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

Primary Purpose

Vestibular Disorder

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Betahistine

Exercise-based vestibular rehabilitation

About this trial

This is an interventional treatment trial for Vestibular Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Group A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks;

Group B will be prescribed with Betahistine 12mg, twice daily for 7 days;

Group C will receive an combination of Exercise-based VR plus Betahistine.

Outcomes

Primary Outcome Measures

Balance function

Balance function, measured by computerized dynamic posturography.

Secondary Outcome Measures

Duration of RD symptoms

Patients self-reported days for RD onset to disappear

Quality of life assessment scale

Measured by Dizziness and Handicap Inventory

Otolith function

Analyzed as vestibular evoked myogenic potenials (VEMPs)

Daily function

Daily function quantified by Vestibular Activities and Participation (VAP) questionnaire.

Full Information

NCT ID

NCT03624283

First Posted

July 31, 2018

Last Updated

August 12, 2018

Sponsor

Eye & ENT Hospital of Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03624283

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eye & ENT Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibular Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Group A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks;

Arm Title

Group B

Arm Type

Experimental

Arm Description

Group B will be prescribed with Betahistine 12mg, twice daily for 7 days;

Arm Title

Group C

Arm Type

Experimental

Arm Description

Group C will receive an combination of Exercise-based VR plus Betahistine.

Intervention Type

Drug

Intervention Name(s)

Betahistine

Intervention Description

Betahistine is used in the treatment of and vertigo.

Intervention Type

Behavioral

Intervention Name(s)

Exercise-based vestibular rehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

Balance function

Description

Balance function, measured by computerized dynamic posturography.

Time Frame

Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation

Secondary Outcome Measure Information:

Title

Duration of RD symptoms

Description

Patients self-reported days for RD onset to disappear

Time Frame

Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.

Title

Quality of life assessment scale

Description

Measured by Dizziness and Handicap Inventory

Time Frame

Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.

Title

Otolith function

Description

Analyzed as vestibular evoked myogenic potenials (VEMPs)

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.

Title

Daily function

Description

Daily function quantified by Vestibular Activities and Participation (VAP) questionnaire.

Time Frame

Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huawei Li

Phone

+86-13524844652

hwli@shmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Peixia Wu

13524844652@163.com

Facility Information:

Facility Name

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

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200031

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huawei Li, Phd &MD

hwli@shmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Peixia Wu, MS &MD

13524844652@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

31217316

Citation

Wu P, Cao W, Hu Y, Li H. Effects of vestibular rehabilitation, with or without betahistine, on managing residual dizziness after successful repositioning manoeuvres in patients with benign paroxysmal positional vertigo: a protocol for a randomised controlled trial. BMJ Open. 2019 Jun 18;9(6):e026711. doi: 10.1136/bmjopen-2018-026711.

Results Reference

derived

Learn more about this trial

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

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