Early Detection of Clinical Deterioration Using an Integrated Remote Monitoring System in Lung Cancer Patients Receiving Cytotoxic Chemotherapy.
Phase: NA
Conditions: Non-small Cell Lung Cancer, Remote Monitoring, Mobile Health, Chemotherapy Effect
Sponsor: Ziekenhuis Oost-Limburg

 
 
 
Document identification 
Version No: v1  
Version Date:06DEC2023 
 
Page 1 of 37 
TEMP –101, Version 1.0 
Effective date: 19JUN2023 
 
 
 
 
 
 
 
 
 
ETERNALS 
Early detection of clinical deterioration using an integrated remote monitoring 
system in lung cancer patients receiving cytotoxic chemotherapy. 
 
 
 
Protocol 
Version number: version 2 
Version date: 6th of March 2024 
 
 
 
 
 
 
 
 
STUDY REFERENCE NUMBERS 
Clinical trials.gov: XXXClinicalTrails.govNumber 
SPONSOR: 
Ziekenhuis Oost-Limburg 
Study reference 
number 
Z2023080 
EudraCT: 
B3712024000013 
 

 
 
1. DOCUMENT HISTORY 
Version no 
Version 
date 
Author 
Reason for change 
06DEC2023 
V1 
Julie Vranken 
Initial draft of the study protocol 
06MAR2024 
V2 
Julie Vranken 
Adjustment based on the comments of the 
Ethical Committee 
 
 
 
 
 
 
 

 
 
2. PROTOCOL SIGNATURE PAGE 
I agree to conduct this study in accordance with the design and specific provisions of this protocol. 
I understand that I may terminate or suspend enrolment of the study at any time if it becomes 
necessary to protect the best interests of the study subjects. 
I agree to personally conduct or supervise this study and to ensure that all associates, colleagues, and 
employees assisting in the conduct of this study are informed about their obligations in meeting these 
commitments. 
I will conduct the study in accordance with the protocol, Good Clinical Practice, the Declaration of 
Helsinki, and the moral, ethical and scientific principles that justify medical research. The study will be 
conducted in accordance with all relevant laws and regulations relating to clinical experimentation and 
the protection of patients. 
I will ensure that the requirements relating to Ethics Committee review and approval are met. 
I agree to maintain adequate and accurate records and to make those records available for audit and 
inspection in accordance with relevant regulatory requirements including the provision of direct access 
to data and source documents. 
I agree to promptly report to the Ethics Committee any changes in the research activity and all 
unanticipated problems involving risks to human subjects or others. Additionally, I will not make any 
changes in the research without Ethics Committee approval, except where necessary to ensure the 
safety of study participants. 
 
Name of the  
Principal Investigator  
Site name 
Signature 
Date 
Dr. Maarten Criel 
Ziekenhuis Oost-Limburg 
 
 
 
 
 
 

 
 
