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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
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Benign Paroxysmal Positional Vertigo

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 13, 2018
Last Updated
May 11, 2023
Sponsor
University of Zurich
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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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