American University of Beirut
Beirut, Lebanon
Location status: Recruiting
NCT Number: NCT07111000
The goal of this randomized controlled trial is to evaluate the efficacy of the Epley maneuver versus a sham maneuver in treating patients presenting to the emergency department (ED) with BPPV. The main questions that the study aims to answer are:
* What is the mean difference in Dizziness Handicap Inventory (DHI) scores between patients receiving the Epley maneuver and those receiving the sham maneuver 3 days after enrollment? * What is the immediate response (using a 0-10-point Likert scale) of patients in each arm of the study? * What is the proportion of patients who, despite agreeing to participate, were unable to complete the full Epley maneuver due to symptom severity?
Researchers will compare the Epley maneuver arm to the sham maneuver arm to see if the Epley maneuver is more effective in reducing BPPV symptoms.
Participants will:
* Undergo either the Epley maneuver or a sham maneuver. * Complete the Dizziness Handicap Inventory (DHI) questionnaire at baseline and 3 days post-discharge. * Patients with insufficient improvement in the sham maneuver group will receive a rescue Epley maneuver. * Have their vertigo severity assessed using a 0-10 point Likert scale at baseline, immediately and post-maneuver.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beirut, Lebanon
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The patient's head is turned 45 degrees towards the side that caused the most nystagmus or reproduced their initial symptoms. The patient is then laid down with their head hanging over the edge of the bed. After that, the head will be rotated 90 degrees in the opposite direction, with the head remaining in a dependent position. The patient is then asked to roll onto their side with their head facing downward. They are then brought back to a sitting position and the head is moved forward 45 degrees. Each position is held until the vertigo and/or nystagmus subsides or for at least 30 seconds
This control maneuver will involve coordinated movements of the hands and legs, while excluding any head movement. Patients will be at first in a sitting position with both feet on the ground and both hands placed on the thighs and then they will be asked to lift both hands off the thighs, keeping the arms extended. They will then be asked to return to their initial upright sitting position. Patients will then raise their right foot off the ground while keeping the left one planted on the ground. It will be an alternating movement between lifting the right and left feet while maintaining a smooth and well- controlled rhythm for 90 seconds.
Time frame: 3 days
The study will compare the average Dizziness Handicap Inventory score change from baseline to day 3 between the Epley maneuver group and the sham maneuver group. The DHI is a 25-item self-administered questionnaire designed to assess the effects of dizziness on various aspects of life, including functional, emotional, and physical domains. Scores range from 0, indicating no disability, to 100, representing severe disability. This scale enables patients to indicate how much dizziness interferes with their daily activities. A higher score reflects a greater perceived handicap caused by dizziness.
Time frame: 15-30 minutes after intervention
The severity of vertigo will be evaluated using both a 0 to 10-point Likert scale before and after applying the Epley/Sham maneuver.
Time frame: 3 days
Calculate the proportion of patients in each arm of the study who return to the ED.
Time frame: 15 minutes
The percentage of patients who agreed to participate but could not complete the Epley maneuver due to the severity of their symptoms.
Contact information is provided by the study sponsor or research team.
American University of Beirut Medical Center
Other
Evaluating the Efficacy of Epley Maneuver in the Treatment of Benign Paroxysmal Positional Vertigo in the Emergency Department: A Randomized Controlled Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07491965
Avitaminosis, Benign Paroxysmal Positional Vertigo
Sohag, Egypt
View Trial DetailsNCT06643702
Benign Paroxysmal Positional Vertigo, Benign Paroxysmal Positional Vertigo (BPPV)
Saltsjö-Boo, Stockholm County, Sweden
View Trial DetailsNCT06625281
Benign Paroxysmal Positional Vertigo, Benign Paroxysmal Positional Vertigo (BPPV)
Islamabad, Pakistan
View Trial DetailsNCT05984901
Benign Paroxysmal Positional Vertigo, Benign Paroxysmal Positional Vertigo (BPPV)
Norwich, Norfolk, United Kingdom
View Trial Details