NCT03624283

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

July 31, 2018

Last Update Submit

August 12, 2018

Conditions

Vestibular Disorder

Outcome Measures

Primary Outcomes (1)

  • Balance function

    Balance function, measured by computerized dynamic posturography.

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

Secondary Outcomes (4)

  • Duration of RD symptoms

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

  • Quality of life assessment scale

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

  • 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.

  • Daily function

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

Study Arms (3)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Drug: Betahistine

Group C

EXPERIMENTAL

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

Drug: BetahistineBehavioral: Exercise-based vestibular rehabilitation

Interventions

BetahistineDRUG

Betahistine is used in the treatment of and vertigo.

Group BGroup C
Exercise-based vestibular rehabilitationBEHAVIORAL

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

Group AGroup C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31217316DERIVED

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Huawei Li

CONTACT

+86-13524844652hwli@shmu.edu.cn

Peixia Wu

CONTACT

13524844652@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Otorhinolaryngology

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 10, 2018

Study Start

September 1, 2018

Primary Completion

December 31, 2019

Study Completion

July 31, 2020

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

CN(1)