NCT07111000

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Aug 2024Aug 2026

Study Start

First participant enrolled

August 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 6, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2026

Expected
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

August 6, 2025

Last Update Submit

May 6, 2026

Conditions

Keywords

Epleyvertigobening paroxysmal positional vertigo

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Epley

    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.

    3 days

Secondary Outcomes (3)

  • Immediate response of patients

    15-30 minutes after intervention

  • Rate of bounce-back to the ED

    3 days

  • Proportion of patients unable to undergo the full Epley maneuver

    15 minutes

Study Arms (2)

Epley Maneuver

EXPERIMENTAL

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

Procedure: Epley Maneuver

Sham Maneuver

SHAM COMPARATOR

This 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.

Procedure: Sham maneuver

Interventions

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

Epley Maneuver
Sham maneuverPROCEDURE

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.

Sham Maneuver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: above 18 years old
  • Patients presenting to the ED with symptoms of BPPV (single or recurrent episodes of vertigo lasting up to 2 minutes) and a positive DHT (episode of vertigo associated with torsional upbeating nystagmus) indicating a posterior semicircular canal BPPV.

You may not qualify if:

  • Severe cervical diseases (e.g., soft tissue disorders, cervical spondylosis, prolapsed intervertebral disks and severe rheumatoid arthritis with cervical instability …)
  • Unstable cardiovascular diseases (e.g., hemodynamically unstable, decompensated heart failure, acute myocardial infarction, decompensated valvular diseases, severe arrhythmias …)
  • Suspected vertebrobasilar diseases (e.g., cerebellar signs, vision changes, numbness or tingling in the extremities, slurred speech, changes in mental status, confusion …)
  • History of high-grade carotid stenosis
  • Recent (\<24 hours) intake of aminoglycosides, chemotherapeutic agents, cyclophosphamide, loop diuretics, or quinines
  • Patients with peripheral causes of vertigo other than BPPV (such as Meniere's disease or vestibular neuritis)
  • Patients with central causes of vertigo (vestibular migraine, Arnold Chiari malformation, history of CNS tumor(s), multiple sclerosis)
  • Patients with focal deficits on neurological exam
  • Patients with an episode of vertigo lasting more than 2 minutes
  • Patients with a negative DHT
  • Patients with pure horizontal or vertical nystagmus
  • Patients with lateral and anterior semicircular canals BPPV
  • Participants refusing to undergo Epley maneuver
  • Pregnancy beyond the 24th week of gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Eveline Hitti, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Specialty

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 8, 2025

Study Start

August 1, 2024

Primary Completion

July 22, 2026

Study Completion (Estimated)

August 22, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations