BPPVNCT05969340
Detecting Otoconia With CT-Scan
A study testing ultra-high-resolution CT-scan in people with BPPV, run by Academisch Ziekenhuis Maastricht.
Trial summary
Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the patient to experience short episodes of vertigo when there are changes in head position. The current theory on the causes of BPPV is the displacement of the otoconia from the otolith organ to the semicircular canal organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BPPV
- What is being tested?
- ultra-high-resolution CT-scan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Mar 2025
- 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
- Experimental Group:
- Diagnosed with Posterior canal BPPV.
- Age 18 or older.
- Clear nystagmus consistent with canal direction and stimulation.
- Mild or greater complaints (none, mild, moderate, severe).
- Crescendo decrescendo nystagmus pattern.
Show all 10Show fewer
- Slow phase eye velocity ≥ 15 deg/sec.
- Control Group:
- Scheduled for CI implantation CT scan.
- Age 18 or older.
Who cannot join
- Experimental Group:
- Anterior or lateral canal BPPV.
- Inability to undergo CRM and DH maneuvers.
- Central vestibular disorders.
- Multi-canal BPPV or subjective BPPV.
- Pregnancy.
Show all 12Show fewer
- Control Group:
- BPPV, central vestibular disorders, multicanal BPPV, subjective BPPV.
- Ossifying labyrinthitis, DFNA9, obstructive vestibular schwannoma on MRI.
- Normal VHIT or history of meningitis.
- Pregnancy or other vestibular pathologies.
- Past history of BPPV.
About this study
Official title: Detecting Otoconia Using Ultra-high Resolution CT-imaging in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the patient to experience short episodes of vertigo when there are changes in head position. The current theory on the causes of BPPV is the displacement of the otoconia from the otolith organ to the semicircular canal organs. BPPV's current treatments consist of repositioning maneuvers to readjust the location of the otoconia back to its original place. Even though the treatments are highly successful in many cases, this study, if proven successful, will help confirm this theory and will help diagnose complicated cases where BPPV is recurrent and treatment has been unsuccessful.
Read the detailed description
Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the patient to experience vertigo when there are changes in head position. The prevalence is estimated to account for 20-30% of all vertigo diagnoses in a specialized clinic (von Brevern et al., 2007). The current theory on the cause of BPPV is the displacement of otoconia from the otolith organ to the semicircular canal organs due to gravitational forces.
Current treatments for BPPV consist of repositioning maneuvers to readjust the location of the otoconia back to its original place (von Brevern et al., 2015). Even though the treatment is highly successful in many cases patients still have recurrent (26%) or persistent (4%) symptoms (Dorigueto et al., 2009), and objective confirmation of the disease is warranted. Until now, visualization and confirmation of the presence of otoliths have not been successful in clinical practice. This is largely due to the very small size of the otoliths in a small inner ear structure, requiring sensitive and ultra-high-resolution imaging.
In 2021, a study was performed in Japan using 3 Dimensional Computed Tomography (3D CT) scans to detect the otoconia inside the horizontal canal. It compared scans of people with BPPV in the horizontal canal and healthy individuals (Yamane et al., 2021). The authors were able to visualize otoconia-like substance inside the canal in all 10 out of 10 affected patients and 6 out of 10 of the healthy participants in at least one ear (Yamane et al., 2021). In this study, the investigators will image the patients temporal bone with an ultra-high-resolution CT-scan (Benson et al.2022). They will focus on imaging the posterior canal for BPPV, and compare it with the imaging of individuals who do not have BPPV. In addition, they will compare the imaging of the canal pre and post-treatment using the Epley maneuver.
- Conditions
- BPPV
- Being tested
- ultra-high-resolution CT-scan
- Keywords
- BPPV, Otoconia, ultra-high resolution CT-imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-high-resolution CT-scanDiagnostic test
Use of ultra-high-resolution CT-scan to detect otoconia in the posterior canal BPPV
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patient diagnosed with Posterior canal BPPV Receives: Diagnostic Test: ultra-high-resolution CT-scan |
| Control group | Placebo comparator | Patient who are scheduled for CT-imaging as part of standard clinical routine and do not have BPPV Receives: Diagnostic Test: ultra-high-resolution CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualisation of presence or absence of otoconia in the posterior semicircular canal by comparing patient with confirmed BPPV symptoms compared to control subjects without BPPV
The presence or absence of otoconia in the posterior semicircular canal will be assessed qualitatively and semi-quantitatively using the CT parameters for BPPV patients, and the radiological images will be compared to those of control subjects.
Measured: up to 1 hour
Secondary outcomes (1)
Visualization of the presence or absence of otoconia in patients with confirmed Benign Paroxysmal Positional Vertigo (BPPV) symptoms before and after a repositioning procedure.
Change in position of the otoconia will be assessed qualitatively and semi-quantitively using the CT parameters in BPPV patients by comparing the radiological images before and after repositioning maneuver (Epley)
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Why it stopped: The study is still in the planning stage, undergoing protocol reconsideration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BPPVStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups involved: * The experimental group * The control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Melliti, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969340
- Sponsor's protocol ID
- NL 83124.068.22
- Status last verified
- Apr 2024
- First submitted
- 14 Jul 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
PubMed 17135456von Brevern M, Bertholon P, Brandt T, Fife T, Imai T, Nuti D, Newman-Toker D. Benign paroxysmal positional vertigo: Diagnostic criteria. J Vestib Res. 2015;25(3-4):105-17. doi: 10.3233/VES-150553.
PubMed 26756126Dorigueto RS, Mazzetti KR, Gabilan YP, Gananca FF. Benign paroxysmal positional vertigo recurrence and persistence. Braz J Otorhinolaryngol. 2009 Jul-Aug;75(4):565-72. doi: 10.1016/s1808-8694(15)30497-3.
PubMed 19784427Yamane H, Konishi K, Anniko M. Visualization of horizontal canal benign paroxysmal positional vertigo using 3DCT imaging and its assessment. Acta Otolaryngol. 2021 May;141(5):482-489. doi: 10.1080/00016489.2021.1892822. Epub 2021 Mar 29.
PubMed 33781168Rajendran K, Voss BA, Zhou W, Tao S, DeLone DR, Lane JI, Weaver JM, Carlson ML, Fletcher JG, McCollough CH, Leng S. Dose Reduction for Sinus and Temporal Bone Imaging Using Photon-Counting Detector CT With an Additional Tin Filter. Invest Radiol. 2020 Feb;55(2):91-100. doi: 10.1097/RLI.0000000000000614.
PubMed 31770297Benson JC, Rajendran K, Lane JI, Diehn FE, Weber NM, Thorne JE, Larson NB, Fletcher JG, McCollough CH, Leng S. A New Frontier in Temporal Bone Imaging: Photon-Counting Detector CT Demonstrates Superior Visualization of Critical Anatomic Structures at Reduced Radiation Dose. AJNR Am J Neuroradiol. 2022 Apr;43(4):579-584. doi: 10.3174/ajnr.A7452. Epub 2022 Mar 24.
PubMed 35332019
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Otoconia Using Ultra-high Resolution CT-imaging in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo
- ClinicalTrials.gov ID
- NCT05969340
- Acronym / sponsor ID
- NL 83124.068.22
- Conditions
- BPPV
- Keywords
- BPPV, Otoconia, ultra-high resolution CT-imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is still in the planning stage, undergoing protocol reconsideration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 1 Aug 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.
Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the patient to experience short episodes of vertigo when there are changes in head position. The current theory on the causes of BPPV is the displacement of the otoconia from the otolith organ to the semicircular canal organs. BPPV's current treatments consist of repositioning maneuvers to readjust the location of the otoconia back to its original place. Even though the treatments are highly successful in many cases, this study, if proven successful, will help confirm this theory and will help diagnose complicated cases where BPPV is recurrent and treatment has been unsuccessful.
Detailed description
Benign Paroxysmal Positional Vertigo (BPPV) is a benign inner ear disease that causes the patient to experience vertigo when there are changes in head position. The prevalence is estimated to account for 20-30% of all vertigo diagnoses in a specialized clinic (von Brevern et al., 2007). The current theory on the cause of BPPV is the displacement of otoconia from the otolith organ to the semicircular canal organs due to gravitational forces.
Current treatments for BPPV consist of repositioning maneuvers to readjust the location of the otoconia back to its original place (von Brevern et al., 2015). Even though the treatment is highly successful in many cases patients still have recurrent (26%) or persistent (4%) symptoms (Dorigueto et al., 2009), and objective confirmation of the disease is warranted. Until now, visualization and confirmation of the presence of otoliths have not been successful in clinical practice. This is largely due to the very small size of the otoliths in a small inner ear structure, requiring sensitive and ultra-high-resolution imaging.
In 2021, a study was performed in Japan using 3 Dimensional Computed Tomography (3D CT) scans to detect the otoconia inside the horizontal canal. It compared scans of people with BPPV in the horizontal canal and healthy individuals (Yamane et al., 2021). The authors were able to visualize otoconia-like substance inside the canal in all 10 out of 10 affected patients and 6 out of 10 of the healthy participants in at least one ear (Yamane et al., 2021). In this study, the investigators will image the patients temporal bone with an ultra-high-resolution CT-scan (Benson et al.2022). They will focus on imaging the posterior canal for BPPV, and compare it with the imaging of individuals who do not have BPPV. In addition, they will compare the imaging of the canal pre and post-treatment using the Epley maneuver.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are 2 groups involved: * The experimental group * The control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: ultra-high-resolution CT-scanPatient diagnosed with Posterior canal BPPV |
| Control group | Placebo comparator | Diagnostic Test: ultra-high-resolution CT-scanPatient who are scheduled for CT-imaging as part of standard clinical routine and do not have BPPV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with Posterior canal BPPV.
- Age 18 or older.
- Clear nystagmus consistent with canal direction and stimulation.
- Mild or greater complaints (none, mild, moderate, severe).
- Crescendo decrescendo nystagmus pattern.
Key exclusion criteria (12 listed)
- Anterior or lateral canal BPPV.
- Inability to undergo CRM and DH maneuvers.
- Central vestibular disorders.
- Multi-canal BPPV or subjective BPPV.
- Pregnancy.
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 |
|---|---|---|
| ultra-high-resolution CT-scanUse of ultra-high-resolution CT-scan to detect otoconia in the posterior canal BPPV | Diagnostic test | Control group, Experimental group |
Primary outcome
Visualisation of presence or absence of otoconia in the posterior semicircular canal by comparing patient with confirmed BPPV symptoms compared to control subjects without BPPV
Time frame: up to 1 hour
The presence or absence of otoconia in the posterior semicircular canal will be assessed qualitatively and semi-quantitatively using the CT parameters for BPPV patients, and the radiological images will be compared to those of control subjects.
1 secondary outcome
Visualization of the presence or absence of otoconia in patients with confirmed Benign Paroxysmal Positional Vertigo (BPPV) symptoms before and after a repositioning procedure.
Time frame: up to 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 17135456von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
- Background: PubMed 26756126von Brevern M, Bertholon P, Brandt T, Fife T, Imai T, Nuti D, Newman-Toker D. Benign paroxysmal positional vertigo: Diagnostic criteria. J Vestib Res. 2015;25(3-4):105-17. doi: 10.3233/VES-150553.
- Background: PubMed 19784427Dorigueto RS, Mazzetti KR, Gabilan YP, Gananca FF. Benign paroxysmal positional vertigo recurrence and persistence. Braz J Otorhinolaryngol. 2009 Jul-Aug;75(4):565-72. doi: 10.1016/s1808-8694(15)30497-3.
- Background: PubMed 33781168Yamane H, Konishi K, Anniko M. Visualization of horizontal canal benign paroxysmal positional vertigo using 3DCT imaging and its assessment. Acta Otolaryngol. 2021 May;141(5):482-489. doi: 10.1080/00016489.2021.1892822. Epub 2021 Mar 29.
- Background: PubMed 31770297Rajendran K, Voss BA, Zhou W, Tao S, DeLone DR, Lane JI, Weaver JM, Carlson ML, Fletcher JG, McCollough CH, Leng S. Dose Reduction for Sinus and Temporal Bone Imaging Using Photon-Counting Detector CT With an Additional Tin Filter. Invest Radiol. 2020 Feb;55(2):91-100. doi: 10.1097/RLI.0000000000000614.
- Background: PubMed 35332019Benson JC, Rajendran K, Lane JI, Diehn FE, Weber NM, Thorne JE, Larson NB, Fletcher JG, McCollough CH, Leng S. A New Frontier in Temporal Bone Imaging: Photon-Counting Detector CT Demonstrates Superior Visualization of Critical Anatomic Structures at Reduced Radiation Dose. AJNR Am J Neuroradiol. 2022 Apr;43(4):579-584. doi: 10.3174/ajnr.A7452. Epub 2022 Mar 24.
- Individual participant dataSharing planned: Undecided
Related trials for BPPV
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV)
Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
Benign Paroxysmal Positional Vertigo (BPPV)
Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ultra-high-resolution CT-scan in people with BPPV, run by Academisch Ziekenhuis Maastricht.
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 10 inclusion and 12 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: withdrawn, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Visualisation of presence or absence of otoconia in the posterior semicircular canal by comparing patient with confirmed BPPV symptoms compared to control subjects without BPPV (time frame: up to 1 hour). 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 NCT05969340, which also lists 6 linked publications.
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 1 May 2024.