Skip to main content
OpenTrials
Completed

NCT Number: NCT02938221

Telemedical Examination of a Three-Component Oculomotor Testing Battery

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consenting adults

Exclusion criteria

  • Acute vertigo or dizziness, acute neck pain, history of stroke, history of acute vestibular syndrome, strong unilateral or bilateral visual impairment, complete movement restriction of cervical spine

Treatment and study plan

Telemedical video-oculography system

Device

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)

Primary outcomes

  1. Number of evaluable telemedical oculomotor examinations

    Time frame: through completion of diagnostic test, an average of 10 minutes

Secondary outcomes

  1. Accuracy of telemedical oculomotor examination (correlation to bedside test)

    Time frame: through completion of diagnostic test, an average of 10 minutes

  2. Number of participants with adverse or serious adverse events that are related to telemedical oculomotor examination

    Time frame: through completion of diagnostic test, an average of 10 minutes

  3. Time delay of telemedical tests

    Time frame: through completion of diagnostic test, an average of 10 minutes

Sponsors and collaborators

Lead sponsor

Munich Municipal Hospital

Other

Registry information

Official study title

Feasibility and Safety of a Telemedically Performed Three-Component Oculomotor Testing Battery (HINTS) in Healthy Adults

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2016
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.