NCT03643354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
453

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 25, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

4.1 years

First QC Date

August 13, 2018

Last Update Submit

May 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of BPPV

    subjects

    Subjects (outcome measure) are assessed during the first 4 Years

Secondary Outcomes (1)

  • Evaluation of predictive Factors

    Is assessed after all subjects have been tested (after 5 Years)

Study Arms (1)

Evaluation of prevalence of BPPV

EXPERIMENTAL

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.

Diagnostic Test: Epley maneuver/Barbeque maneuver

Interventions

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

Evaluation of prevalence of BPPV

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Lives in retirement home/has vertigo/has signed the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stefan Yu Boegli

Zurich, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • n6iqtwqp Y Bögli

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 22, 2018

Study Start

November 25, 2018

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations