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A study to establish the efficacy of a new type of mechanical rotational chair in treating BPPV. In addition, comparison of three types of treatment maneuvers using the mechanical rotational chair.
Open-label, randomized controlled trial comparing three different treatment maneuvers in a mechanical rotational chair (ROTUNDUM-chair) in treating BPPV. Patients diagnosed with BPPV will be randomized to one of three maneuvers in the ROTUNDUM-chair:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epley's Maneuver | Active Comparator | Treatment of posterior canal BPPV with Epley's maneuver in the ROTUNDUM-chair. |
|
| Semont Maneuver | Experimental | Treatment of posterior canal BPPV with the Semont maneuver in the ROTUNDUM-chair. |
|
| 360 degree vertical rotation | Active Comparator | Treatment of posterior canal BPPV with a 360 degree vertical rotation in the ROTUNDUM-chair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epley's Maneuver | Procedure | Treatment with Epley's Maneuver in the ROTUNDUM-chair |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatments | Number of treatments necessary to achieve resolution of vertigo and nystagmus | 2 years |
| Treatment success after first treatment | Number of subjects achieving resolution of vertigo and nystagmus after one treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dizziness Handicap Inventory (DHI) questionnaire | Comparison of pre- and post-treatment score, total score between 0 and 100. Higher score reflects worse condition | 2 years |
| Adverse events | Registration of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan D Hougaard, MD | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology, Head & Neck Surgery and Audiology | Aalborg | North Denmark | 9000 | Denmark |
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| ID | Term |
|---|---|
| D065635 | Benign Paroxysmal Positional Vertigo |
| D014717 | Vertigo |
| D004244 | Dizziness |
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
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| Semont Maneuver |
| Procedure |
Treatment with the Semont Maneuver in the ROTUNDUM-chair |
|
| 360 degree vertical rotation | Procedure | Treatment with 360 degree vertical rotation in the ROTUNDUM-chair |
|
| 2 years |
| Value of liberatory nystagmus | Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success | 2 years |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012678 | Sensation Disorders |