Vestibular NeuritisNEVRINGNCT04678167
Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
A study testing Caloric test, Measurement of the speed of Nystagmus and Angle of deviation at Fukuda in people with Vestibular Neuritis, run by University Hospital, Brest at 2 sites in France.
Trial summary
Vestibular neuritis is a brutal and continuous dizzying syndrome of peripheral (vestibular) origin without cochlear or other associated involvement. Specifically, vestibular neuritis is inflammation of the nerve that innervates the vestibular canals (the inner ear). 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?
- Caloric test, Measurement of the speed of Nystagmus and Angle of deviation at Fukuda
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Mar 2021to 10 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adult patients,
- patient with vestibular neuritis defined by appearance of continuous rotating vertigo with nausea
- patient with spontaneous horizonto-rotating nystagmus beating towards the healthy ear
- patient with a postural deviation towards the affected ear;
- vestibular hyporeflexia measured at the caloric tests greater than 25%
- patient who has given free, enlighten and written consent
Who cannot join
- patient with a history of vertigo of vestibular origin or with vertigo developing for more than 4 days
- patient with associated hearing loss or tinnitus
- patient with an motor ocular abnormality of central origin
- patient refusal or inability to consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 1 recruiting
- Recruiting
CHU de Brest
Brest, 29200
Jean-Christophe LECLERE, Dr, 02.98.22.33.78, jean-christophe.leclere@chu-brest.fr
- Terminated
CH Pays de Morlaix
Morlaix, 29672
About this study
Official title: Evaluation of the Efficacy of BOARDING RING Glasses in the Treatment of Vestibular Neuritis
Vestibular neuritis is a brutal and continuous dizzying syndrome of peripheral (vestibular) origin without cochlear or other associated involvement. Specifically, vestibular neuritis is inflammation of the nerve that innervates the vestibular canals (the inner ear). It is characterized by the sudden onset of intense and prolonged vertigo accompanied by postural imbalance, nausea and vomiting, without hearing impairment or other neurological symptoms. Vestibular neuritis is the second cause of peripheral vertigo after benign paroxysmal positional vertigo. It represents approximately 7% of patients consulting for vertigo. The purpose of this study is to evaluate if wearing Boarding Ring glasses can be accelerated vestibular compensation.
- Conditions
- Vestibular Neuritis
- Being tested
- Caloric test, Measurement of the speed of Nystagmus, Angle of deviation at Fukuda, Alexander's degree of nystagmus, EHTEV questionnaire
- Keywords
- vestibular hyporeflexia, rotational vertigo, horizontal-rotational nystagmus
- Medical subject headings
- Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric testDiagnostic test
Also called Barany test
Lying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity.
Measurement of the speed of NystagmusDiagnostic test
A helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests.
Angle of deviation at FukudaDiagnostic test
The patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda.
Alexander's degree of nystagmusDiagnostic test
there are 3 degrees:
- Degree I: nystagmus that exists only when the eyes are turned to the right.
- Degree II: also exists when the eyes are to the right or to the front.
- Degree Ill: exists when the eyes are on the right, front, or left
EHTEV questionnaireOther
Handicap Scale for Balance Disorders and Vertigo
EEV questionnaireOther
European Vertigo Assessment Questionnaire
anxiety VASOther
visual analog scale of anxiety
| Study group | Role | What they receive |
|---|---|---|
| Boarding ring glasses | Experimental | Realization of the following examinations WITH Boarding ring glasses :
* caloric tests,
* measurement of the speed of Nystagmus,
* angle of deviation in Fukuda,
* Alexander's degree of nystagmus,
* EHTEV and EEV questionnaires,
* anxiety VAS Receives: Diagnostic Test: Caloric test; Diagnostic Test: Measurement of the speed of Nystagmus; Diagnostic Test: Angle of deviation at Fukuda; Diagnostic Test: Alexander's degree of nystagmus; Other: EHTEV questionnaire; Other: EEV questionnaire; Other: anxiety VAS |
| Placebo glasses | Placebo comparator | Realization of the following examinations WITH Placebo glasses :
* caloric tests,
* measurement of the speed of Nystagmus,
* angle of deviation in Fukuda,
* Alexander's degree of nystagmus,
* EHTEV and EEV questionnaires,
* anxiety VAS Receives: Diagnostic Test: Caloric test; Diagnostic Test: Measurement of the speed of Nystagmus; Diagnostic Test: Angle of deviation at Fukuda; Diagnostic Test: Alexander's degree of nystagmus; Other: EHTEV questionnaire; Other: EEV questionnaire; Other: anxiety VAS |
| No glasses | Other | Realization of the following examinations WITHOUT glasses :
* caloric tests,
* measurement of the speed of Nystagmus,
* angle of deviation in Fukuda,
* Alexander's degree of nystagmus,
* EHTEV and EEV questionnaires,
* anxiety VAS Receives: Diagnostic Test: Caloric test; Diagnostic Test: Measurement of the speed of Nystagmus; Diagnostic Test: Angle of deviation at Fukuda; Diagnostic Test: Alexander's degree of nystagmus; Other: EHTEV questionnaire; Other: EEV questionnaire; Other: anxiety VAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).