3. PROTOCOL SUMMARY 
Full title 
Early detection of clinical deterioration using an integrated remote monitoring 
system in lung cancer patients receiving cytotoxic chemotherapy. 
Protocol number 
Z-2023080 
Short title/acronym 
ETERNALS  
Study duration 
16 months  
Rationale 
Lung cancer is a highly prevalent malignant tumour with 5.563 new cases in Belgium 
in 2020. Up to 70% of patients present with locally advanced or metastatic disease 
at diagnosis. Most of these patients require systemic therapy including cytotoxic 
chemotherapy as part of their treatment plan. The mortality rate in this patient 
population remains high due to the aggressive nature of the disease, but also due 
to treatment related toxicities such as dehydration, infection, and anaemia, 
resulting in emergency department (ED) visits and rehospitalizations. Routine 
administration of highly effective anti-emetics and the use of granulocyte colony-
stimulating growth factors greatly reduced the complication rate in these patients. 
Also, remote symptom monitoring using a web-based tool to which patients can 
self-report their toxicities (i.e., patient-reported outcomes; PROs) had a marked 
impact on reducing ED visits and increasing overall survival in the PRO group. 
Despite these successes there is still a large proportion of lung cancer patients for 
whom weekly self-reports are not feasible. More specific: low socio-economic 
status, elderly patients and social isolation are associated with low compliance. The 
latter lung cancer patient subgroup is at the highest risk of under-detection when 
presenting with treatment- or disease-related toxicity. We hypothesize that 
implementation of an integrated remote monitoring system tracking heart rate, 
heart rate variability, body temperature, respiration rate, nocturnal oxygen 
saturation, sleep tracking and daily activity level via an unobtrusive wearable device 
is more performant and less burdensome compared to other self-reporting methods 
(e.g., PROs). The primary aim of this project is to set up and implement an integrated 
remote monitoring system in the routine care of lung cancer patients receiving 
cytotoxic chemotherapy, in which the remote monitoring is enabled via an 
unobtrusive wearable device. Via this innovative implementation we believe that 
patient care can be drastically improved due to the earlier detection of deterioration 
(i.e., less rehospitalizations and ED visits), especially for those high-risk frail 
patients. 
Objectives 
The primary objective of this project is to determine the feasibility of an integrated 
remote monitoring system in the routine care of lung cancer patients receiving 
cytotoxic chemotherapy. 
Study design 
Monocentre prospective interventional feasibility study 
Study population 
Stage IV lung cancer patients treated with cytotoxic chemotherapy, older than 18 
years of age. 
Main study 
endpoints 
• 
Determining the time interval between clinical deterioration detected by 
the integrated remote monitoring system and the first contact with the 
care team (i.e., in current clinical practice the patient suffering from 
chemotherapy-associated symptoms self-reports at the ED) 
• 
Patient compliance in using the integrated remote monitoring system 
Chief investigator/ 
project leader 
Dr. Maarten Criel 

 
 
Sponsor  
 
Ziekenhuis Oost-Limburg A.V.  
Synaps Park 1 
3600 Genk - BELGIUM 
 
 
 

 
 
4. TABLE OF CONTENTS 
1. 
DOCUMENT HISTORY ...................................................................................................................... 2 
2. 
PROTOCOL SIGNATURE PAGE ......................................................................................................... 3 
3. 
PROTOCOL SUMMARY .................................................................................................................... 4 
4. 
TABLE OF CONTENTS ...................................................................................................................... 6 
5. 
LIST OF ABBREVIATIONS ................................................................................................................. 8 
6. 
BACKGROUND AND RATIONALE ..................................................................................................... 9 
7. 
OBJECTIVES AND OUTCOME MEASURES ........................................................................................ 9 
7.1 
Primary Objective ................................................................................................................... 9 
7.2 
Secondary Objectives .............................................................................................................. 9 
7.3 
Endpoints .............................................................................................................................. 10 
8. 
STUDY DESIGN .............................................................................................................................. 11 
8.1 
Retrospective sub-study: Phenotyping the Stage IV lung cancer patients ........................... 11 
8.2 
Prospective single-arm monocenter interventional feasibility study: .................................. 12 
8.2.1 
Wearable device – Oura ring ........................................................................................ 13 
8.2.1.1 
GDPR compliance of Oura ring servers ......................................................................... 13 
9. 
STUDY POPULATION ..................................................................................................................... 14 
9.1 
Inclusion criteria ................................................................................................................... 14 
9.2 
Exclusion criteria ................................................................................................................... 14 
9.3 
Subject withdrawal ............................................................................................................... 14 
10. 
STUDY INTERVENTION ............................................................................................................. 15 
10.1 
Description of the study intervention ................................................................................... 15 
11. 
STUDY PROCEDURES AND ASSESSMENTS ................................................................................ 15 
11.1 
Schedule of events ................................................................................................................ 16 
11.2 
Screening period ................................................................................................................... 16 
11.3 
Intervention .......................................................................................................................... 16 
11.4 
Follow-up period ................................................................................................................... 17 
11.5 
End of study visit ................................................................................................................... 17 
11.6 
Study procedures .................................................................................................................. 17 
11.6.1 
Informed consent .......................................................................................................... 17 
11.6.2 
Study specific information that will be collected .......................................................... 17 
11.6.3 
Questionnaires .............................................................................................................. 18 
12. 
SAFETY REPORTING .................................................................................................................. 20 
12.1 
Definitions ............................................................................................................................. 20 
12.2 
Collection and reporting of Adverse Events ......................................................................... 22 
13. 
RISK BENEFIT ANALYSIS ............................................................................................................ 22 
14. 
STATISCIAL ANALYSIS ............................................................................................................... 23 

 
 
14.1 
Statistical hypothesis ............................................................................................................ 23 
14.2 
Sample size calculation ......................................................................................................... 23 
14.3 
Statistical analysis plan ......................................................................................................... 23 
15. 
ETHICAL CONSIDERATIONS ...................................................................................................... 24 
15.1 
Ethics Committee review and reports .................................................................................. 24 
15.2 
Amendments ........................................................................................................................ 24 
15.3 
General Data Protection Regulation ..................................................................................... 24 
16. 
DATA MANAGEMENT .............................................................................................................. 24 
16.1 
Data collection tools ............................................................................................................. 24 
16.2 
Data handling ........................................................................................................................ 25 
16.3 
Data storage .......................................................................................................................... 25 
17. 
MONITORING, AUDIT AND INSPECTION .................................................................................. 25 
17.1 
Monitoring ............................................................................................................................ 25 
17.2 
Audit and inspection ............................................................................................................. 26 
18. 
PUBLICATION AND DATA SHARING POLICY ............................................................................. 26 
19. 
INSURANCE .............................................................................................................................. 26 
20. 
REFERENCES ............................................................................................................................. 27 
21. 
Appendix .................................................................................................................................. 28 
21.1 
Declaration of conformity Oura Ring and charger ................................................................ 28 
21.2 
Screening log ......................................................................................................................... 34 
 
 
 

 
 
5. LIST OF ABBREVIATIONS 
The following table presents the abbreviations and acronyms used in this document. 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
AR 
Adverse Reaction 
eCRF 
Electronic Case Report Form 
EC 
Ethics Committee  
ED 
Emergency Department 
EMR 
Electronic Medical Record 
EOS 
End Of Study 
GDPR 
General Data Protection Regulation 
HRV 
Heart rate variability 
MAUQ 
mHealth Usability questionnaire 
ICF 
Informed Consent Form 
MDR 
Medical Device Regulation 
PI 
Principal Investigator 
PROs 
Patient reported outcomes 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SAR 
Serious Adverse Reaction 
SUS 
System Usability questionnaire 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 

 
 
6. BACKGROUND AND RATIONALE 
Lung cancer is a highly prevalent malignant tumor with 5.563 new cases in Belgium in 20201. Up to 70% 
of patients present with locally advanced or metastatic disease at diagnosis 1. Most of these patients 
require systemic therapy including cytotoxic chemotherapy as part of their treatment plan. The 
mortality rate in this patient population remains high due to the aggressive nature of the disease, but 
also due to treatment related toxicities such as dehydration, infection, and anemia, resulting in 
emergency department (ED) visits and rehospitalizations. Routine administration of highly effective 
anti-emetics and the use of granulocyte colony-stimulating growth factors greatly reduced the 
complication rate in these patients 2, 3. Also, remote symptom monitoring using a web-based tool to 
which patients can self-report their toxicities (i.e., patient-reported outcomes; PROs) had a marked 
impact on reducing ED visits and increasing overall survival in the PRO group 4-6. Despite these 
successes there is still a large proportion of lung cancer patients for whom weekly self-reports are not 
feasible. More specific: low socio-economic status, elderly patients and social isolation are associated 
with low compliance 7, 8. The latter lung cancer patient subgroup is at the highest risk of under-
detection when presenting with treatment- or disease-related toxicity. We hypothesize that 
implementation of an integrated remote monitoring system tracking heart rate, heart rate variability, 
body temperature, respiration rate, nocturnal oxygen saturation, sleep tracking and daily activity level 
via an unobtrusive wearable device is more performant and less burdensome compared to other self-
reporting methods (e.g., PROs). The primary aim of this project is to set up and implement an 
integrated remote monitoring system in the routine care of lung cancer patients receiving cytotoxic 
chemotherapy, in which the remote monitoring is enabled via an unobtrusive wearable device. Via this 
innovative implementation we believe that patient care can be drastically improved due to the earlier 
detection of deterioration (i.e., less rehospitalizations and ED visits), especially for those high-risk frail 
patients. 
 
7. OBJECTIVES AND OUTCOME MEASURES 
The primary objective of this project is to determine the feasibility of an integrated remote monitoring 
system in the routine care of lung cancer patients receiving cytotoxic chemotherapy. 
7.1 
Primary Objective 
• 
Determining the time interval between clinical deterioration detected by the integrated 
remote monitoring system and the first contact with the care team (i.e., in current clinical 
practice the patient suffering from chemotherapy-associated symptoms self-reports at the ED) 
• 
Patient compliance in using the integrated remote monitoring system 
 
7.2 
Secondary Objectives 
• 
Acceptability and usability of the integrated remote monitoring system by both the patient 
and the healthcare specialists 
• 
Determine the number of ED visits retrospectively, including the disease- and therapy 
related/induced complications (retrospective sub-study, see Paragraph 8 STUDY DESIGN). 
 
 
 

 
 
7.3 
Endpoints 
Primary objective 
• 
Number of days prior to the ED visit the remote monitoring system detects changes in vital 
parameters (time interval expressed in days, description of the changes in trends of the vital 
parameters, theoretical impact of the remote monitoring system on early intervention 
expressed in days) 
• 
Compliance rate to the remote monitoring system (expressed in %) 
Secondary objective 
• 
Acceptability and usability (expressed in %) 
• 
Retrospective sub-study has the following endpoints: (see Paragraph 8 STUDY DESIGN) 
o Demographical phenotyping of Stage IV lung cancer patients (age, gender, 
comorbidities, smoking status/history, caregiver support, etc.) 
o Number of disease-related and therapy-induced complications  
o Tumor-specific/related information (metastasis, blood analyses, imaging, pulmonary 
functioning testings, etc.) 
o Treatment-related information (type of treatment and medication, time-to-treatment 
from diagnosis, number of hospitalizations, number of presentations to the ED 
department) 
o Outcomes and mortality (3, 6 and 12 months) 
 
 

 
 
8. STUDY DESIGN 
The ETERNALS project consists of two parts, a retrospective sub-study and the main, monocenter, 
prospective, single-arm interventional study (Figure 1).  
 
Figure 1. Overview of the presented studies within the ETERNALS project. 
8.1 
Retrospective sub-study: Phenotyping the Stage IV lung cancer patients 
From Jan 2018-Dec 2023 data will be collected from the electronic medical record of Ziekenhuis Oost-
Limburg, with the main objective to identify and phenotype patients diagnosed with Stage IV lung 
cancer. Conclusions and findings from this data will be compared to the prospective study, e.g., the 
number of ED visits to estimate a possible (theoretical) impact of the remote monitoring system on 
the time-to-ED-visit. In addition, this can also be incorporated in the estimation of the remote 
monitoring reduced complication rate and mortality. Moreover, this data is also important for the 
insights of the compliance rates in the prospective trial (e.g., number of comorbidities, age, the 
presence of an informal caregiver, severity of disease, etc.). The specific endpoints are described in 
Paragraph 7.3 Endpoints.  
Data that will be collected during this retrospective study consists of, but is not limited to:  
• 
Age 
• 
Gender 
• 
Smoking status and history 
• 
Imaging results (PET, CT, etc.)  
• 
Current and previous treatment in relation to the cancer diagnosis 
• 
Mortality 
• 
Time in between diagnosis, treatment and death/recovery 
• 
Number of ED visits, and associated complications, treatment and hospital duration 
• 
Number of rehospitalizations 
• 
Medication profile 
• 
Comorbidities (diabetes, heart failure, hypertension, etc.) 
• 
Treatment-induced complications, toxicity 
• 
Family history of cancer 
• 
Tumor-specific information (metastasis, etiology, etc.) 
 
