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NCT03643354 Clinical Trial

Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy in Retirement Homes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03643354
Other study ID # BPPV Retirement Homes
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2018
Est. completion date April 1, 2023

Study information
Verified date May 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 453
Est. completion date April 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

  • Benign Paroxysmal Positional Vertigo
  • Vertigo

Intervention

Diagnostic Test:
• Epley maneuver/Barbeque maneuver
Subjects will be rotated using the Rotundum Device to perform the previously described maneuvers Epley/Barbeque to evaluate the presence of BPPV.

Locations
Country Name City State
Switzerland Stefan Yu Boegli Zürich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of BPPV subjects Subjects (outcome measure) are assessed during the first 4 Years
Secondary Evaluation of predictive Factors Questionnaire answers Is assessed after all subjects have been tested (after 5 Years)
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