Vestibular DisorderNCT03624283
Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV
A study testing Betahistine and Exercise-based vestibular rehabilitation in people with Vestibular Disorder, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Betahistine and Exercise-based vestibular rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
Peixia Wu contact
China1 site, 1 recruiting
- Recruiting
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200031
Huawei Li, Phd &MD, hwli@shmu.edu.cn
Peixia Wu, MS &MD, 13524844652@163.com
About this study
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
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.
- Conditions
- Vestibular Disorder
- Being tested
- Betahistine, Exercise-based vestibular rehabilitation
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetahistineDrug
Betahistine is used in the treatment of and vertigo.
Exercise-based vestibular rehabilitationBehavioural
Exercise-based vestibular rehabilitation (VR) has proven to be an effective way for managing dizziness by relieving symptoms and improving balance and postural stability.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks; Receives: Behavioral: Exercise-based vestibular rehabilitation |
| Group B | Experimental | Group B will be prescribed with Betahistine 12mg, twice daily for 7 days; Receives: Drug: Betahistine |
| Group C | Experimental | Group C will receive an combination of Exercise-based VR plus Betahistine. Receives: Drug: Betahistine; Behavioral: Exercise-based vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance function
Balance function, measured by computerized dynamic posturography.
Measured: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Secondary outcomes (4)
Duration of RD symptoms
Patients self-reported days for RD onset to disappear
Measured: Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
Quality of life assessment scale
Measured by Dizziness and Handicap Inventory
Measured: Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
Otolith function
Analyzed as vestibular evoked myogenic potenials (VEMPs)
Measured: 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
Daily function quantified by Vestibular Activities and Participation (VAP) questionnaire.
Measured: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huawei Li, Ph.D, MD, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624283
- Sponsor's protocol ID
- vestibular rehabilitation
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31217316
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03624283
- Acronym / sponsor ID
- vestibular rehabilitation
- Conditions
- Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Exercise-based vestibular rehabilitationGroup A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks; |
| Group B | Experimental | Drug: BetahistineGroup B will be prescribed with Betahistine 12mg, twice daily for 7 days; |
| Group C | Experimental | Drug: Betahistine, Behavioral: Exercise-based vestibular rehabilitationGroup C will receive an combination of Exercise-based VR plus Betahistine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (10 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetahistineBetahistine is used in the treatment of and vertigo. | Drug | Group B, Group C |
| Exercise-based vestibular rehabilitationExercise-based vestibular rehabilitation (VR) has proven to be an effective way for managing dizziness by relieving symptoms and improving balance and postural stability. | Behavioural | Group A, Group C |
Primary outcome
Balance function
Time frame: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Balance function, measured by computerized dynamic posturography.
4 secondary outcomes
Duration of RD symptoms
Time frame: Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
Quality of life assessment scale
Time frame: Change from baseline at 4 weeks, 8 weeks and 12 weeks postrandomisation.
Otolith function
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.
Daily function
Time frame: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 31217316Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peixia Wu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betahistine and Exercise-based vestibular rehabilitation in people with Vestibular Disorder, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huawei Li (+86-13524844652, hwli@shmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance function (time frame: Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.