min.
o Positional nystagmus elicited after a latency of one or few seconds by a
diagnostic manoeuvre.
o Not attributable to another disorder.
Possible BPPV
It is reasonable that the amount of otoconia in the semi-circular canal is
sufficient to evoke subjective symptoms but insufficient to stimulate the
vestibulo-ocular reflex.
o Recurrent attack of positional vertigo or positional dizziness provoked by a
diagnostic manoeuvre.
o Duration of attacks in most cases <1min.
o No positional nystagmus objectified by diagnostic manoeuvres.
Secondary outcome
1. Fall incidents
To compare the severity and amount of fall incidents before and after
successful treatment for BPPV and between patient groups, an evaluation of fall
incidents 6 months prior and 6 months after treatment will be performed.
At the time of diagnosis and treatment (visit 0) a self-administered
questionnaire (See Appendix 14.4) will be taken. The vestibular technician who
performs the diagnostic and therapeutic repositioning manoeuvres will answer
questions about presence, type, affected side and canal of BPPV. Subjects will
receive a self-administered diary to record every single fall incident (see
Appendix 14.5).
2. Hospital Anxiety and Depression Scale
To evaluate the effect of anxiety or depression on the recurrence rate and
number of CRM*s needed the HADS will be used (See Appendix 14.3). The HADS was
developed by Zigmond and Snaith in 1983 and is often used to detect states of
depression and/or anxiety in the setting of a hospital medical outpatient
clinic. The HADS was validated in different Dutch subjects by Spinhoven et al.
in 1997.
Points for questions regarding anxiety and depression are separately
calculated. Cut-off values for both anxiety and depression include:
- Score 8-10: mild problems regarding anxiety or depression
- Score 11-14: moderate problems regarding anxiety or depression
- Score 15-21: severe problems regarding anxiety or depression
Recurrence will be defined as the occurrence of definitive or possible BPPV
after successful treatment within one year.
3. Quality of life
To evaluate the quality of life before and after treatment, between patients
with and without BPPV and to evaluate the effect of the quality of life score
on the recurrence rate and number of CRM*s needed the EQ-5D-5L and EQ VAS will
be used
The EQ-5D-5L is a generic instrument, designed for self-completion, to describe
and value health. It is based on a descriptive system that defines health in
terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort
and Anxiety/Depression. Each dimension has 5 response categories corresponding
to no problems, slight problems, moderate problems, severe problems and extreme
problems.
Background summary
According to the World Health Organisation (WHO) every year 28% to 35% of the
elderly population (>65 years) falls and this number increases as age rises.
Fall incidents can lead to injuries, handicaps and in some cases to death. In
40% to 60% fall incidents result in injuries and 5% of the injuries are
fractures. This increase in morbidity leads to more hospital admissions. A
large retrospective study conducted in the Netherlands assessed trends in falls
mortality in Dutch persons 80 years and older from 2000 through 2016. They
discovered a tremendous increase in total number of lethal falls from 391
deaths in 2000 to 2501 deaths in 2016.
The incidence of dizziness in the elderly population varies from 20% to 30%,
and with every five years increase in age there is a 10% higher chance of an
elderly person suffering from dizziness. Recently, Vieira et al. wrote an
article about common risk factors of fall incidents and about possible methods
to prevent old people from falling. One of the discussed risk factors is a
balance disorder. However, vestibular disturbances, such as benign paroxysmal
positional vertigo (BPPV), as potential reasons for fall incidents were not
discussed. This is a limitation because a considerable number of elderly people
suffer from BPPV, and BPPV may cause fall incidents. Furthermore, BPPV is easy
to treat.
Since it has been proven that elderly people with complaints of
dizziness experience a lower quality of life, ideally BPPV should be treated at
all times. Repositioning manoeuvres, like the Epley or Semont manoeuvre in case
of a posterior BPPV or the Lempert manoeuvre in case of a horizontal BPPV, are
effective and safe conservative treatments. People who suffer from posterior
BPPV can be successfully treated with a single manoeuvre in 85% of the cases.
Retrospective studies demonstrated a decrease in the number of fall incidents
in older people after successful treatment of BPPV. However, the risk of
recurrence after successful treatment appears to be higher in older people10
and in patients with anxiety and/or depression symptoms.
Studies conducted so far demonstrate various prevalences of BPPV in the
elderly. Oghalai et al. recorded the presence of dizziness in the elderly
population using a questionnaire. They found a prevalence of unrecognised BPPV
in 9% of the study population, accompanied with a higher occurrence of fall
incidents. Another study showed BPPV in 1.4% of elderly patients with
complaints of dizziness. However, by asking patients whether they suffered from
dizziness typical for BPPV, a selection was made in advance. It is known that
older people can have BPPV without the typical symptoms, making the former
study probably an underrepresentation of the true prevalence of BPPV in the
elderly population.
