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The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

Primary Purpose

Benign Paroxysmal Positional Vertigo, BPPV, Vertigo

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
BPPV diagnostic
TRV chair
VNG goggles
IMU sensor
Manual BPPV diagnostics
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Benign Paroxysmal Positional Vertigo focused on measuring TRV reposition chair, Dix-Hallpike maneuver, Supine Roll Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age above 18 years Classic BPPV-patient history (short lasting (<1 minute) positional rotatory vertigo, no accompanying tinnitus or hearing loss, and no focal neurological findings. Understand written and spoken Danish Exclusion Criteria: Pregnancy Weight ≥ 150 kg and or Height ≥ 2m Neck and spine immobility to a degree where MD on examination bed is impossible Insufficient cooperation during diagnostic testing Sedative antihistamines taken within the past seven days Comorbidities: Heart failure (EF < 40), known cerebral aneurysm, cerebrovascular events (<3 months) or dissection disease Spontaneous or gaze evoked nystagmus

Sites / Locations

  • Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bedside BPPV diagnostics

TRV BPPV diagnostics

Arm Description

Diagnostics of BPPV with manual tests using VNG goggles. The goggles will be added an IMU sensor detecting angulation and velocity (the physician will not get feedback from the sensor during the examination. This will only be used in later analysis).

Diagnostics of BPPV using the TRV chair.

Outcomes

Primary Outcome Measures

Diagnostic Accuracy
Sensitivity, specificity, positive predictive value and negative predictive value of bedside examination (index-test). Gold standard is diagnostics in the TRV chair.

Secondary Outcome Measures

Head angulation during diagnostic bedside examination.
Angulation of the head during diagnostic bedside examination will be measured using an IMU sensor. Data will be presented as the difference in head angulation compared to the ideal angulation descriped for the diagnostic tests.
Angular velocity during diagnostic bedside examination
Angular velocity of the head movements during diagnostic bedside examination will be measured using an IMU sensor. Data will be presented as mean velocity and peak velocity.

Full Information

First Posted
April 17, 2023
Last Updated
May 8, 2023
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05846711
Brief Title
The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.
Official Title
The Accuracy of Manual BPPV Diagnostics: A Randomized Crossover Study With Comparison of Manual Diagnostic and Diagnostic in TRV Chair, When Using VNG Goggles in Both Scenarios.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

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
No

5. Study Description

Brief Summary
The aim is to investigate the accuracy of manual diagnostics of benign paroxysmal positional vertigo (BPPV) by comparing it to BPPV diagnostics in mechanical rotational chair (TRV chair). VNG (videonystagmography) goggles will be used in both scenarios. Furthermore, the investigators will examine the importance of angulation and velocity in relation to the diagnostic outcome.
Detailed Description
Open-label, randomized controlled trial with cross over comparing manual bedside BPPV diagnostics with diagnostics in a mechanical rotational chair (TRV chair) when using VNG goggles in both scenarios. Patients with a history of positional vertigo will be considered for enrollment and randomized to which diagnostic modality they begin with. Each subject will wait for minimum 30 minutes between the two diagnostics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo, BPPV, Vertigo, Vestibular Disorder, Vestibular Diseases, Labyrinth Diseases, Inner Ear Disease
Keywords
TRV reposition chair, Dix-Hallpike maneuver, Supine Roll Test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
203 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bedside BPPV diagnostics
Arm Type
Active Comparator
Arm Description
Diagnostics of BPPV with manual tests using VNG goggles. The goggles will be added an IMU sensor detecting angulation and velocity (the physician will not get feedback from the sensor during the examination. This will only be used in later analysis).
Arm Title
TRV BPPV diagnostics
Arm Type
Active Comparator
Arm Description
Diagnostics of BPPV using the TRV chair.
Intervention Type
Diagnostic Test
Intervention Name(s)
BPPV diagnostic
Intervention Description
Supine Roll Test and Dix-Hallpike Test
Intervention Type
Device
Intervention Name(s)
TRV chair
Intervention Description
Mechanical rotational chair
Intervention Type
Device
Intervention Name(s)
VNG goggles
Intervention Description
Goggles for video nystagmography
Intervention Type
Device
Intervention Name(s)
IMU sensor
Intervention Description
A sensor that measures triaxial acceleration and triaxial angular velocity.
Intervention Type
Procedure
Intervention Name(s)
Manual BPPV diagnostics
Intervention Description
Bedside BPPV diagnostics
Primary Outcome Measure Information:
Title
Diagnostic Accuracy
Description
Sensitivity, specificity, positive predictive value and negative predictive value of bedside examination (index-test). Gold standard is diagnostics in the TRV chair.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Head angulation during diagnostic bedside examination.
Description
Angulation of the head during diagnostic bedside examination will be measured using an IMU sensor. Data will be presented as the difference in head angulation compared to the ideal angulation descriped for the diagnostic tests.
Time Frame
2 year
Title
Angular velocity during diagnostic bedside examination
Description
Angular velocity of the head movements during diagnostic bedside examination will be measured using an IMU sensor. Data will be presented as mean velocity and peak velocity.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age above 18 years Classic BPPV-patient history (short lasting (<1 minute) positional rotatory vertigo, no accompanying tinnitus or hearing loss, and no focal neurological findings. Understand written and spoken Danish Exclusion Criteria: Pregnancy Weight ≥ 150 kg and or Height ≥ 2m Neck and spine immobility to a degree where MD on examination bed is impossible Insufficient cooperation during diagnostic testing Sedative antihistamines taken within the past seven days Comorbidities: Heart failure (EF < 40), known cerebral aneurysm, cerebrovascular events (<3 months) or dissection disease Spontaneous or gaze evoked nystagmus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malene Hentze Hansen, MD
Phone
004531151838
Email
m.hentze@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malene Hentze Hansen, MD
Organizational Affiliation
Department of Otolaryngology, Head & Neck Surgery and Audiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
City
Aalborg
State/Province
North Denmark Region
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malene Hentze Hansen, MD
Phone
0045 31151838
Email
m.hentze@rn.dk
First Name & Middle Initial & Last Name & Degree
Malene Hentze Hansen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

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