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

65
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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
4mo left

Started Sep 2025

Status
not yet 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 Progress70%
Sep 2025Aug 2026

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
24 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2026

Last Updated

August 8, 2025

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

August 6, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

Benign Paroxysmal Positional Vertigo (BPPV), vertigo, Epley maneuver, Dix-Hallpike Test (DHT)

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.

    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
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+)
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. Patients who are able to understand and provide a signed informed consent to participate in the study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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
SINGLE GROUP
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

September 1, 2025

Primary Completion (Estimated)

July 22, 2026

Study Completion (Estimated)

August 22, 2026

Last Updated

August 8, 2025

Record last verified: 2024-12