The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Labyrinth Diseases; BPPV; Vertigo; Benign Paroxysmal Positional Vertigo; Vestibular Diseases; Vestibular Disorder; Inner Ear Disease
• Intervention / Treatment: Diagnostic test: BPPV diagnostic; Device: VNG goggles; Device: IMU sensor; Procedure: Manual BPPV diagnostics; Device: TRV chair

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.

• Study Type: Interventional
• Enrollment (Anticipated): 203
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malene Hentze Hansen, MD; Phone Number: 004531151838; Email: m.hentze@rn.dk

Study Locations

• Denmark
  • North Denmark Region
    • Aalborg, North Denmark Region, Denmark, 9000
      • Recruiting
      • Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
      • Contact: Malene Hentze Hansen, MD; Phone Number: 0045 31151838; Email: m.hentze@rn.dk
      • Principal Investigator: Malene Hentze Hansen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TRV BPPV diagnostics; Diagnostics of BPPV using the TRV chair.	Diagnostic test: BPPV diagnostic; Supine Roll Test and Dix-Hallpike Test; Device: VNG goggles; Goggles for video nystagmography; Device: TRV chair; Mechanical rotational chair
Active Comparator: Bedside BPPV diagnostics; 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).	Diagnostic test: BPPV diagnostic; Supine Roll Test and Dix-Hallpike Test; Device: VNG goggles; Goggles for video nystagmography; Device: IMU sensor; A sensor that measures triaxial acceleration and triaxial angular velocity.; Procedure: Manual BPPV diagnostics; Bedside BPPV diagnostics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy	Sensitivity, specificity, positive predictive value and negative predictive value of bedside examination (index-test). Gold standard is diagnostics in the TRV chair.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 year
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.	2 year

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Malene Hentze Hansen, MD, Department of Otolaryngology, Head & Neck Surgery and Audiology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: TRV reposition chair; Dix-Hallpike maneuver; Supine Roll Test
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Sensation Disorders; Otitis; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness; Vestibular Diseases; Ear Diseases; Labyrinthitis; Labyrinth Diseases
• Other Study ID Numbers: 20220061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No