Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04147156
Other study ID # ROTDUNDUM1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 27, 2020
Est. completion date January 1, 2022

Study information

Verified date July 2022
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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: 1. Epley's maneuver 2. Semont maneuver 3. 360 degree vertical rotation


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Characteristic (for BPPV) positional nystagmus - Positive Dix-Hallpike Test - Medical history compatible with BPPV Exclusion Criteria: - Treatment in a mechanical rotational chair within the last 6 months - Exclusion of BPPV diagnosis - Lack of treatment cooperation - Known cerebral aneurism or cerebral hemorrhage - Treated for BPPV within the past month

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Epley's Maneuver
Treatment with Epley's Maneuver in the ROTUNDUM-chair
Semont Maneuver
Treatment with the Semont Maneuver in the ROTUNDUM-chair
360 degree vertical rotation
Treatment with 360 degree vertical rotation in the ROTUNDUM-chair

Locations

Country Name City State
Denmark Department of Otolaryngology, Head & Neck Surgery and Audiology Aalborg North Denmark Region

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatments Number of treatments necessary to achieve resolution of vertigo and nystagmus 2 years
Primary Treatment success after first treatment Number of subjects achieving resolution of vertigo and nystagmus after one treatment 2 years
Secondary 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
Secondary Adverse events Registration of adverse events 2 years
Secondary Value of liberatory nystagmus Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05013671 - Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls N/A
Not yet recruiting NCT04436783 - Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo N/A
Recruiting NCT05634902 - Implementation of Evidence-Based Practice for Dizziness N/A
Withdrawn NCT05969340 - Detecting Otoconia With CT-Scan N/A
Completed NCT05853328 - Comparison of EM and SM+ Maneuvers in Patients With BPPV N/A
Not yet recruiting NCT05863949 - Clinical Trial of Vit D and Calcium for Recurrent BPPV N/A
Recruiting NCT06228196 - Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
Completed NCT05960786 - Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand N/A
Completed NCT05575362 - Comparison of Epley Maneuver and COW Thorne Cooksey Exercise With Half Somersault Maneuver in BPPV N/A
Recruiting NCT05834452 - Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair. N/A
Completed NCT05846711 - The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles. N/A
Completed NCT03871413 - TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo N/A