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Telemedical Examination of a Three-Component Oculomotor Testing Battery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02938221
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):
Munich Municipal Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Stroke Vertigo Dizziness Device: Telemedical video-oculography system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility and Safety of a Telemedically Performed Three-Component Oculomotor Testing Battery (HINTS) in Healthy Adults
Study Start Date : October 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telemedical video-oculography
Execution of three oculomotor tests using a telemedical video-oculography system
Device: Telemedical video-oculography system
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 Outcome Measures :
  1. Number of evaluable telemedical oculomotor examinations [ Time Frame: through completion of diagnostic test, an average of 10 minutes ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02938221

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Klinikum München-Harlaching
Munich, Bavaria, Germany, 81545
Sponsors and Collaborators
Munich Municipal Hospital
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Principal Investigator: Gordian J Hubert, Dr. med. Städtisches Klinikum München GmbH
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Responsible Party: Munich Municipal Hospital Identifier: NCT02938221    
Other Study ID Numbers: TeleHINTS-1
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Munich Municipal Hospital:
Acute Vestibular Syndrome
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders