Usability study consent #3

Principal Investigator: MITRAL

Introduction

You are participating in a formative usability study aimed at evaluating the Apneal software, a medical device designed for the screening of sleep-related breathing disorders. This study is conducted by Mitral with the goal of improving the user experience of this software.

Study Objective

The primary objective of this study is to collect feedback and opinions from participants regarding the installation and registration process within the Apneal application, the usability of the generated sleep report, the identification of essential data, and the overall user experience in a clinical practice setting. Your participation will help enhance the design and functionality of the application for future use by both patients and healthcare professionals.

Procedure

If you agree to participate in this study, you will be asked to complete the usability questionnaire that has been sent to you.

Confidentiality and Data Security

All information collected during this study will remain confidential and anonymous. Your identity will not be disclosed in any reports or publications resulting from this study. Data will be securely stored in compliance with GDPR regulations.

Risks and Benefits

There are no significant risks associated with your participation in this study. Your participation provides an opportunity to contribute to the future development of Apneal by improving its usability and effectiveness for medical use.

Participant Rights

Your participation in this study is voluntary. You have the right to withdraw your consent at any time without penalty. You are also free to ask any questions regarding the study before deciding whether to participate.

Consent

I confirm that I have read and understood the information above regarding the usability study on Apneal. I voluntarily consent to participate in this study and understand that I may withdraw my consent at any time without prejudice. I also consent to the use of the data collected during this study for research purposes, subject to confidentiality and data protection.

For any questions regarding this study, please contact Thoma Bigueres, the study coordinator, by email at thoma.bigueres@apneal.ai.