Measured: 7 day
Secondary outcomes (8)
Speed of nystagmus
Measured: 1 year
Alexander's degree of nystagmus
Measure of the degree of intensity of nystagmus. There are 3 degrees :
- Degree I: nystagmus which exists only when the eyes are turned to the right.
- Degree II: also exists when the eyes are to the right or to the front.
- Degree Ill: exists when the eyes are on the right, front, or left.
Measured: 1 year
Duration of hospitalization (for hospitalized patients)
Measured: 1 year
Anxiety visual analog scale
0 = no anxiety, 10 = maximum anxiety imaginable
Measured: 1 year
Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)
It helps to determine the physical, emotional and functional difficulties experienced in everyday life. EHTEV questionnaire is scored on 100 points.
The physical score from 0 to 28 points, the emotional score from 0 to 36 points and the functional score from 0 to 36 points. ( 0 = no difficulty).
Measured: 1 year
European Vertigo Evaluation Scale (EEV questionnaire)
Makes it possible to quantify vertigo and the associated vestibular symptoms and to monitor their evolution. EEV questionnaire is scored on 20 points (0 = no symptoms, 20 = maximum symptoms)
Measured: 1 year
Vestibular deficit at caloric tests
measures 7of nystagmus (= fluttering of the eye) which reflects vestibular activity
Measured: 1 year
Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start10 Mar 2021
- Primary completion17 Mar 2028 (estimated)
- Study completion10 May 2029 (estimated)
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 University Hospital, BrestThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization list is established by the Brest CHRU data management unit before the start of the trial. Based on a ratio (1:1:1) with stratification on the center.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe LECLERE, Dr, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678167
- Sponsor's protocol ID
- 29BRC20.0040
- Acronym
- NEVRING
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2020
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of BOARDING RING Glasses in the Treatment of Vestibular Neuritis
- ClinicalTrials.gov ID
- NCT04678167
- Acronym / sponsor ID
- NEVRING / 29BRC20.0040
- Conditions
- Vestibular Neuritis
- Keywords
- vestibular hyporeflexia, rotational vertigo, horizontal-rotational nystagmus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 17 Mar 2028 (estimated)
- Study completion
- 10 May 2029 (estimated)
- First posted
- 21 Dec 2020 (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.
Vestibular neuritis is a brutal and continuous dizzying syndrome of peripheral (vestibular) origin without cochlear or other associated involvement. Specifically, vestibular neuritis is inflammation of the nerve that innervates the vestibular canals (the inner ear). It is characterized by the sudden onset of intense and prolonged vertigo accompanied by postural imbalance, nausea and vomiting, without hearing impairment or other neurological symptoms. Vestibular neuritis is the second cause of peripheral vertigo after benign paroxysmal positional vertigo. It represents approximately 7% of patients consulting for vertigo. The purpose of this study is to evaluate if wearing Boarding Ring glasses can be accelerated vestibular compensation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The randomization list is established by the Brest CHRU data management unit before the start of the trial. Based on a ratio (1:1:1) with stratification on the center.
| Arm | Type | Receives |
|---|---|---|
| Boarding ring glasses | Experimental | Diagnostic Test: Caloric test, Diagnostic Test: Measurement of the speed of Nystagmus, Diagnostic Test: Angle of deviation at Fukuda, Diagnostic Test: Alexander's degree of nystagmus, Other: EHTEV questionnaire, Other: EEV questionnaire, Other: anxiety VASRealization of the following examinations WITH Boarding ring glasses : * caloric tests, * measurement of the speed of Nystagmus, * angle of deviation in Fukuda, * Alexander's degree of nystagmus, * EHTEV and EEV questionnaires, * anxiety VAS |
| Placebo glasses | Placebo comparator | Diagnostic Test: Caloric test, Diagnostic Test: Measurement of the speed of Nystagmus, Diagnostic Test: Angle of deviation at Fukuda, Diagnostic Test: Alexander's degree of nystagmus, Other: EHTEV questionnaire, Other: EEV questionnaire, Other: anxiety VASRealization of the following examinations WITH Placebo glasses : * caloric tests, * measurement of the speed of Nystagmus, * angle of deviation in Fukuda, * Alexander's degree of nystagmus, * EHTEV and EEV questionnaires, * anxiety VAS |
| No glasses | Other | Diagnostic Test: Caloric test, Diagnostic Test: Measurement of the speed of Nystagmus, Diagnostic Test: Angle of deviation at Fukuda, Diagnostic Test: Alexander's degree of nystagmus, Other: EHTEV questionnaire, Other: EEV questionnaire, Other: anxiety VASRealization of the following examinations WITHOUT glasses : * caloric tests, * measurement of the speed of Nystagmus, * angle of deviation in Fukuda, * Alexander's degree of nystagmus, * EHTEV and EEV questionnaires, * anxiety VAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patients,
- patient with vestibular neuritis defined by appearance of continuous rotating vertigo with nausea
- patient with spontaneous horizonto-rotating nystagmus beating towards the healthy ear
- patient with a postural deviation towards the affected ear;
- vestibular hyporeflexia measured at the caloric tests greater than 25%
Key exclusion criteria (4 listed)
- patient with a history of vertigo of vestibular origin or with vertigo developing for more than 4 days
- patient with associated hearing loss or tinnitus
- patient with an motor ocular abnormality of central origin
- patient refusal or inability to consent
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 |
|---|---|---|
| Caloric testAlso: Barany testLying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity. | Diagnostic test | Boarding ring glasses, No glasses, Placebo glasses |
| Measurement of the speed of NystagmusA helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests. | Diagnostic test | Boarding ring glasses, No glasses, Placebo glasses |
| Angle of deviation at FukudaThe patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda. | Diagnostic test | Boarding ring glasses, No glasses, Placebo glasses |
| Alexander's degree of nystagmusthere are 3 degrees: * Degree I: nystagmus that exists only when the eyes are turned to the right. * Degree II: also exists when the eyes are to the right or to the front. * Degree Ill: exists when the eyes are on the right, front, or left | Diagnostic test | Boarding ring glasses, No glasses, Placebo glasses |
| EHTEV questionnaireHandicap Scale for Balance Disorders and Vertigo | Other | Boarding ring glasses, No glasses, Placebo glasses |
| EEV questionnaireEuropean Vertigo Assessment Questionnaire | Other | Boarding ring glasses, No glasses, Placebo glasses |
| anxiety VASvisual analog scale of anxiety | Other | Boarding ring glasses, No glasses, Placebo glasses |
Primary outcome
Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).
Time frame: 7 day
8 secondary outcomes
Speed of nystagmus
Time frame: 1 year
Alexander's degree of nystagmus
Time frame: 1 year
Duration of hospitalization (for hospitalized patients)
Time frame: 1 year
Anxiety visual analog scale
Time frame: 1 year
Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)
Time frame: 1 year
European Vertigo Evaluation Scale (EEV questionnaire)
Time frame: 1 year
Vestibular deficit at caloric tests
Time frame: 1 year
Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Vestibular Neuritis
Enrolling by invitation
Measuring Vestibular Organ Function With Weak Alternating Current Stimulation
Vestibular Disorder, Vestibular Schwannoma
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.
Jean-Christophe LECLERE, Dr principal investigator
University Hospital, Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric test, Measurement of the speed of Nystagmus and Angle of deviation at Fukuda in people with Vestibular Neuritis, run by University Hospital, Brest at 2 sites in France.
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 6 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe LECLERE, Dr (02.98.22.33.78, jean-christophe.leclere@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7). (time frame: 7 day). 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 19 Mar 2026.