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

August 12, 2018 updated by: Huawei Li, Ph.D, MD, Eye & ENT Hospital of Fudan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance function
Time Frame: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
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
Time Frame: Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
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
Time Frame: Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
Measured by Dizziness and Handicap Inventory
Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
Otolith function
Time Frame: 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)
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
Time Frame: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Daily function quantified by Vestibular Activities and Participation (VAP) questionnaire.
Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vestibular rehabilitation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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