Autonomous Syncope Onset Prediction and Prevention
Primary Purpose
Syncope
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tilt table Erigo®
Sponsored by
About this trial
This is an interventional diagnostic trial for Syncope
Eligibility Criteria
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
NCT ID
NCT02684539
First Posted
November 27, 2015
Last Updated
October 3, 2019
Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Zurich
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Withdrawn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
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