Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04436783
Other study ID # REB19-1367
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 14, 2022
Est. completion date October 1, 2023

Study information

Verified date June 2021
Source University of Calgary
Contact Reza Tabanfar, MD
Phone 5879683027
Email rezatabanfar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults (over 18 years old) - Clinical diagnosis of posterior semicircular canal benign paroxysmal positional vertigo Exclusion Criteria: - Hemodynamically unstable - Cervical spine instability - Limited neck range of motion

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

References & Publications (7)

Gopinath 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. — View Citation

Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8. — View Citation

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. Review. — View Citation

Kuo CH, Pang L, Chang R. Vertigo - part 1 - assessment in general practice. Aust Fam Physician. 2008 May;37(5):341-7. — View Citation

Neuhauser 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. Erratum in: Arch Intern Med. 2009 Jan 12;169(1):89. — View Citation

Strupp 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. — View Citation

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. Epub 2006 Nov 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Self reported once immediately before performing the Epley maneuver and once immediately after - in both arms
Secondary 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). Reported once immediately before performing the Epley maneuver and once immediately after - in both arms
See also
  Status Clinical Trial Phase
Recruiting NCT05013671 - Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls N/A
Recruiting NCT05634902 - Implementation of Evidence-Based Practice for Dizziness N/A
Withdrawn NCT05969340 - Detecting Otoconia With CT-Scan N/A
Completed NCT05853328 - Comparison of EM and SM+ Maneuvers in Patients With BPPV N/A
Not yet recruiting NCT05863949 - Clinical Trial of Vit D and Calcium for Recurrent BPPV N/A
Recruiting NCT06228196 - Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
Completed NCT04147156 - Efficacy of a New Type of Mechanical Rotational Chair in Treating BPPV N/A
Completed NCT05960786 - Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand N/A
Completed NCT05575362 - Comparison of Epley Maneuver and COW Thorne Cooksey Exercise With Half Somersault Maneuver in BPPV N/A
Recruiting NCT05834452 - Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair. N/A
Completed NCT05846711 - The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles. N/A
Completed NCT03871413 - TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo N/A