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

Not Applicable

• Conditions: Vestibular Disorder
• Interventions: Drug: Betahistine; Behavioral: Exercise-based vestibular rehabilitation

• Registration Number: NCT03624283
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-31
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-10
• Last Update Submitted: 2018-08-12
• Last Update Posted: 2018-08-14
• Study Start: 2018-09-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

1. 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;
2. Aged 18~80 years;
3. Reporting residual symptoms after successful repositioning maneuvers;

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Exclusion Criteria

1. Anterior semicircular canal BPPV or multicanal BPPV;
2. Recurrent BPPV;
3. Subjects with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss;
4. Subjects with severe cervical spine disease;
5. Subjects with severe cardiovascular diseases ;
6. Subjects with known cerebral vascular disease like carotid stenosis;
7. Cognitive impairment;
8. Suspect of significant depression or anxiety as defined as a score of ≥ 8 for each respective scale of Hospital anxiety and depression scale;
9. Pregnant/ lactating or planning to become pregnant during the study period;
10. Had taken vestibulosupressant, antihistamines, and/ or ototoxic medications in the past 3 months;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Exercise-based vestibular rehabilitation	Group C will receive an combination of Exercise-based VR plus Betahistine.
Group A	Exercise-based vestibular rehabilitation	Group A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks;
Group B	Betahistine	Group B will be prescribed with Betahistine 12mg, twice daily for 7 days;
Group C	Betahistine	Group C will receive an combination of Exercise-based VR plus Betahistine.

Primary Outcome Measures

Name	Time	Method
Balance function	Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation	Balance function, measured by computerized dynamic posturography.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China; 🇨🇳 Shanghai, Shanghai, China