Back to resultsDifferent Treatments With the TRV Reposition Chair
Primary Purpose
Benign Paroxysmal Positional Vertigo
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Type of repositional maneuvre
Sponsored by
About this trial
This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring TRV Reposition Chair, Epley Maneuvre
Eligibility Criteria
Inclusion Criteria:
- Age above 18 years of age
- Medical history compatible with BPPV
- Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.
Exclusion Criteria:
- Former treatment with a repositional Chair
- Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair
Sites / Locations
- Department of Otolaryngology, Head & Neck Surgery and Audiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Posterior canalolithiasis
Lateral cupulolithiasis
Arm Description
Type of repositional maneuvre
Type of repositional maneuvre
Outcomes
Primary Outcome Measures
Evaluation by VNG Measurements
Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.
Subjective vertigo
A systematic registration of experienced vertigo during each diagnostic procedure will take place.
Secondary Outcome Measures
Dizziness Handicap Inventory (DHI) questionnaire
Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03541018
Brief Title
Different Treatments With the TRV Reposition Chair
Official Title
Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (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
To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.
Detailed Description
Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
TRV Reposition Chair, Epley Maneuvre
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posterior canalolithiasis
Arm Type
Experimental
Arm Description
Type of repositional maneuvre
Arm Title
Lateral cupulolithiasis
Arm Type
Experimental
Arm Description
Type of repositional maneuvre
Intervention Type
Procedure
Intervention Name(s)
Type of repositional maneuvre
Intervention Description
Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV
Primary Outcome Measure Information:
Title
Evaluation by VNG Measurements
Description
Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.
Time Frame
2 years
Title
Subjective vertigo
Description
A systematic registration of experienced vertigo during each diagnostic procedure will take place.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Dizziness Handicap Inventory (DHI) questionnaire
Description
Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age above 18 years of age
Medical history compatible with BPPV
Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.
Exclusion Criteria:
Former treatment with a repositional Chair
Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan D Hougaard, MD
Organizational Affiliation
Aalborg University Hospital, Denmark
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
Different Treatments With the TRV Reposition Chair
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