search
Back to results

Autonomous Syncope Onset Prediction and Prevention

Primary Purpose

Syncope

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tilt table Erigo®
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syncope

Eligibility Criteria

18 Years - 49 Years (Adult)Accepts Healthy Volunteers

Inclusion Criteria:

  • healthy

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    tilt table Erigo®

    Arm Description

    observation of physiological parameters, tilting table with onset of syncope

    Outcomes

    Primary Outcome Measures

    clinical sign of syncope
    as diagnosed by the medical staff

    Secondary Outcome Measures

    Full Information

    First Posted
    November 27, 2015
    Last Updated
    October 3, 2019
    Sponsor
    Swiss Federal Institute of Technology
    Collaborators
    University of Zurich
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02684539
    Brief Title
    Autonomous Syncope Onset Prediction and Prevention
    Official Title
    Autonomous Syncope Onset Prediction and Prevention An Open-label, One-centre Pilot Study on Healthy Subjects With the Erigo Tilt Table
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    project weill not be realized for organisational reasons
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Swiss Federal Institute of Technology
    Collaborators
    University of Zurich

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    syncope prediction on tilt table
    Detailed Description
    A tilt table is used to provoke syncope. syncope prediction is achieved through sensor measurements (ECG, ICG, SpO2, breathing rate, BP, NIRS, GSR, oculography).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Syncope

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tilt table Erigo®
    Arm Type
    Experimental
    Arm Description
    observation of physiological parameters, tilting table with onset of syncope
    Intervention Type
    Device
    Intervention Name(s)
    tilt table Erigo®
    Intervention Description
    tilting table with onset of syncope
    Primary Outcome Measure Information:
    Title
    clinical sign of syncope
    Description
    as diagnosed by the medical staff
    Time Frame
    1 session of 90 minutes duration

    10. Eligibility

    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy Exclusion Criteria: -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Autonomous Syncope Onset Prediction and Prevention

    We'll reach out to this number within 24 hrs