Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV

Study Overview
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Brief Summary
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To investigate the effect of vestibular rehabilitation, with or without medication, on resolving residual dizziness after successful repositioning maneuvers in patients with benign paroxysmal positional.

Official Title
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The Effect of Vestibular Exercise, With or Without Medication, in Managing Residual Dizziness After Successful Repositioning Maneuvers in Patients With Benign Paroxysmal Positional Vertigo

Conditions
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Vestibular Disorder

Intervention / Treatment
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* Drug: Betahistine
* Behavioral: Exercise-based vestibular rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as unilateral BPPV (unilateral posterior semicircular canal BPPV or horizontal semicircular canal BPPV) according to the clinical practice guideline issued by American Academy of Otolaryngology and head and neck surgery (AAO-HNSF) in 2017; Aged 18 80 years; Reporting residual symptoms after successful repositioning maneuvers; Exclusion Criteria: Anterior semicircular canal BPPV or multicanal BPPV; Recurrent BPPV; Subjects with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss; Subjects with severe cervical spine disease; Subjects with severe cardiovascular diseases ; Subjects with known cerebral vascular disease like carotid stenosis; Cognitive impairment; Suspect of significant depression or anxiety as defined as a score of ≥ 8 for each respective scale of Hospital anxiety and depression scale; Pregnant/ lactating or planning to become pregnant during the study period; Had taken vestibulosupressant, antihistamines, and/ or ototoxic medications in the past 3 months;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks; | Behavioral: Exercise-based vestibular rehabilitation<br>* Exercise-based vestibular rehabilitation (VR) has proven to be an effective way for managing dizziness by relieving symptoms and improving balance and postural stability.<br>|
| Experimental: Group B<br>Group B will be prescribed with Betahistine 12mg, twice daily for 7 days; | Drug: Betahistine<br>* Betahistine is used in the treatment of and vertigo.<br>|
| Experimental: Group C<br>Group C will receive an combination of Exercise-based VR plus Betahistine. | Drug: Betahistine<br>* Betahistine is used in the treatment of and vertigo.<br>Behavioral: Exercise-based vestibular rehabilitation<br>* Exercise-based vestibular rehabilitation (VR) has proven to be an effective way for managing dizziness by relieving symptoms and improving balance and postural stability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance function | Balance function, measured by computerized dynamic posturography. | Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of RD symptoms | Patients self-reported days for RD onset to disappear | Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation. | 
| Quality of life assessment scale | Measured by Dizziness and Handicap Inventory | Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation. | 
| Otolith function | Analyzed as vestibular evoked myogenic potenials (VEMPs) | Change from baseline at 4 weeks, 8 weeks and 12 weeks follow-up will be necessary only when the previous examine showing abnormal. | 
| Daily function | Daily function quantified by Vestibular Activities and Participation (VAP) questionnaire. | Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation |