Benign Paroxysmal Positional VertigoNCT03643354
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes
A study testing Epley maneuver/Barbeque maneuver in people with Benign Paroxysmal Positional Vertigo, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Epley maneuver/Barbeque maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Nov 2018to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lives in retirement home/has vertigo/has signed the informed consent
Who cannot join
- severe heart failure
- untreated cardiac arrythmia
- severe autonomic Dysregulation
- untreated epilepsy
- untreated cervical vertebral body fracture
- inability to follow the test
Show all 11Show fewer
- weight over 150kg or under 40kg
- height below 140cm or over 200cm
- bedridden
- already participated this study
- participant is connected to the study team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy in Retirement Homes
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.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Epley maneuver/Barbeque maneuver
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epley maneuver/Barbeque maneuverDiagnostic test
Subjects will be rotated using the Rotundum Device to perform the previously described maneuvers Epley/Barbeque to evaluate the presence of BPPV.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Epley maneuver/Barbeque maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of BPPV
subjects
Measured: Subjects (outcome measure) are assessed during the first 4 Years
Secondary outcomes (1)
Evaluation of predictive Factors
Questionnaire answers
Measured: Is assessed after all subjects have been tested (after 5 Years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start25 Nov 2018
- Primary completion1 Jan 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- n6iqtwqp Y Bögli, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643354
- Sponsor's protocol ID
- BPPV Retirement Homes
- Status last verified
- May 2023
- First submitted
- 13 Aug 2018
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy in Retirement Homes
- ClinicalTrials.gov ID
- NCT03643354
- Acronym / sponsor ID
- BPPV Retirement Homes
- Conditions
- Benign Paroxysmal Positional Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of prevalence of BPPV | Experimental | Diagnostic Test: Epley maneuver/Barbeque maneuverEpley/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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Lives in retirement home/has vertigo/has signed the informed consent
Key exclusion criteria (11 listed)
- severe heart failure
- untreated cardiac arrythmia
- severe autonomic Dysregulation
- untreated epilepsy
- untreated cervical vertebral body fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epley maneuver/Barbeque maneuverSubjects will be rotated using the Rotundum Device to perform the previously described maneuvers Epley/Barbeque to evaluate the presence of BPPV. | Diagnostic test | Evaluation of prevalence of BPPV |
Primary outcome
Prevalence of BPPV
Time frame: Subjects (outcome measure) are assessed during the first 4 Years
subjects
1 secondary outcome
Evaluation of predictive Factors
Time frame: Is assessed after all subjects have been tested (after 5 Years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 35151262Muller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
n6iqtwqp Y Bögli principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epley maneuver/Barbeque maneuver in people with Benign Paroxysmal Positional Vertigo, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of BPPV (time frame: Subjects (outcome measure) are assessed during the first 4 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03643354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.