Vestibular NeuritisNCT03821155
Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?
A study testing Vestibular rehabilitation and Corticosteroid in people with Vestibular Neuritis, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
To investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Neuritis
- What is being tested?
- Vestibular rehabilitation and Corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2019to 1 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years of age
- Medical history compatible with vestibular neuritis
- Verification of vestibular neuritis with positive romberg test, pathological v-HIT and horizontal nystagmus with a rotatory component.
Who cannot join
- Former medical history with vestibular dysfunction
- Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
- Onset of symptoms 14 days before recruitment to the study
- Focal neurological symptoms/signs
- Contraindication to prednisolone treatment
- Problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otolaryngology, Head & Neck Surgery and Audiology
Aalborg, North Denmark, 9000
About this study
Official title: Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?
To investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.
Read the detailed description
Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient will undergo randomization for a specific treatment.
- Conditions
- Vestibular Neuritis
- Being tested
- Vestibular rehabilitation, Corticosteroid
- Keywords
- Vestibular Neuritis, SHIMP (suppressing head impulse paradigm), SVV (subjective visual vertical), Vestibular rehabilitation, Prednisolone, v-HIT (video head impulse test), Vestibular Neuronitis
- Medical subject headings
- Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitationOther
Specialized physical therapy aimed at restoring balance
CorticosteroidDrug
Prednisolone
| Study group | Role | What they receive |
|---|---|---|
| Neuritis vestibularis (group 1) | Active comparator | Corticosteroid ("prednisolone") Receives: Drug: Corticosteroid |
| Neuritis vestibularis (group 2) | Experimental | Corticosteroid ("prednisolone") + vestibular rehabilitation Receives: Other: Vestibular rehabilitation; Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppressing head impulse paradigm (SHIMP)
SHIMP equipment will objectively quantify change of vestibular function.
Measured: 6 month
Subjective visual vertical (SVV)
SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function
Measured: 6 month
Video head impulse test (v-HIT)
v-HIT equipment will objectively quantify change of vestibular function.
Measured: 6 month
Dizziness handicap inventory (DHI) questionnaire
Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Feb 2019
- Primary completion1 Jul 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular NeuritisStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Model description
- Patients randomized to two different treatments: 1. corticosteroid treatment ("prednisolone") 2. combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Dupont Hougaard, Aalborg University Hospital
- Investigators
- Dan D Hougaard, MD, Principal investigator, Aalborg University HospitalMartin H Wolder, MS, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821155
- Sponsor's protocol ID
- 2018-166
- Status last verified
- Jul 2022
- First submitted
- 21 Jan 2019
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?
- ClinicalTrials.gov ID
- NCT03821155
- Acronym / sponsor ID
- 2018-166
- Conditions
- Vestibular Neuritis
- Keywords
- Vestibular Neuritis, SHIMP (suppressing head impulse paradigm), SVV (subjective visual vertical), Vestibular rehabilitation, Prednisolone, v-HIT (video head impulse test), Vestibular Neuronitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 29 Jan 2019 (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 which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.
Detailed description
Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient will undergo randomization for a specific treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients randomized to two different treatments: 1. corticosteroid treatment ("prednisolone") 2. combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation
| Arm | Type | Receives |
|---|---|---|
| Neuritis vestibularis (group 1) | Active comparator | Drug: CorticosteroidCorticosteroid ("prednisolone") |
| Neuritis vestibularis (group 2) | Experimental | Other: Vestibular rehabilitation, Drug: CorticosteroidCorticosteroid ("prednisolone") + vestibular rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years of age
- Medical history compatible with vestibular neuritis
- Verification of vestibular neuritis with positive romberg test, pathological v-HIT and horizontal nystagmus with a rotatory component.
Key exclusion criteria (6 listed)
- Former medical history with vestibular dysfunction
- Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
- Onset of symptoms 14 days before recruitment to the study
- Focal neurological symptoms/signs
- Contraindication to prednisolone treatment
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 |
|---|---|---|
| Vestibular rehabilitationSpecialized physical therapy aimed at restoring balance | Other | Neuritis vestibularis (group 2) |
| CorticosteroidPrednisolone | Drug | Neuritis vestibularis (group 1), Neuritis vestibularis (group 2) |
Primary outcome
Suppressing head impulse paradigm (SHIMP)
Time frame: 6 month
SHIMP equipment will objectively quantify change of vestibular function.
Subjective visual vertical (SVV)
Time frame: 6 month
SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function
Video head impulse test (v-HIT)
Time frame: 6 month
v-HIT equipment will objectively quantify change of vestibular function.
Dizziness handicap inventory (DHI) questionnaire
Time frame: 6 month
Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Vestibular Neuritis
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Measuring Vestibular Organ Function With Weak Alternating Current Stimulation
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Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
Vestibular Neuritis
Not yet recruiting
Quantitative Eye Movement Measurements in Patients with Acute Vestibular Syndrome
Acute Vestibular Syndrome, Vertigo
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.
Dan D Hougaard, MD principal investigator
Aalborg University Hospital
Martin H Wolder, MS principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular rehabilitation and Corticosteroid in people with Vestibular Neuritis, run by Aalborg University Hospital at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 29 Jul 2022. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suppressing head impulse paradigm (SHIMP) (time frame: 6 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2022.