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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03624283
Enrollment
183
Registered
2018-08-10
Start date
2018-09-01
Completion date
2020-07-31
Last updated
2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Disorder

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.

Interventions

Betahistine is used in the treatment of and vertigo.

BEHAVIORALExercise-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.

Sponsors

Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Balance functionChange from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisationBalance function, measured by computerized dynamic posturography.

Secondary

MeasureTime frameDescription
Duration of RD symptomsChange from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.Patients self-reported days for RD onset to disappear
Quality of life assessment scaleChange from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.Measured by Dizziness and Handicap Inventory
Otolith functionChange 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 functionChange from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisationDaily function quantified by Vestibular Activities and Participation (VAP) questionnaire.

Countries

China

Contacts

Primary ContactHuawei Li
hwli@shmu.edu.cn+86-13524844652
Backup ContactPeixia Wu
13524844652@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026