Telemedical Examination of a Three-Component Oculomotor Testing Battery

Recruiting

Phase N/A Results N/A

Trial Description

The study investigates the feasibility and safety of the telemedical implementation of three diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing system. The testing battery comprises Halmagyi's head impulse test, test for nystagmus and test of skew (vertical misalignment) known as the HINTS protocol. Previously published data have shown high sensitivity and specificity of the protocol for the discrimination of central and peripheral causes of acute vestibular syndrome. In this study the three tests will be executed on 30 healthy subjects using video goggles (EyeSeeCam, Interacoustics GmbH, Germany) connected to a mobile wireless-workstation for bidirectional audiovisual communication in a clinical environment (MEYTEC GmbH, Germany). A newly developed remote control and video conferencing solution allows the execution and evaluation of the HINTS protocol in a telemedical setup.
The examination is guided by a remote physician using the help of a trained assistant attending to the subject. Corresponding clinical bedside tests will be executed for comparison. Primary endpoint is feasibility of the three diagnostic tests in a telemedical setting. Safety as well as accuracy of the telemedical versus bedside examination will be analyzed as secondary outcome measures. Aim of the study is to improve diagnostic accuracy for patients with acute vestibular syndrome in remote areas where specialists are rare.

Conditions

Interventions

  • Telemedical video-oculography system Device
    Intervention Desc: Telemedical video-oculography setup consisting of video goggles (EyeSeeCam, Interacoustics GmbH, Germany), a mobile telemedical workstation and an extended conferencing and remote control system (MEYTEC GmbH, Germany)
    ARM 1: Kind: Experimental
    Label: Telemedical video-oculography
    Description: Execution of three oculomotor tests using a telemedical video-oculography system

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of evaluable telemedical oculomotor examinations through completion of diagnostic test, an average of 10 minutes No
Secondary Accuracy of telemedical oculomotor examination (correlation to bedside test) through completion of diagnostic test, an average of 10 minutes No
Secondary Number of participants with adverse or serious adverse events that are related to telemedical oculomotor examination through completion of diagnostic test, an average of 10 minutes Yes
Secondary Time delay of telemedical tests through completion of diagnostic test, an average of 10 minutes No

Sponsors