Benign Paroxysmal Positional Vertigo in the Elderly with an Increased Risk of Fall Incidents

Benign Paroxysmal Positional Vertigo in the Elderly with an Increased Risk of Fall Incidents - BELFIN

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46283

Enrollment

288

Registered

2018-09-28

Start date

2018-11-12

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Paroxysmal Positional Vertigo/Positional Dizziness

Interventions

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 B

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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 CRMs 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 CRMs 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, S	—

Measure

Time frame

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, S

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)