Autonomous Syncope Onset Prediction and Prevention

Autonomous Syncope Onset Prediction and Prevention An Open-label, One-centre Pilot Study on Healthy Subjects With the Erigo Tilt Table

syncope prediction on tilt table

Study Overview

• Status: Withdrawn
• Conditions: Syncope
• Intervention / Treatment: Device: tilt table Erigo®

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).

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• healthy

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tilt table Erigo®; observation of physiological parameters, tilting table with onset of syncope	Device: tilt table Erigo®; tilting table with onset of syncope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical sign of syncope	as diagnosed by the medical staff	1 session of 90 minutes duration

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: University of Zurich

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 27, 2015
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope
• Other Study ID Numbers: ef1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No