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Clinical Trials

As a multisensor wearable, the Cortrium C3 device covers research fields within Heart diseases, Oncology, Neurology and Psychopharmacology. We are proud that our monitoring equipment and the Cortrium app are included in several clinical trials.

So far Cortrium is involved in clinical trial testing in Denmark, Germany, The Netherlands and Austria.

Naestved Hospital (DK) - Pilot study

C3 device – Quality test

Number of Subjects:
32 subjects – Healthy volunteers recruited from the healthcare personnel at Naestved Hospital (8 males and 24 females)

Thesis:
Data validation of pulse and respiratory rate and usability studies via questionnaires

C3 device:
Included as wearables device to acquire data for the pulse and the respiratory rate.

Period:
February-March 2015

Keywords:
Pulse, Respiratory rate, Usability study

Responsible:
University College Zealand

Updated 1. April 2017

  • Pilot study – 32 Healthy volunteers – COMPLETED 100%
Naestved Hospital - Oncology (Cancer)

Clinical Testing of the Cortrium C3 Device for Continuous Measurements of Pulse, Respiratory Rate, Body Surface Temperature and Accelerometer Data for Patients with Cancer

Number of Subjects:
37 cancer patients admitted to the hospital in a febrile condition (temperature of ≥ 38,0°C or more).

Thesis:
Thesis 1) Pulse: The C3 device produces clinically validated pulse data.
Thesis 2) Respiratory rate: The C3 device produces clinically validated respiratory rate data (breaths per minute).
Thesis 3) Infection: With no justified statistical significant correlation between skin and body temperature, the study is exploring how to prevent aggravated or lethal outcomes of cancer treatment, e.g. chemotherapy, by using vital signs measurements combined with accelerometer data to detect infection levels.
Thesis 4) The qualitative study: The study will report the advantages and disadvantages regarding new technological solutions, and the change in workflow and healthcare provision as it is experienced by the healthcare personnel and the patients. The data validation studies (thesis 1-3) will be tested in comparison with golden standard measurements methods and/or data validated medical equipment.

C3 device:
Included as wearables device to acquire data: Pulse, Respiratory rate, Accelerometer & Body Surface Temperature.

Period:
March 2016 – August 2016

Keywords:
Vital Sign Parameters, Pulse, Respiratory rate, Infection, Data validation

Responsible:
Sponsor: Cortrium
Investigator: Naestved Hospital

Updated 1. April 2017

  • Naestved Hospital – 37 patients – COMPLETED 100%
Bispebjerg Hospital - Atrial Fibrillation

C3 device – Data Validation

Number of Subjects:
150 patients who are planned for ambulatory arrhythmia Holter recordings for the detection of the possible occurrence of intermittent (paroxysmal) atrial fibrillation.

Thesis:
1:1 comparison C3 device vs. Holter monitor – The C3 device is expected to detect the occurrence of atrial fibrillation with an accuracy and sensibility at the same level as the current Holter monitor.

C3 device:
Included as wearables device to acquire ECG data.

Period:
March 2016 – April 2017

Keywords:
Holter monitor, Paraxystic Atrial Fibrillation, Data validation

Responsible:
Sponsor: Cortrium
Investigator: Bispebjerg-Frederiksberg Hospital

Updated 1. May 2017

  • Bispebjerg Hospital – 150 patients 95%
UMC Groningen - Depression

Number of Subjects:
50 healthy volunteers (age 18-35 years) monitored with three monitors in various postures and activities. Laboratory sessions are separated by monitoring in a naturalistic setting with the Ithlete and The Cortrium C3 device during two weeks, five times a day, for five minutes.

Keywords:
Cross-instrument Validity, Reproducibility, and Feasibility of Ambulatory Heart Rate (Variability) Monitoring.

Thesis:
Ambulatory heart rate (variability, HR(V)) monitors have enjoyed increased interest recently. However, doubts about their performance suggest that they could put users at risk for unwittingly crossing safe HR thresholds, while also decreasing their usefulness for obtaining valid scientific measurements. We will, therefore, compare HR(V) measurements from two recently released, ambulatory (HR(V)) monitors (Ithlete Finger Sensor, Cortrium C3) to those of the well validated and widely used VU-AMS monitor. Our goal is to test and compare the validity and reproducibility of data obtained with, and feasibility of, these newly developed monitors.

C3 device:
Included as wearables device to acquire ECG and accelerometer data.

Period:
April – August 2017

Responsible:
Sponsor: iLab (www.ilab-psychiatry.com), and the European Research Council (ERC-CoG-2015; No 681466 to M. Wichers), Department of Psychiatry, University Medical Center Groningen, The Netherlands.
Investigators: Kunkels, van Roon, Wichers, Riese, Department of Psychiatry, and Department of Vascular Medicine, University Medical Center Groningen, The Netherlands.