 

 
 
8.2 
Prospective single-arm monocenter interventional feasibility study:  
This is a single-arm, unblinded, interventional feasibility study in which the integrated remote 
monitoring system using a wearable device will serve to follow-up lung cancer patients receiving 
cytotoxic chemotherapy. Patients will be included after receiving the diagnosis of lung cancer with 
indication to treat with cytotoxic chemotherapy. After signing the informed consent patients receive 
the wearable device to monitor their vital parameters at home, awaiting their first round of chemo 
(baseline). Next, patients will keep wearing the wearable device daily, which enables the remote 
monitoring with the care team until they have finalized their entire chemotherapy cycle (4 rounds, in 
which each round is followed by 3 weeks of recuperation). This implies the total project duration per 
patient corresponds to 15 weeks of remote monitoring (Figure 2).  
 
Figure 2. Overview of the ETERNALS prospective single-arm study timeline. 
 
 

 
 
8.2.1 
Wearable device – Oura ring 
The wearable device patients receive is an Oura ring (Figure 3), which has the capacity to measure vital 
signs in a very unobtrusive manner. The vital signs that will be measured are: heart rate, heart rate 
variability (HRV), oxygen saturation, level of activity, sleep (incl sleep stages), sleep quality, early illness 
detection (shifts in temperature and HRV), temperature and stress (based on temperature, HRV and 
sleep).  
 
Figure 3. The Oura ring, which consists of several sensors to measure vital signs. The Oura ring is sized to the desired finger.  
The choice for this wearable is based on its unobtrusiveness, its wide range of parameters it can 
measure and the battery life, which lasts up to 7 days. The ring can be worn on the finger of choice, of 
which the size is determined via the sizing kit. The Oura ring is a fitness device (CE marked, see 
Appendix ‘Declaration of conformity Oura Ring and charger’), and is not classified as a medical device, 
nor will it be used in safety or performance testing, and therefore, it does not fall under the 
classification of the medical device regulation (MDR).  
8.2.1.1 GDPR compliance of Oura ring servers 
Oura uses technical and organizational safeguards to keep the data safe and secure. Where 
appropriate, these safeguards include measures such as anonymization or pseudonymization of 
personal data, strict access control, and the use of encryption to protect the data they process. They 
also ensure their staff receives adequate training to guarantee personal data is processed only in 
accordance with their internal policies, consistent with their obligations under applicable law, i.e., 
GDPR. Oura does not sell or rent the patient’s personal information and only shares the personal data 
with certain trusted service providers after consent. They also require these service providers to 
protect the personal information to at least the same standards that they do.  
Oura upholds the security measures by routinely testing their services, systems, and other assets for 
possible security vulnerabilities. They update the Oura App and the ring firmware regularly. They 
recommend to always having the latest app and firmware versions installed to maximize the protection 
of your data. Oura’s data privacy practices are maintained in compliance with the California Consumer 
Privacy Act of 2018 (CCPA) and the General Data Protection Regulation (GDPR). 
Data is transferred once every 24 hours to the server automatically. The patients connect the Oura ring 
to the Oura App via Bluetooth on their smartphone. For this study, data will be pseudonymized, 
meaning a study email and ID will be used to generate an account for the patient. Therefore, the data 
is also already pseudonomized on the Oura servers.  
Oura stores personal data primarily within the geographic region where it is collected (EU server 
based).  
 
 

 
 
9. STUDY POPULATION 
The study population will only be described for the prospective feasibility study.  
The study will enroll a total of 50 subjects over a period of 12 months. They will be recruited in 1 center 
located in Belgium, Ziekenhuis Oost-Limburg. Patients that receive the diagnosis of Stage IV lung 
cancer, are proposed therapy via cytotoxic chemotherapy and are compliant to the inclusion criteria 
are eligible to participate to the study. Eligible patients will be screened by the principal investigator 
(PI), after which they will receive information concerning the study. All screened patients will be 
entered into the Screening Log. The patients will receive enough time to review the informed consent 
and provided information and they will have time to ask questions to the PI (in accordance with the 
Declaration of Helsinki and GDPR). After signing the informed consent, the patient will be enrolled in 
the study as described in the paragraph ‘STUDY PROCEDURES AND ASSESSMENTS’.  
 
9.1 
Inclusion criteria 
In order to be eligible to participate in this study, a subject must meet all of the following criteria; 
Provide signed and dated informed consent 
Inclusion criteria:  
- 
Patient must be in the possession of a smartphone  
- 
Diagnosis of Stage IV lung cancer patients treated with cytotoxic chemotherapy 
- 
Older than 18 years of age 
An inherent consequence of remote monitoring is the exclusion of patients that not have a 
smartphone. However, recent literature suggests that 92% of the Belgian population has access to a 
smartphone 9.  
9.2 
Exclusion criteria 
A potential subject who meets any of the following criteria will be excluded from participation in this 
study: 
- 
Life expectancy of less than 6 weeks 
- 
Not able to understand the Dutch language 
 
9.3 
Subject withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care. They may also be 
discontinued from the study at the discretion of the Investigator. The Investigator may also withdraw 
subjects who violate the study plan, or to protect the subject for reasons of safety or for administrative 
reasons. It will be documented whether or not each subject completes the clinical study.  

 
 
10. STUDY INTERVENTION 
10.1 Description of the study intervention 
Eligible patients are screened (i.e., Stage IV lung cancer and being treated with cytotoxic 
chemotherapy) and provided with the necessary information. No randomization is done, as this is a 
single-arm study design. Patients are approached in-hospital during their routine visits and 
consultations with their treating physicians. Patients can also be approached when hospitalized (only 
when they have not initiated their chemotherapy yet). In other words, patients do not need to plan an 
additional, unplanned visit to the hospital to be enrolled. After signing the informed consent and prior 
to the patients’ first round of cytotoxic chemotherapy they will be equipped with the Oura ring.  
First, the patient will be asked to test the sizing kit and communicate his/her finger of preference to 
wear the Oura ring. The sizing kit will help to identify the ring size that suits best to the diameter of the 
preferred finger of the patient, and that guarantees the best contact to the finger to have the best 
measuring capabilities. Once the size is determined, the patient will receive the Oura ring (i.e., the 
sizing kits offers a variety of sizes, of which we have all rings directly available). The patient is asked to 
wear the ring on the same finger during the entire study and to only take the ring off when charging. 
In other words, the patient is asked to wear the ring throughout the entire day. The study team will 
provide the patient with an e-mail address (e.g., eternals001@mobilehealthunit.org) that will be used 
to create an account on Oura Web and app. At the site the deidentifying key will be kept in a secure 
folder in ‘Teams’. The patient will be asked to download the Oura App on his/her smartphone. Next, 
the study team will help the patient in logging into the Oura App and Web and connecting the Oura 
ring with Bluetooth to the patient’s smartphone. Once all the connections are set in place, the patient 
starts wearing the Oura ring and the study starts. The data will be checked twice a week, to check for 
compliance or to identify possible technical issues. Patients will be made attentive that when they 
experience any distress, clinical deterioration, etc. they need to present themselves to the ED. The 
patient will be made attentive this remote monitoring system is not an alarm system/ being reviewed 
24/7, nor that any interventions based on the study data will be made. The patient will wear the Oura 
ring for approximately 15 weeks, after which he/she will return the ring to the hospitals in accordance 
with a routine visit. After the first and third round of chemotherapy, and at the end of the study a 
questionnaire will be asked to the patient (i.e., mHealth Usability questionnaire, MAUQ).  
In addition, the healthcare practitioners (i.e., treating physician and nurse) will be asked to fill in the 
System Usability questionnaire (SUS) once after using the Oura Web platform to review the data. This 
will be done after a training session that will be provided by the study team. Important to note is that 
the nurse/treating physician will not act upon the study data and the standard-of-care is applied.  
11. STUDY PROCEDURES AND ASSESSMENTS 
No additional visits or procedures are required when for the patient when participating to the study. 
Once the informed consent is signed, data from the electronic medical record (EMR) will be recorded 
and updated if/when changed during the study*:  
- 
Demographic data (age, gender, comorbidities, relevant medical history, smoking 
status/history) 
- 
Imaging results* (PET, CT, etc.)  
- 
Current and previous treatment in relation to the cancer diagnosis 
- 
Mortality* 
- 
Time in between diagnosis, treatment and death/recovery* 
- 
Number of ED visits, and associated complications, treatment and hospital duration* 
- 
Number of rehospitalizations* 
- 
Medication profile* 

 
 
- 
Comorbidities (diabetes, heart failure, hypertension, etc.) 
- 
Treatment-induced complications, toxicity* 
- 
Family history of cancer 
- 
Tumor-specific information (metastasis, etiology, etc.)* 
11.1 Schedule of events 
The hereafter schedule of events only apply to the prospective feasibility study. 
Table 1. Overview of the schedule of events. The study intervention does not include additional procedures, the data will be 
checked twice a week. Abbreviations: EMR, electronic medical record; AE, adverse events. 
Visit 
Screening Baseline/inclusion 
1 
2 
3 
4 
EOS 
Study days 
 
Day 0 
Day 
30 
Day 
51 
Day 
72 
Day 
93 
Day 
114 
Window 
 
7 days 
7 
days 
7 
days 
7 
days 
7 
days 
7 
days 
Informed consent 
 
X 
 
 
 
 
 
Review 
inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
Demographics/medical 
history/etc. (see prior 
section), 
hereafter 
referred 
to 
as 
EMR 
information 
 
X 
 
 
 
 
 
Standard-of-care 
performed 
procedure 
and examinations 
 
X 
X 
X 
X 
X 
X 
Study intervention 
 
X 
X 
X 
X 
X 
X 
EMR information 
updated 
 
 
 
X 
X 
 
X 
AE Evaluation 
 
X 
 
X 
X 
 
X 
Questionnaires 
 
 
X 
 
X 
 
X 
11.2 Screening period 
As mentioned in paragraph ‘STUDY INTERVENTION’ patients that are eligible will be screened, only if 
they comply to the inclusion criteria. Screening will be done using the Screening log (Appendix 
Screening log). Screening will be done after diagnosis of Stage IV lung cancer. Screening will be done 
by the PI, after which he communicates his findings to the study team. 
 
11.3 Intervention 
Upon inclusion and signing the informed consent the following steps will be taken (as described in the 
paragraph ‘Description of the study intervention’): 
- 
Determining the ring size 
- 
Setting up the pseudonymized account (e.g., eternals001@mobilehealthunit.org) 
- 
Setting up the technical steps (account, Bluetooth, etc.)  

 
 
- 
Providing education on using and charging the ring 
- 
Repeating the study protocol  
11.4 Follow-up period 
Before the first round of cytotoxic chemotherapy the patient is equipped with the Oura ring. Next, the 
patient is expected to wear the ring the next 15 weeks, up to a maximum of 3 weeks after his/her last 
round of chemotherapy. Approximately 18-22 weeks of remote monitoring is expected per patient 
(dependent on the time between inclusion and initiation of cytotoxic chemotherapy).  
 
11.5 End of study visit 
During a routine care visit the patient is asked to take the Oura ring with him/her to the hospital. The 
patient can leave the Oura ring at the designated boxes that will be foreseen at the departments.   
 
11.6 Study procedures 
11.6.1 Informed consent 
All subjects, or their legally authorized representative(s), must sign and date the informed 
consent document that has been approved by the appropriate EC before any study-specific 
procedures are performed. If new information becomes available that may be relevant to the 
participant’s willingness to continue participation in the study, this will be communicated to 
him/her in a timely manner. Such information will be provided via a revised ICF or an addendum 
to the original ICF.  
The PI or his/her representative is responsible for explaining the nature of the study to the 
subject and answering all questions regarding the study. Moreover, the PI or his/her 
representative is responsible for ensuring that the participant fully understands the nature and 
purpose of the study. No subject should be obliged to participate in the study. The subject must 
understand that refusal to participate in the study or withdrawal from the study at any stage is 
without any prejudice to the subject’s subsequent care. The subject must be allowed sufficient 
time to decide whether they wish to participate. The subject must be made aware of and give 
consent to direct access to his/her source medical records by study monitors, auditors, the EC, 
and regulatory authorities. The subject should be informed that such access will not violate 
participant confidentiality or any applicable regulations. The subject should also be informed 
that he/she is authorizing such access by signing the ICF.  
After signing the informed consent, the original signed informed consent is retained by the site 
and a copy of the informed consent is provided to the subject. 
The process of obtaining informed consent should be documented in the patient’s source 
documents. 
 
