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CompletedNCT03643354Updated May 16, 2023

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

An interventional study of Epley maneuver/Barbeque maneuver in Benign Paroxysmal Positional Vertigo, sponsored by University of Zurich. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by University of Zurich · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
453
Allocation
Not applicable
Sex
All
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Study 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.

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Conditions studied

  • Benign Paroxysmal Positional Vertigo
03

In context

Benign Paroxysmal Positional Vertigo

75 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.

This study's enrollment of 453 is above the median of 75 across 61 interventional studies indexed under Benign Paroxysmal Positional Vertigo.

Browse Benign Paroxysmal Positional Vertigo studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,048 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
453 participants (actual)

Study arms

  • 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.

    Diagnostic Test: Epley maneuver/Barbeque maneuver

Interventions

  • Diagnostic testEpley 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.

06

What researchers measure

Primary outcomes

  1. Prevalence of BPPV

    subjects

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

Secondary outcomes

  1. Evaluation of predictive Factors

    Questionnaire answers

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

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Study locations

1 site
  • Stefan Yu Boegli
    Zurich, Switzerland
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References and documents

Publications

  • 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. PubMed 35151262 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Jan 2023, 49 months.

Of 34 non-industry interventional studies with no phase under Benign Paroxysmal Positional Vertigo, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 49 months is above that.

Counting every sponsor, half of 35 studies reached it within 16 months; a quarter within 8 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2018
First posted
Aug 22, 2018
StartActual
Nov 25, 2018
Primary completionActual
Jan 1, 2023
CompletionActual
Apr 1, 2023
Last update
May 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03643354
Responsible party
Sponsor
First posted
Aug 22, 2018
Start date
Nov 25, 2018
Primary completion
Jan 1, 2023
Completion
Apr 1, 2023
Last update
May 16, 2023

Study contacts

n6iqtwqp Y Bögli
principal investigator · University of Zurich

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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