Meniere DiseaseNCT04835688
Ventilation Tube Insertion for Unilateral Menière's Disease
A study testing Transmyringeal ventilation tube insertion in people with Meniere Disease, run by Casper Grønlund Larsen at 1 site in Denmark.
Trial summary
The purpose of this trial is to assess the effects of transmyringeal ventilation tubes compared with sham-treatment which do not ventilate the middle ear, on the number of vertigo attacks lasting more than 20 minutes in participants with Menière's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere Disease
- What is being tested?
- Transmyringeal ventilation tube insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Sep 2021to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with definite or probable unilateral Menière's disease according to the diagnostic criteria formulated by the Classification Committee of the Bárány Society, The Japan Society for Equilibrium Research, the European Academy of Otology and Neurotology (EAONO), the Equilibrium Committee of the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS), and the Korean Balance Society:
- Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours
- Audiometrically documented low- to medium-frequency sensorineural hearing loss in the affected ear on at least one occasion before, during or after one of the episodes of vertigo
- Fluctuating aural symptoms (hearing, tinnitus or fullness) in the affected ear
- Not better accounted for by another vestibular diagnosis
Who cannot join
- Bilateral Menière's disease
- Additional neurotological disorders (e.g. vestibular migraine, vertebrobasilar transient ischemic attack or acoustic neuroma)
- Previous surgical therapy such as intratympanic gentamicin or endolymphatic sac surgery
- Expected problems to adhere to the study protocol (dementia, non-fluent in Danish, substance abuse, etc.)
- Previous treatment with transmyringeal ventilation tubes after childhood
- A serious illness that might interfere with treatment or follow-up
Trial locations and contacts
1 site in 1 country.
Bjarki Djurhuus, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Køge, 4600
Casper Grønlund Larsen, MD, 47323800, caslar@regionsjaelland.dk
About this study
Official title: Transmyringeal Ventilation Tube Insertion for Unilateral Menière's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial
The purpose of this trial is to assess the effects of transmyringeal ventilation tubes compared with sham-treatment which do not ventilate the middle ear, on the number of vertigo attacks lasting more than 20 minutes in participants with Menière's disease.
Read the detailed description
Menière's disease is an inner ear disorder with recurrent attacks of vertigo, fluctuating sensorineural hearing loss, tinnitus, and aural fullness. The underlying pathogenetic mechanisms are not known. The pathologic-anatomic correlate of the disease is endolymphatic hydrops, i.e. distension of the endolymphatic spaces as seen at post-mortem microscopic examination of the temporal bone. Prevalence-figures are in the range between 0.1% to 0.5% in the population. In Denmark, the estimated prevalence of Menière's disease is 3500. The disease commonly begins in the fourth or fifth decade of life, and the prevalence increases with age.
There are a great number of different treatment options for Menière's disease including diuretics, sodium-restriction, beta-histidine, and psycho-supportive means, most of which are not validated. The only validated treatment for the vertigo attacks is chemical labyrinthectomy by intra-tympanic injections of the ototoxic antibiotic gentamicin for which two double-blind, placebo-controlled trials found a significant effect. Treatment with gentamicin is ablative, i.e. the goal of the treatment is to destroy the vestibular sensors of the affected ear. This carries a risk of long-standing unsteadiness alongside with permanent hearing loss in the treated ear. Still, no treatments seem to protect from the hearing loss associated with Menière's disease.
The first to advocate the use of transmyringeal ventilation tubes for Menière's disease was Tumarkin in 1966. Tumarkin et al. suggested that negative middle-ear pressure, due to poor tubal function, would lead to a relative over-pressure in the inner ear and that this might be one of the mechanisms behind Menière's disease. In addition, Tumarkin et al. presented several cases where treatment with transmyringeal tubes resulted in relief from vertigo attacks. Hall and Brackmann performed tympanometry in patients with Menière's disease and showed that some, but not all, patients had negative middle-ear pressure and they questioned Tumarkin's suggestions.
- Conditions
- Meniere Disease
- Being tested
- Transmyringeal ventilation tube insertion, Sham-treatment
- Keywords
- Ventilation tube insertion, Grommet insertion, Vertigo
- Medical subject headings
- Meniere Disease, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmyringeal ventilation tube insertionProcedure or surgery
Also called Ventilation tube insertion, grommet insertion
In both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon.
For the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted.
Sham-treatmentProcedure or surgery
For the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube.
| Study group | Role | What they receive |
|---|---|---|
| Ventilation tube insertion | Experimental | Ventilation tube insertion into the tympanic membrane. Receives: Procedure: Transmyringeal ventilation tube insertion |
| Sham-treatment | Sham comparator | Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion. Receives: Procedure: Sham-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of vertigo attacks lasting more than 20 minutes
Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.
Measured: 3 months
Number of vertigo attacks lasting more than 20 minutes
Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.
Measured: 24 months
Secondary outcomes (6)
Pure-tone audiometry
4 tone average of 500, 1000, 2000, and 3000 Hz (dB) and 3 tone average of 125, 250, and 500 Hz (dB).
Measured: 3 months
AAO-HNS Functional Level Scale
Questionnaire with written descriptions of how Menière's disease affects the life of the patient, from no impact at all to totally handicapped and unable to work.
Measured: 3 months
Hearing, tinnitus, unsteadiness and aural fullness
Patient-reported outcome by filling out a self-evaluation of symptoms-questionnaire.
Measured: 24 months
Number of subjects leaving
To check for unsatisfied treatment.
Measured: 24 months
Number of subjects satisfied
To check for satisfied treatment
Measured: 24 months
Speech audiometry
Discrimination in %.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start20 Sep 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 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 Meniere DiseaseStudies of the same condition, open and under way.
- 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
- A pro-spective, double-blinded, sham-controlled, randomized, clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casper Grønlund Larsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Casper Grønlund Larsen, Zealand University Hospital
- Investigators
- Casper Grønlund Larsen, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835688
- Sponsor's protocol ID
- CG1-2021
- Status last verified
- Sep 2021
- First submitted
- 6 Apr 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be shared upon reasonable request
Publications
Larsen CG, Karlberg M, Guldfred F, Devantier L, Maagaard M, Homoe P, Djurhuus BD. Transmyringeal ventilation tube insertion for unilateral Meniere's disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial. Trials. 2022 Oct 17;23(1):877. doi: 10.1186/s13063-022-06777-w.
PubMed 36253829
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmyringeal Ventilation Tube Insertion for Unilateral Menière's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT04835688
- Acronym / sponsor ID
- CG1-2021
- Conditions
- Meniere Disease
- Keywords
- Ventilation tube insertion, Grommet insertion, Vertigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Casper Grønlund LarsenUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 8 Apr 2021 (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.
The purpose of this trial is to assess the effects of transmyringeal ventilation tubes compared with sham-treatment which do not ventilate the middle ear, on the number of vertigo attacks lasting more than 20 minutes in participants with Menière's disease.
Detailed description
Menière's disease is an inner ear disorder with recurrent attacks of vertigo, fluctuating sensorineural hearing loss, tinnitus, and aural fullness. The underlying pathogenetic mechanisms are not known. The pathologic-anatomic correlate of the disease is endolymphatic hydrops, i.e. distension of the endolymphatic spaces as seen at post-mortem microscopic examination of the temporal bone. Prevalence-figures are in the range between 0.1% to 0.5% in the population. In Denmark, the estimated prevalence of Menière's disease is 3500. The disease commonly begins in the fourth or fifth decade of life, and the prevalence increases with age.
There are a great number of different treatment options for Menière's disease including diuretics, sodium-restriction, beta-histidine, and psycho-supportive means, most of which are not validated. The only validated treatment for the vertigo attacks is chemical labyrinthectomy by intra-tympanic injections of the ototoxic antibiotic gentamicin for which two double-blind, placebo-controlled trials found a significant effect. Treatment with gentamicin is ablative, i.e. the goal of the treatment is to destroy the vestibular sensors of the affected ear. This carries a risk of long-standing unsteadiness alongside with permanent hearing loss in the treated ear. Still, no treatments seem to protect from the hearing loss associated with Menière's disease.
The first to advocate the use of transmyringeal ventilation tubes for Menière's disease was Tumarkin in 1966. Tumarkin et al. suggested that negative middle-ear pressure, due to poor tubal function, would lead to a relative over-pressure in the inner ear and that this might be one of the mechanisms behind Menière's disease. In addition, Tumarkin et al. presented several cases where treatment with transmyringeal tubes resulted in relief from vertigo attacks. Hall and Brackmann performed tympanometry in patients with Menière's disease and showed that some, but not all, patients had negative middle-ear pressure and they questioned Tumarkin's suggestions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A pro-spective, double-blinded, sham-controlled, randomized, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Ventilation tube insertion | Experimental | Procedure: Transmyringeal ventilation tube insertionVentilation tube insertion into the tympanic membrane. |
| Sham-treatment | Sham comparator | Procedure: Sham-treatmentSham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with definite or probable unilateral Menière's disease according to the diagnostic criteria formulated by the Classification Committee of the Bárány Society, The Japan Society for Equilibrium Research, the European Academy of Otology and Neurotology (EAONO), the Equilibrium Committee of the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS), and the Korean Balance Society:
- Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours
- Audiometrically documented low- to medium-frequency sensorineural hearing loss in the affected ear on at least one occasion before, during or after one of the episodes of vertigo
- Fluctuating aural symptoms (hearing, tinnitus or fullness) in the affected ear
- Not better accounted for by another vestibular diagnosis
Key exclusion criteria (6 listed)
- Bilateral Menière's disease
- Additional neurotological disorders (e.g. vestibular migraine, vertebrobasilar transient ischemic attack or acoustic neuroma)
- Previous surgical therapy such as intratympanic gentamicin or endolymphatic sac surgery
- Expected problems to adhere to the study protocol (dementia, non-fluent in Danish, substance abuse, etc.)
- Previous treatment with transmyringeal ventilation tubes after childhood
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 |
|---|---|---|
| Transmyringeal ventilation tube insertionAlso: Ventilation tube insertion, grommet insertionIn both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon. For the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted. | Procedure or surgery | Ventilation tube insertion |
| Sham-treatmentFor the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube. | Procedure or surgery | Sham-treatment |
Primary outcome
Number of vertigo attacks lasting more than 20 minutes
Time frame: 3 months
Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.
Number of vertigo attacks lasting more than 20 minutes
Time frame: 24 months
Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.
6 secondary outcomes
Pure-tone audiometry
Time frame: 3 months
AAO-HNS Functional Level Scale
Time frame: 3 months
Hearing, tinnitus, unsteadiness and aural fullness
Time frame: 24 months
Number of subjects leaving
Time frame: 24 months
Number of subjects satisfied
Time frame: 24 months
Speech audiometry
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Derived from this study: PubMed 36253829Larsen CG, Karlberg M, Guldfred F, Devantier L, Maagaard M, Homoe P, Djurhuus BD. Transmyringeal ventilation tube insertion for unilateral Meniere's disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial. Trials. 2022 Oct 17;23(1):877. doi: 10.1186/s13063-022-06777-w.
- Individual participant dataSharing planned: Yes. Individual patient data will be shared upon reasonable request
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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.
Bjarki Djurhuus, MD, PhD contact
Casper Grønlund Larsen, MD principal investigator
Zealand 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 Transmyringeal ventilation tube insertion in people with Meniere Disease, run by Casper Grønlund Larsen 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 5 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: status not confirmed, as of the sponsor's last update on 14 Oct 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Casper Grønlund Larsen, MD (47 32 38 00, caslar@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of vertigo attacks lasting more than 20 minutes (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04835688, 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 Oct 2021.