Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853328
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2023-05-02
Brief Title:
Comparison of EM and SM Maneuvers in Patients With BPPV
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Benign Peripheral Paroxysmal Positional Vertigo BPPV Comparison of the Epley Maneuver With the So-called SémontPLUS Liberation Maneuver
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 100000 and lifetime prevalence is at least 24 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 eg 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 39 days and only 23 days for the SémontPLUS maneuver p005 the efficacy of the Epley maneuver will be compared with the SemontPLUS maneuver in a parallel group design
The primary endpoint is the duration ie 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 patients statements that heshe can still induce rotational vertigo or not during the positioning maneuvers to the affected side performed by himherself
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 eg 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 39 days and only 23 days for the SémontPLUS maneuver p005 the efficacy of the Epley maneuver will be compared with the SemontPLUS maneuver in a parallel group design
The primary endpoint is the duration ie 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 patients statements that heshe can still induce rotational vertigo or not during the positioning maneuvers to the affected side performed by himherself
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None