Clinical trial NCT05853328: Comparison of EM and SM+ Maneuvers in Patients With BPPV
Official title: Benign Peripheral Paroxysmal Positional Vertigo (BPPV): Comparison of the Epley Maneuver With the So-called SémontPLUS Liberation Maneuver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPPV
Keywords: Benign paroxysmal positional vertigo
SemontPLUS maneuver
Epley maneuver
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to one of two test groups. After being randomized to the SM+ arm or the EM arm, patients will receive one initial maneuver from a physician, then subsequently performe self-maneuvers at home three times in the morning, three times at noon and three times in the evening.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of days until no positional vertigo could be induced
timeFrame: 28 days
Secondary outcomes:
measure: Effect of the single maneuver performed by the physician.
timeFrame: 28 days
Other outcomes:
Locations:
city: Oostende
country: Belgium
facility: Department of ENT, AZ Sint-Jan Brugge-Oostende AV
state: Flanders
city: Munich
country: Germany
facility: Department of Neurology, Ludwig Maximilian University
state: Bavaria
city: Siena
country: Italy
facility: Department of ENT, University of Siena
Study officials:
affiliation: LMU University
name: Michael Strupp
role: PRINCIPAL_INVESTIGATOR
References: