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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03643354
Recruitment Status : Not yet recruiting
First Posted : August 22, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Benign Paroxysmal Positional Vertigo Diagnostic Test: Epley maneuver/Barbeque maneuver Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy in Retirement Homes
Estimated Study Start Date : November 25, 2018
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Prevalence of BPPV [ Time Frame: Subjects (outcome measure) are assessed during the first 4 Years ]
    subjects


Secondary Outcome Measures :
  1. Evaluation of predictive Factors [ Time Frame: Is assessed after all subjects have been tested (after 5 Years) ]
    Questionnaire answers



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643354


Contacts
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Contact: Stefan Bögli, pract. med. +41795063196 stefanyu.boegli@usz.ch

Sponsors and Collaborators
University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03643354    
Other Study ID Numbers: BPPV Retirement Homes
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vertigo
Benign Paroxysmal Positional Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases