Vestibular DisorderNCT06143462
Vestibular Rehabilitation for Unsteadiness After Intratympanic Gentamicin in Patients With Meniere's Disease
A study testing Health Education and 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 efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Health Education and vestibular rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 75 years old;
- Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment;
- Be willing to sign the informed consent of the study.
Who cannot join
- Conformed to neuromuscular disease;
- Conformed to severe cervical spine disease;
- Conformed to congenital inner ear disease (except vestibular migraine(VM))
- Concurrent manifestation of psychiatric or psychological disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial
To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.
Read the detailed description
Previous studies have generally focused on the efficacy of VRT for Meniere's disease, with little attention paid to the effect of VRT on MD patients who still have vestibular dysfunction even after intratympanic gentamicin treatment.
The aim of this study is to compare the efficacy of VRT with usual care in MD patients who experience persistence of unsteadiness 1 month after intratympanic gentamicin treatment, in order to understand whether VR has a positive impact on balance maintenance and vertigo control in MD patients.
- Conditions
- Vestibular Disorder
- Being tested
- Usual care, Health Education, 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.
Usual careDrug
Include anti-dizziness medications, diuretics, or hormone therapy.
Health EducationOther
Include comprehensive health education, fall prevention and lifestyle adjustments.
vestibular rehabilitationBehavioural
Encompass office-based sessions of vestibular rehabilitation treatment once weekly, supplemented by home-based exercises conducted two or three times daily for the remaining duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Group A: usual care (UC) | Active comparator | Group A (UC) will receive conventional medications. Receives: Drug: Usual care; Other: Health Education |
| Group B: vestibular rehabilitation treatment (VRT) | Experimental | Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment. Receives: Behavioral: vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Gait Assessment (FGA)
FGA is a semi-quantitative measure of walking balance ability.
Measured: Change from baseline, at 8 weeks and 6 months post-randomization
Secondary outcomes (4)
Sensory Organization Test (SOT)
SOT is a form of posturography, aiming to distinguish and assess the weight of vestibular, visual, and proprioceptive sensations in maintaining balance.
Measured: Change from baseline, at 8 weeks and 6 months post-randomization
Meniere's Disease Outcomes Questionnaire (MDOQ)
MDOQ is a comprehensive assessment of MD patients' quality of life (QOL) in three dimensions: physical, emotional, and social.
Measured: Change from baseline, at 8 weeks and 6 months post-randomization
Visual Vertigo Analogue Scale (VVAS)
In VVAS, patients estimate the intensity of their symptoms related to dizziness, vertigo, and imbalance.
Measured: Change from baseline, at 8 weeks and 6 months post-randomization
Vestibular Activities and Participation Measure (VAP)
VAP is a 34-item self-report questionnaire, aiming to evaluate the extent of activity limitations and participation restrictions created by vestibular disorders.
Measured: Change from baseline, at 8 weeks and 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huiqian Yu, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143462
- Sponsor's protocol ID
- 202311-MD-ITG-VRT
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tong Q, Zhou Y, Wu P, Yu H. Effect of vestibular rehabilitation treatment (VRT) on patients with unsteadiness after intratympanic gentamicin in Meniere's disease: protocol for a randomised controlled trial. BMJ Open. 2025 Feb 22;15(2):e088722. doi: 10.1136/bmjopen-2024-088722.
PubMed 39987011
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06143462
- Acronym / sponsor ID
- 202311-MD-ITG-VRT
- Conditions
- Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Nov 2023 (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 efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.
Detailed description
Previous studies have generally focused on the efficacy of VRT for Meniere's disease, with little attention paid to the effect of VRT on MD patients who still have vestibular dysfunction even after intratympanic gentamicin treatment.
The aim of this study is to compare the efficacy of VRT with usual care in MD patients who experience persistence of unsteadiness 1 month after intratympanic gentamicin treatment, in order to understand whether VR has a positive impact on balance maintenance and vertigo control in MD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: usual care (UC) | Active comparator | Drug: Usual care, Other: Health EducationGroup A (UC) will receive conventional medications. |
| Group B: vestibular rehabilitation treatment (VRT) | Experimental | Behavioral: vestibular rehabilitationGroup B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged between 18 and 75 years old;
- Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment;
- Be willing to sign the informed consent of the study.
Key exclusion criteria (4 listed)
- Conformed to neuromuscular disease;
- Conformed to severe cervical spine disease;
- Conformed to congenital inner ear disease (except vestibular migraine(VM))
- Concurrent manifestation of psychiatric or psychological disorders.
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 |
|---|---|---|
| Usual careInclude anti-dizziness medications, diuretics, or hormone therapy. | Drug | Group A: usual care (UC) |
| Health EducationInclude comprehensive health education, fall prevention and lifestyle adjustments. | Other | Group A: usual care (UC) |
| vestibular rehabilitationEncompass office-based sessions of vestibular rehabilitation treatment once weekly, supplemented by home-based exercises conducted two or three times daily for the remaining duration of the study. | Behavioural | Group B: vestibular rehabilitation treatment (VRT) |
Primary outcome
Functional Gait Assessment (FGA)
Time frame: Change from baseline, at 8 weeks and 6 months post-randomization
FGA is a semi-quantitative measure of walking balance ability.
4 secondary outcomes
Sensory Organization Test (SOT)
Time frame: Change from baseline, at 8 weeks and 6 months post-randomization
Meniere's Disease Outcomes Questionnaire (MDOQ)
Time frame: Change from baseline, at 8 weeks and 6 months post-randomization
Visual Vertigo Analogue Scale (VVAS)
Time frame: Change from baseline, at 8 weeks and 6 months post-randomization
Vestibular Activities and Participation Measure (VAP)
Time frame: Change from baseline, at 8 weeks and 6 months post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 39987011Tong Q, Zhou Y, Wu P, Yu H. Effect of vestibular rehabilitation treatment (VRT) on patients with unsteadiness after intratympanic gentamicin in Meniere's disease: protocol for a randomised controlled trial. BMJ Open. 2025 Feb 22;15(2):e088722. doi: 10.1136/bmjopen-2024-088722.
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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.
Huiqian Yu principal investigator
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education and 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 4 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 22 Nov 2023. 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 Huiqian Yu (13636423139, yhq925@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Gait Assessment (FGA) (time frame: Change from baseline, at 8 weeks and 6 months post-randomization). 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 NCT06143462, 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 22 Nov 2023.