- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03643354
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes
May 11, 2023 updated by: University of Zurich
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy in Retirement Homes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
453
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stefan Bögli, pract. med.
- Phone Number: +41795063196
- Email: stefanyu.boegli@usz.ch
Study Locations
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-
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Zürich, Switzerland
- Stefan Yu Boegli
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Evaluation of prevalence of BPPV
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.
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Subjects will be rotated using the Rotundum Device to perform the previously described maneuvers Epley/Barbeque to evaluate the presence of BPPV.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of BPPV
Time Frame: Subjects (outcome measure) are assessed during the first 4 Years
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subjects
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Subjects (outcome measure) are assessed during the first 4 Years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of predictive Factors
Time Frame: Is assessed after all subjects have been tested (after 5 Years)
|
Questionnaire answers
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Is assessed after all subjects have been tested (after 5 Years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: n6iqtwqp Y Bögli, University of Zurich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 25, 2018
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
April 1, 2023
Study Registration Dates
First Submitted
August 13, 2018
First Submitted That Met QC Criteria
August 20, 2018
First Posted (Actual)
August 22, 2018
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 11, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BPPV Retirement Homes
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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