Updated 24. May 2017

  • UMC – Counter Bar 20%

The feedback we have from the researchers are positive. It is the easy application and the comfort for the patients or individuals included that make the C3 device suitable for any trial where seamless and continuous health data is of core value for the research.

The C3 device is ideal for inclusion as ambulatory equipment in clinical trials.

Bispebjerg Hospital - Atrial Fibrillation (LAACS)

Left Atrial Appendage Closure During Open Heart Surgery (LAACS)

Number of Subjects:
67 patients out of 200 patients are offered to be monitored by the C3 device for detection of atrial fibrillation after heart surgery (left atrial appendage closure).

Thesis:
No patients have a previous history of atrial fibrillation, and all patients who are discharged in sinus rhythm, will be offered to be monitored of the heart rhythm with Holter monitor or the C3 device for one week. The monitoring will investigate weather restoring sinus rhythm is permanent, or if it is the occurrence of the debut of atrial fibrillation.

C3 device:
The ability of the C3 device to detect atrial fibrillation.

Period:
Sept. 2015 – February 2017

Keywords:
Atrial Fibrillation, Holter monitor, Arrhythmias, Heart Diseases, Data validation

Responsible:
Sponsor: Bispebjerg-Frederiksberg Hospital
Investigator: University of Copenhagen

Updated 1. April 2017

  • Bispebjerg Hospital – 67 patients – COMPLETED 100%
UKSH (Kiel & Lübeck) - Oncology (Cancer)

Clinical Testing of the Cortrium C3 Device for Continuous Measurements of Pulse, Respiratory Rate, Body Surface Temperature and Accelerometer Data for Patients with Cancer

Number of Subjects:
25 cancer patients admitted to the hospital for cancer treatment.

Thesis:
Thesis 1) Pulse: The C3 device produces clinically validated pulse data.
Thesis 2) Respiratory rate: The C3 device produces clinically validated respiratory rate data (breaths per minute).
Thesis 3) Infection: With no justified statistical significant correlation between skin and body temperature, the study is exploring how to prevent aggravated or lethal outcomes of cancer treatment, e.g. chemotherapy, by using vital signs measurements combined with accelerometer data to detect infection levels.
Thesis 4) The qualitative study: The study will report the advantages and disadvantages regarding new technological solutions, and the change in workflow and healthcare provision as it is experienced by the healthcare personnel and the patients. The data validation studies (thesis 1-3) will be tested in comparison with golden standard measurements methods and/or data validated medical equipment.

C3 device:
Included as wearables device to acquire data: Pulse, Respiratory rate, Accelerometer & Body Surface Temperature.

Period:
May 2017 – July 2017

Keywords:
Vital Sign Parameters, Pulse, Respiratory rate, Infection, Data validation

Responsible:
Sponsor: Cortrium
Investigator: Universitätsklinikum Schleswig-Holstein

Updated 24. May 2017

  • UKSH – 25 patients 25%
Johannes Kepler University - Dementia

SENEX (SEnsor Networks for EXploring Dementia)

Number of Subjects:
80 subjects (4×20 subjects suffering from Alzheimer Dementia, Mild cognitive impaired, Epilepsy, healthy volunteers (control group))

Thesis:
Prediction of episodes of confusion in dementia

C3 device:
Included as wearables device to acquire data for HRV and accelerometer.

Period:
April-Sept. 2017.

Keywords:
Attention Estimation, Gesture Recognition, Biosignal Analysis, Sensor Networks, Computer-aided Diagnosis, Pattern Recognition, Dementia, Epilepsy, Alzheimer

Responsible:
Johannes Kepler University (Department of Business Informatics & Department of Neurology)

Updated 1. May 2017

  • Johannes Kepler University – 80 patients 10%
Aarhus University Hospital - COPD

Feasibility and effect of telerehabilitation program for COPD patients vs standard follow-up

Number of Subjects:
40 patients who are planned for participating in a rehabilitation program for Chronic Obstructive Lung Disease (COPD).

Thesis:
To assess and compare the feasibility and effect of a telerehabilitation program with a new and innovative interactive platform compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with COPD.

C3 device:
Included as wearables device to acquire data: Pulse and Respiratory rate.

Period:
February 2017 – July 2017

Keywords:
COPD, Data validation

Responsible:
Sponsor: Physiord
Investigator: Aarhus University Hospital

The clinical trial is supported by the Eurostar II program:

Updated 1. April 2017

  • AUH – 40 patients 20%