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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

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

NCT ID

NCT03643354

First Posted

August 13, 2018

Last Updated

May 11, 2023

Sponsor

University of Zurich

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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