Comparison of EM and SM+ Maneuvers in Patients With BPPV

Not Applicable

Completed

• Conditions: BPPV

• Registration Number: NCT05853328
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

Objective of this prospective randomized treatment trial is to compare the effectiveness of the SemontPLUS (SM+) with the Epley maneuver (EM) for the therapy of posterior canal benign paroxysmal positional vertigo canalolithiasis (pcBPPV).

Detailed Description

BPPV is the second most common form of vertigo. Reported prevalence ranges from 10 to 140 per 100,000 and lifetime prevalence is at least 2.4%; prevalence of 9-11% have been found in a population older than 75 years.

The leading symptom is recurrent attacks of spinning vertigo, each triggered by changes in position relative to gravity and lasting from seconds to one minute. The cause is usually freely moving otoconia in the posterior arcuate canal (so-called canalolithiasis); the horizontal canal is affected much less frequently. In 70% of patients there is a spontaneous remission within days. In case of persistence, about 95% of patients can be successfully treated with so-called freeing maneuvers, e.g., the Sémont maneuver. However, this often requires 20 to 30 maneuvers over several days.

Based on

1. our own biophysical studies, which we performed together with colleagues from Switzerland on a mechanical model of positional vertigo and which show that theoretically 24 the effectiveness of the Sémont maneuvers can be increased by changing the positional angle by 30° in the so-called step two of the positional maneuvers, as well as

2. an analysis of the comparison of the conventional Sémont maneuver with the so-called SémontPLUS maneuver, which shows that the mean time to freedom from symptoms for the Sémont maneuver is 3.9 days and only 2.3 days for the SémontPLUS maneuver (p\<0.05), the efficacy of the Epley maneuver will be compared with the SemontPLUS maneuver in a parallel group design.

The primary endpoint is the duration, i.e., days ("mornings") until freedom from symptoms with continuation of the two maneuvers in the following days, three times in the morning, at noon and in the evening. This is assessed by the patient's statements that he/she can still induce rotational vertigo or not during the positioning maneuvers to the affected side performed by him/herself.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2022-03-10
• Study Completion: 2022-04-07
• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-10
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Subject (≥ 18 years of age) meets diagnostic criteria for the current presence of BPPV of a posterior arcuate duct (8):

History: rotary vertigo attacks triggered by head or body position change. Duration: < 1 minute, associated with nausea, vomiting, oscillopsia

Findings: When positioned to the affected ear: torsional and vertically to the forehead beating, exhaustive nystagmus with crescendo-decrescendo-like course.

Exclusion Criteria

• Subjects not capable of giving consent
• Respondent does not want therapy for BPPV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of days until no positional vertigo could be induced	28 days	Patients had to document whether they could provoke positional vertigo every morning. The primary endpoint was the number of days until no positional vertigo could be induced on three subsequent mornings.

Secondary Outcome Measures

Name	Time	Method
Effect of the single maneuver performed by the physician.	28 days	How many patients in both treatment groups become vertigo and nystagmus-free after a single performance of the allocated treatment maneuver performed by a physician.

Trial Locations

Locations (3)

Department of ENT, AZ Sint-Jan Brugge-Oostende AV; 🇧🇪 Oostende, Flanders, Belgium

Department of Neurology, Ludwig Maximilian University; 🇩🇪 Munich, Bavaria, Germany

Department of ENT, University of Siena; 🇮🇹 Siena, Italy