BPPVNCT04436783
Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo
A study testing Virtual Reality Epley Maneuver System (VREMS) and Instructional Handout (IH) in people with BPPV and Vertigo, Peripheral, run by University of Calgary.
Trial summary
Background and Rationale: Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, affecting 2.4% of the general population and 30% of those over 70 years old. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BPPV, Vertigo, Peripheral
- What is being tested?
- Virtual Reality Epley Maneuver System (VREMS) and Instructional Handout (IH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2022to 1 Oct 2023
- 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
- Adults (over 18 years old)
- Clinical diagnosis of posterior semicircular canal benign paroxysmal positional vertigo
Who cannot join
- Hemodynamically unstable
- Cervical spine instability
- Limited neck range of motion
Trial locations and contacts
No sites are listed yet.
About this study
Background and Rationale:
Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, affecting 2.4% of the general population and 30% of those over 70 years old. The main symptom is the perceived sensation of movement of the surrounding or self, without actual such movement, triggered by changes in position (positional vertigo). It can be dangerous as repetitive symptoms can lead to falls and depression, particularly in the elderly. Additionally, at least half of those with initial symptoms of BPPV will have ongoing symptoms if not treated. The Epley maneuver is a particle-repositioning maneuver that is used to treat posterior semicircular canal BPPV, the most common type of BPPV, after a diagnosis has been made on physical examination. In-office administration of the Epley maneuver by a specialist yields a 90% success rate at treating the condition; however, at-home administration is much less successful. In a previous paper we demonstrated the development and face validation of a Virtual Reality Epley Maneuver System (VREMS) for performing the Epley maneuver correctly. In this study we aim to apply VREMS treatment in patients who have been diagnosed with BPPV.
Read more
Research Question and Objectives:
PICO (Patient/Population Intervention Compare Outcome): In adult patients diagnosed with posterior canal BPPV by a specialist, does VREMS, as compared to self-performed Epley maneuver using an instructional handout (IH) result in improved or resolved symptoms?
Methods:
Vertigo patients referred to the Neurovestibular Clinic will be evaluated by an Ear, Nose and Throat (ENT) specialist. Those who are diagnosed with posterior canal BPPV after history and physical examination including the Dix-Hallpike test will be approached to be recruited into the study. Patients who consent to participating in the study will be allocated to either the VREMS cohort or the control cohort. Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted or based on reading the IH. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver. All patients will also be asked to complete the NASA Task Load Index (NASA-TLX) to gauge their perceived mental workload. They will also be given an opportunity to give free-text feedback. For any patient with residual BPPV symptoms following Epley maneuver with VREMS or IH, the ENT specialist/vestibular physiotherapist will perform the Epley maneuver to ensure resolution of symptoms if possible prior to discharge from the clinic. The primary outcome of the study will be the improvement in and resolution of BPPV symptoms with VREMS use as compared to IH. Secondary outcome will be mental workload in each of the study arms.
- Conditions
- BPPV, Vertigo, Peripheral
- Being tested
- Virtual Reality Epley Maneuver System (VREMS), Instructional Handout (IH)
- Keywords
- BPPV, Vertigo, Peripheral vestibular disorder, Virtual reality
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Epley Maneuver System (VREMS)Device
The VREMS system includes a smartphone placed inside virtual reality goggles worn by the participant. On the smartphone there is a virtual reality application. When viewed through the VR goggles the participants see a three-dimensional environment. Audio and text cues are presented in a 3D environment to help guide the patient through the Epley maneuver.
Instructional Handout (IH)Other
Patients randomized to the IH group will be given an instructional handout with image and text-based instructions on the steps involved in performing the Epley maneuver. They will then be given the chance to perform the Epley maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Epley Maneuver System - VREMS | Experimental | Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver Receives: Device: Virtual Reality Epley Maneuver System (VREMS) |
| Instructional Handout (IH) | Active comparator | Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. They will be given a chance to review the IH, and then they will have a chance to perform the Epley maneuver. Receives: Other: Instructional Handout (IH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective dizziness
Patient reported dizziness score out of 10 - Min value 0(no dizziness) and max value 10 (completely debilitating dizziness). The higher the score, the greater the subjective dizziness (worse outcome).
Measured: Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms
Secondary outcomes (1)
Mental demand
Mental demand reported using the National Aeronautics and Space Administration (NASA) - Task Load Index - Minimum score 0 (no mental demand) and maximum score is 100 (very high mental demand). The higher the score, the greater the mental demand (worse outcome).
Measured: Reported once immediately before performing the Epley maneuver and once immediately after - in both arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start14 Nov 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BPPVStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Euna Hwang, University of Calgary
- Investigators
- Euna Hwang, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436783
- Sponsor's protocol ID
- REB19-1367
- Status last verified
- Jun 2021
- First submitted
- 26 May 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanley K, O'Dowd T, Considine N. A systematic review of vertigo in primary care. Br J Gen Pract. 2001 Aug;51(469):666-71.
PubMed 11510399Kuo CH, Pang L, Chang R. Vertigo - part 1 - assessment in general practice. Aust Fam Physician. 2008 May;37(5):341-7.
PubMed 18464964Strupp M, Brandt T. Diagnosis and treatment of vertigo and dizziness. Dtsch Arztebl Int. 2008 Mar;105(10):173-80. doi: 10.3238/arztebl.2008.0173. Epub 2008 Mar 7.
PubMed 19629221von 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 17135456Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8.
PubMed 430582Gopinath B, McMahon CM, Rochtchina E, Mitchell P. Dizziness and vertigo in an older population: the Blue Mountains prospective cross-sectional study. Clin Otolaryngol. 2009 Dec;34(6):552-6. doi: 10.1111/j.1749-4486.2009.02025.x.
PubMed 20070765Neuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of dizziness and vertigo in the community. Arch Intern Med. 2008 Oct 27;168(19):2118-24. doi: 10.1001/archinte.168.19.2118.
PubMed 18955641
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo
- ClinicalTrials.gov ID
- NCT04436783
- Acronym / sponsor ID
- REB19-1367
- Conditions
- BPPV, Vertigo, Peripheral
- Keywords
- BPPV, Vertigo, Peripheral vestibular disorder, Virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 14 Nov 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 18 Jun 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.
Background and Rationale:
Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, affecting 2.4% of the general population and 30% of those over 70 years old. The main symptom is the perceived sensation of movement of the surrounding or self, without actual such movement, triggered by changes in position (positional vertigo). It can be dangerous as repetitive symptoms can lead to falls and depression, particularly in the elderly. Additionally, at least half of those with initial symptoms of BPPV will have ongoing symptoms if not treated. The Epley maneuver is a particle-repositioning maneuver that is used to treat posterior semicircular canal BPPV, the most common type of BPPV, after a diagnosis has been made on physical examination. In-office administration of the Epley maneuver by a specialist yields a 90% success rate at treating the condition; however, at-home administration is much less successful. In a previous paper we demonstrated the development and face validation of a Virtual Reality Epley Maneuver System (VREMS) for performing the Epley maneuver correctly. In this study we aim to apply VREMS treatment in patients who have been diagnosed with BPPV.
Research Question and Objectives:
PICO (Patient/Population Intervention Compare Outcome): In adult patients diagnosed with posterior canal BPPV by a specialist, does VREMS, as compared to self-performed Epley maneuver using an instructional handout (IH) result in improved or resolved symptoms?
Methods:
Vertigo patients referred to the Neurovestibular Clinic will be evaluated by an Ear, Nose and Throat (ENT) specialist. Those who are diagnosed with posterior canal BPPV after history and physical examination including the Dix-Hallpike test will be approached to be recruited into the study. Patients who consent to participating in the study will be allocated to either the VREMS cohort or the control cohort. Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted or based on reading the IH. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver. All patients will also be asked to complete the NASA Task Load Index (NASA-TLX) to gauge their perceived mental workload. They will also be given an opportunity to give free-text feedback. For any patient with residual BPPV symptoms following Epley maneuver with VREMS or IH, the ENT specialist/vestibular physiotherapist will perform the Epley maneuver to ensure resolution of symptoms if possible prior to discharge from the clinic. The primary outcome of the study will be the improvement in and resolution of BPPV symptoms with VREMS use as compared to IH. Secondary outcome will be mental workload in each of the study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Epley Maneuver System - VREMS | Experimental | Device: Virtual Reality Epley Maneuver System (VREMS)Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver |
| Instructional Handout (IH) | Active comparator | Other: Instructional Handout (IH)Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. They will be given a chance to review the IH, and then they will have a chance to perform the Epley maneuver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (over 18 years old)
- Clinical diagnosis of posterior semicircular canal benign paroxysmal positional vertigo
Key exclusion criteria (3 listed)
- Hemodynamically unstable
- Cervical spine instability
- Limited neck range of motion
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 |
|---|---|---|
| Virtual Reality Epley Maneuver System (VREMS)The VREMS system includes a smartphone placed inside virtual reality goggles worn by the participant. On the smartphone there is a virtual reality application. When viewed through the VR goggles the participants see a three-dimensional environment. Audio and text cues are presented in a 3D environment to help guide the patient through the Epley maneuver. | Device | Virtual Reality Epley Maneuver System - VREMS |
| Instructional Handout (IH)Patients randomized to the IH group will be given an instructional handout with image and text-based instructions on the steps involved in performing the Epley maneuver. They will then be given the chance to perform the Epley maneuver. | Other | Instructional Handout (IH) |
Primary outcome
Subjective dizziness
Time frame: Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms
Patient reported dizziness score out of 10 - Min value 0(no dizziness) and max value 10 (completely debilitating dizziness). The higher the score, the greater the subjective dizziness (worse outcome).
1 secondary outcome
Mental demand
Time frame: Reported once immediately before performing the Epley maneuver and once immediately after - in both arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Background: PubMed 11510399Hanley K, O'Dowd T, Considine N. A systematic review of vertigo in primary care. Br J Gen Pract. 2001 Aug;51(469):666-71.
- Background: PubMed 18464964Kuo CH, Pang L, Chang R. Vertigo - part 1 - assessment in general practice. Aust Fam Physician. 2008 May;37(5):341-7.
- Background: PubMed 19629221Strupp M, Brandt T. Diagnosis and treatment of vertigo and dizziness. Dtsch Arztebl Int. 2008 Mar;105(10):173-80. doi: 10.3238/arztebl.2008.0173. Epub 2008 Mar 7.
- 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 430582Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8.
- Background: PubMed 20070765Gopinath B, McMahon CM, Rochtchina E, Mitchell P. Dizziness and vertigo in an older population: the Blue Mountains prospective cross-sectional study. Clin Otolaryngol. 2009 Dec;34(6):552-6. doi: 10.1111/j.1749-4486.2009.02025.x.
- Background: PubMed 18955641Neuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of dizziness and vertigo in the community. Arch Intern Med. 2008 Oct 27;168(19):2118-24. doi: 10.1001/archinte.168.19.2118.
- Individual participant dataSharing planned: No
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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.
Euna Hwang, MD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Epley Maneuver System (VREMS) and Instructional Handout (IH) in people with BPPV and Vertigo, Peripheral, run by University of Calgary.
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 2 inclusion and 3 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 16 Jun 2021. 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. 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 Reza Tabanfar, MD (5879683027, rezatabanfar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective dizziness (time frame: Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms). 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 NCT04436783, which also lists 7 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 16 Jun 2021.