TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03871413|
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2019
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|BPPV||Device: TRV-chair Procedure: Manual repositioning maneuver||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Can Benign Paroxysmal Positional Vertigo (BPPV) be Treated Faster and More Efficiently by Using a Mechanical Rotational Chair Compared to the Traditional Manual Repositioning Maneuvers?|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
Active Comparator: Manual repositioning maneuver
Diagnostics and treatment of BPPV with manual repositioning maneuvers. In case of posterior canal involvement, Epley's maneuver will be used. In case of horizontal canal involvement, the log roll maneuver will be used.
Procedure: Manual repositioning maneuver
Treatment with manual repositioning maneuver
Experimental: Treatment in mechanical rotational chair (TRV-chair)
Diagnostics and treatment of BPPV with the use of a TRV chair. In case of posterior canal involvement, Epley's maneuver will be used with the addition of 10 kinetic impulses in each position.
In case of horizontal canal involvement, the log roll maneuver will be used with the addition of 10 kinetic impulses in each position.
Repositioning maneuvers in TRV-chair
- Number of treatments [ Time Frame: 2 years ]Number of treatment necessary to achieve resolution of vertigo and nystagmus
- Treatment success after first treatment [ Time Frame: 2 years ]Number of subjects achieving resolution of vertigo and nystagmus after one treatment
- Dizziness Handicap Inventory (DHI) questionnaire [ Time Frame: 2 years ]Comparison of pre-treatment score and post-treatment score
- Adverse events [ Time Frame: 2 years ]Registration of adverse events
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): NCT03871413
|Department of Otolaryngology, Head & Neck Surgery and Audiology|
|Aalborg, North Denmark Region, Denmark, 9000|
|Principal Investigator:||Dan D Hougaard, MD||Aalborg University Hospital|