Clinical trial NCT03624283: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Disorder
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Balance function
timeFrame: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Secondary outcomes:
measure: Duration of RD symptoms
timeFrame: Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
measure: Quality of life assessment scale
timeFrame: Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
measure: Otolith function
timeFrame: Change from baseline at 4 weeks, 8 weeks and 12 weeks follow-up will be necessary only when the previous examine showing abnormal.
measure: Daily function
timeFrame: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
References:
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.