Abbott et al. studied patients >65 years of age who had been admitted to the
hospital because of a fall incident. Forty-five percent of this study
population was diagnosed with BPPV. Though, the studied group was very small,
only patients who were admitted to the hospital were included in this study
and determination of a *positive Dix-Hallpike manoeuvre* was not described.
Lawson et al. specifically analysed older patients of a specialised fall clinic
and they found BPPV in 13% of the patients. As the amount of research regarding
prevalence of BPPV and possible related fall incidents in older patients in a
falls clinic is scarce, more research is needed to investigate these parameters.
The aim of our study is to determine the prevalence of BPPV in the elderly
population, referred to the geriatric department with an increased risk for
falling. Secondary, we aim to examine whether there is a reduction of the
number of fall incidents and the severity of fall incidents after a successful
repositioning manoeuvre.
Study objective
To determine the prevalence of BPPV in the elderly patients with an increased
risk of falls
Secondary Objectives
To compare the outcomes within BPPV patients before and after successful
treatment with a canalith repositioning manoeuvre (CRM):
* The number of fall incidents
* The severity of fall incidents
* The level of anxiety and/or depression
* The quality of life
To compare the outcomes between patients with BPPV (and subsequent treatment)
and patients without BPPV:
* The number of fall incidents
* The severity of fall incidents
* The level of anxiety and/or depression
* The quality of life
We will evaluate the effect of anxiety and/or depression and quality of life on
the recurrence rate of BPPV and on the number of CRM*s needed in patients
treated for BPPV.
Study design
The BELFIN trial is designed as a single-centre, pre-post screening study. All
eligible subjects will receive questionnaires and will undergo a diagnostic
manoeuvre to determine whether they suffer from BPPV. For a more detailed
explanation, see the flowchart in Chapter 3 of the Protocol.
During a period of 24 months subjects will be observed. The total research
period will be 30 months.
Setting
A collaboration between the tertiary care center for dizziness, the Apeldoorn
Dizziness Center (ADC) and the specialised falls clinic (Centre of Excellence
for Old Age Medicine) (See Appendix 14.1), both located in Gelre Hospital
Apeldoorn.
Intervention
Subjects eligible for the study will undergo a diagnostic manoeuvre
(Dix-Hallpike or Supine Roll manoeuvre) to test for benign paroxysmal
positional vertigo. In case the diagnostic manoeuvre shows BPPV, subjects will
undergo a canalith repositioning manoeuvre (Epley, Semont, Lempert or Gufoni).
Study burden and risks
It is suggested in multiple clinical studies that canalith repositioning
manoeuvres have good outcomes in the treatment of BPPV. Randomised double-blind
studies demonstrated a canalith repositioning manoeuvre to be superior to sham
manoeuvres in the treatment of BPPV. A Cochrane Review conducted by Hilton and
Pinder in 2014 stated that the Epley manoeuvre is an effective and safe remedy
for posterior canal BPPV. This was based on the results of eleven randomised
controlled trials.
Severe complications from canalith repositioning manoeuvres have not been
reported in randomised controlled trials. The guidelines of the Dutch College
of General Practitioners advise to perform an Epley manoeuvre in case of BPPV.
According to the Clinical Practice Guideline of the American Academy of
Otorhinolaryngology * Head and Neck Surgery Foundation CRM*s are associated
with mild and mostly self-limiting adverse effects such as a sensation of
falling, nausea, vomiting, fainting and conversion to lateral canal BPPV.
Conversion from posterior to lateral canal BPPV occurs in approximately 6-7%.
Nausea occurs in 16.7% up to 32% during a repositioning manoeuvre.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Adult patients, understanding of the Dutch language, aged 65 years or older, referred to the geriatrics with an increased risk for falling according to the Fall-Risk Questionnaire (FRQ)
Exclusion criteria
Active additional neuro-otologic disorders that may mimic BPPV (e.g. vestibular migraine, recurrent vestibulopathy, Ménière*s disease, vertebro-basilair TIAs, acoustic neuroma), severe disability (e.g. neurological, orthopedic, cardiovascular) or serious concurrent illness that might interfere with diagnostic or repositioning manoeuvres.
Design
Recruitment
metc-ldd@lumc.nl
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Register | ID |
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CCMO | NL65860.058.18 |