Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes
Primary Purpose
Benign Paroxysmal Positional Vertigo
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Epley maneuver/Barbeque maneuver
Sponsored by
About this trial
This is an interventional health services research trial for Benign Paroxysmal Positional Vertigo
Eligibility Criteria
Inclusion Criteria:
- Lives in retirement home/has vertigo/has signed the informed consent
Exclusion Criteria:
- severe heart failure
- untreated cardiac arrythmia
- severe autonomic Dysregulation
- untreated epilepsy
- untreated cervical vertebral body fracture
- inability to follow the test
- weight over 150kg or under 40kg
- height below 140cm or over 200cm
- bedridden
- already participated this study
- participant is connected to the study team
Sites / Locations
- Stefan Yu Boegli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluation of prevalence of BPPV
Arm Description
Epley/Barbeque maneuver will be performed using the Rotundum Device to assess if subject has BPPV, patient will thereafter be treated for it using the Rotundum Device.
Outcomes
Primary Outcome Measures
Prevalence of BPPV
subjects
Secondary Outcome Measures
Evaluation of predictive Factors
Questionnaire answers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03643354
Brief Title
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes
Official Title
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy in Retirement Homes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2018 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Benign paroxysmal positional vertigo (BPPV) is one of the most common types of vertigo, especially in elderly. Therefore the investigators have set the goal to evaluate the prevalence of BPPV and its therapy using the Rotundum device in elderly living in retirement homes. Furthermore the investigators use a questionnaire to evaluate possible predictive signs to improve the diagnosis of this disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
453 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluation of prevalence of BPPV
Arm Type
Experimental
Arm Description
Epley/Barbeque maneuver will be performed using the Rotundum Device to assess if subject has BPPV, patient will thereafter be treated for it using the Rotundum Device.
Intervention Type
Diagnostic Test
Intervention Name(s)
Epley maneuver/Barbeque maneuver
Intervention Description
Subjects will be rotated using the Rotundum Device to perform the previously described maneuvers Epley/Barbeque to evaluate the presence of BPPV.
Primary Outcome Measure Information:
Title
Prevalence of BPPV
Description
subjects
Time Frame
Subjects (outcome measure) are assessed during the first 4 Years
Secondary Outcome Measure Information:
Title
Evaluation of predictive Factors
Description
Questionnaire answers
Time Frame
Is assessed after all subjects have been tested (after 5 Years)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lives in retirement home/has vertigo/has signed the informed consent
Exclusion Criteria:
severe heart failure
untreated cardiac arrythmia
severe autonomic Dysregulation
untreated epilepsy
untreated cervical vertebral body fracture
inability to follow the test
weight over 150kg or under 40kg
height below 140cm or over 200cm
bedridden
already participated this study
participant is connected to the study team
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
n6iqtwqp Y Bögli
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stefan Yu Boegli
City
Zürich
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35151262
Citation
Muller R, Zangger P, Straumann D, Bogli SY. Dizziness and benign paroxysmal positional vertigo among retirement home residents: a cross-sectional descriptive and interventional study. BMC Geriatr. 2022 Feb 12;22(1):120. doi: 10.1186/s12877-022-02818-w.
Results Reference
derived
Learn more about this trial
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes
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