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

Eye & ENT Hospital of Fudan University

Status: Unknown

Conditions: Vestibular Disorder

Treatments: Behavioral: Exercise-based vestibular rehabilitation; Drug: Betahistine

Study type: Interventional

Funder types: Other

Identifiers

NCT03624283

vestibular rehabilitation

Details and patient eligibility

About

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.

Enrollment: 183 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

Behavioral: Exercise-based vestibular rehabilitation

Group B

Experimental group

Description:

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

Treatment:

Drug: Betahistine

Group C

Experimental group

Description:

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

Treatment:

Behavioral: Exercise-based vestibular rehabilitation

Drug: Betahistine