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

Vestibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03624283
• Other study ID #: vestibular rehabilitation
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2018
• Source: Eye & ENT Hospital of Fudan University
• Contact: Huawei Li
• Phone: +86-13524844652
• Email: hwli[@]shmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 183
• Est. completion date: July 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

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;

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vestibular Diseases
• Vestibular Disorder

Intervention

Drug:
• Betahistine
Betahistine is used in the treatment of and vertigo.

Behavioral:
• Exercise-based vestibular rehabilitation
Exercise-based vestibular rehabilitation (VR) has proven to be an effective way for managing dizziness by relieving symptoms and improving balance and postural stability.

Locations

Country	Name	City	State
China	Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance function	Balance function, measured by computerized dynamic posturography.	Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Secondary	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.
Secondary	Quality of life assessment scale	Measured by Dizziness and Handicap Inventory	Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
Secondary	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.
Secondary	Daily function	Daily function quantified by Vestibular Activities and Participation (VAP) questionnaire.	Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation