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Telemedical Examination of a Three-Component Oculomotor Testing Battery

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ClinicalTrials.gov Identifier: NCT02938221
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : January 12, 2017
Sponsor:
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
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02938221


Locations
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Germany
Klinikum München-Harlaching
Munich, Bavaria, Germany, 81545
Sponsors and Collaborators
Munich Municipal Hospital
Investigators
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Principal Investigator: Gordian J Hubert, Dr. med. Städtisches Klinikum München GmbH

Publications:
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Responsible Party: Munich Municipal Hospital
ClinicalTrials.gov Identifier: NCT02938221     History of Changes
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:
TeleStroke
HINTS
Diagnosis
Telemedicine
Acute Vestibular Syndrome

Additional relevant MeSH terms:
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Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders