Back to resultsTRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo
Primary Purpose
BPPV
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
TRV-chair
Manual repositioning maneuver
Sponsored by
About this trial
This is an interventional treatment trial for BPPV focused on measuring Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases, Epley Maneuver, TRV-chair, Repositioning chair
Eligibility Criteria
Inclusion Criteria:
- Characteristic (for BPPV) positional nystagmus
- Positive Dix-Hallpike
- Positive supine roll test
- Medical history compatible with BPPV
Exclusion Criteria:
- Treatment in TRV-chair within the last 6 months
- Exclusion of BPPV diagnosis
- Lack of treatment cooperation
- Known cerebral aneurism or cerebral hemorrhage
- Diagnosed and treated for BPPV within the past month
- Treatment with sedating anti-histamines within the past 7 days
Sites / Locations
- Department of Otolaryngology, Head & Neck Surgery and Audiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Manual repositioning maneuver
Treatment in mechanical rotational chair (TRV-chair)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of treatments
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Treatment success after first treatment
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Secondary Outcome Measures
Dizziness Handicap Inventory (DHI) questionnaire
Comparison of pre-treatment score and post-treatment score
Adverse events
Registration of adverse events
Full Information
NCT ID
NCT03871413
First Posted
March 8, 2019
Last Updated
July 22, 2020
Sponsor
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03871413
Brief Title
TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo
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?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV
Detailed Description
Open-label, randomized controlled trial comparing manual repositioning maneuvers with a mechanical rotational chair (TRV-chair) in diagnosing and treating BPPV. Patients with suspected BPPV will be randomized to either manual repositioning maneuvers or the TRV-chair.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPPV
Keywords
Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases, Epley Maneuver, TRV-chair, Repositioning chair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual repositioning maneuver
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment in mechanical rotational chair (TRV-chair)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TRV-chair
Intervention Description
Repositioning maneuvers in TRV-chair
Intervention Type
Procedure
Intervention Name(s)
Manual repositioning maneuver
Intervention Description
Treatment with manual repositioning maneuver
Primary Outcome Measure Information:
Title
Number of treatments
Description
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Time Frame
2 years
Title
Treatment success after first treatment
Description
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Dizziness Handicap Inventory (DHI) questionnaire
Description
Comparison of pre-treatment score and post-treatment score
Time Frame
2 years
Title
Adverse events
Description
Registration of adverse events
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Characteristic (for BPPV) positional nystagmus
Positive Dix-Hallpike
Positive supine roll test
Medical history compatible with BPPV
Exclusion Criteria:
Treatment in TRV-chair within the last 6 months
Exclusion of BPPV diagnosis
Lack of treatment cooperation
Known cerebral aneurism or cerebral hemorrhage
Diagnosed and treated for BPPV within the past month
Treatment with sedating anti-histamines within the past 7 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan D Hougaard, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Head & Neck Surgery and Audiology
City
Aalborg
State/Province
North Denmark Region
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo
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