11.6.2 Study specific information that will be collected 
The following information will be collected at the start and during the study:  
- 
Demographic data (age, gender, comorbidities, relevant medical history, smoking 
status/history) 
- 
Imaging results* (PET, CT, etc.)  
- 
Current and previous treatment in relation to the cancer diagnosis 
- 
Mortality* 
- 
Time in between diagnosis, treatment and death/recovery* 

 
 
- 
Number of ED visits, and associated complications, treatment and hospital duration* 
- 
Number of rehospitalizations* 
- 
Medication profile* 
- 
Comorbidities (diabetes, heart failure, hypertension, etc.) 
- 
Treatment-induced complications, toxicity* 
- 
Family history of cancer 
- 
Tumor-specific information (metastasis, etiology, etc.)* 
 
11.6.3 Questionnaires 
All questionnaires used within this protocol are validated. Patients will be asked to fill in the MAUQ 
questionnaire (Figure 4) after the first and third round of chemotherapy and at the end of the study 
(i.e., when they return the Oura ring during a routine visit). The questionnaire will be translated to 
Dutch.  

 
 
 
Figure 4. mHealth Usability questionnaire is a validated questionnaire that will be used to assess the use of the Oura ring and 
app by the patient.   
The healthcare practitioners (i.e., nurse and one treating physician) will be asked to fill in the SUS 
questionnaire after they received a training session from the study team. The questionnaire will also 
be translated to Dutch.  

 
 
 
Figure 5. The system usability Scale questionnaire will be used to assess the potential of the Oura ring and its associated 
platform by the healthcare practitioners.  
 
12. SAFETY REPORTING 
12.1 Definitions 

 
 
An Adverse Event (AE) is any untoward medical occurrence in a subject during the study, related to 
the Oura ring. 
 
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: 
- 
Results in death (note that death is an outcome of an event; the event(s) causing death should be 
recorded); or 
- 
Is life-threatening; or 
- 
Requires inpatient hospitalization or prolongation of existing hospitalization; or 
- 
Results in persistent or significant disability/incapacity; or 
- 
Requires medical or surgical intervention to prevent life threatening illness; or 
- 
Results in a congenital anomaly/birth defect 
 
Note that a planned hospitalization for pre-existing condition, or a procedure required by the protocol, 
without a serious deterioration in health, is not considered a serious adverse event. 
 
A Device Deficiency (DD) is any inadequacy of an investigational device related to its identity, quality, 
durability, reliability, safety or performance. This may include malfunctions, use error, or inadequacy 
in the information supplied by the manufacturer. 
 
An Adverse Device Effect (ADE) is any adverse event related to the use of an investigational device. 
This includes any AE resulting from insufficiencies or inadequacies in the instructions for use, the 
deployment, the implantation, the installation, the operation, or any malfunction of the investigational 
medical device. This includes as well any event that is a result of a use error or intentional abnormal 
use of the investigational medical device. 
 
A Serious Adverse Device Effect (SADE) is any ADE that: 
- 
Results in death (note that death is an outcome of an event; the event(s) causing death should be 
recorded); or 
- 
Is life-threatening (at the time of the event); or 
- 
Requires inpatient hospitalization or prolongation of existing hospitalization; or 
- 
Results in persistent or significant disability/incapacity; or 
- 
Requires medical or surgical intervention to prevent life threatening illness; or 
- 
Results in a congenital anomaly/birth defect 
 
An Unanticipated Serious Adverse Device Effect (USADE) is a SADE which by its nature, incidence, 
severity or outcome has not been identified in the current version of the risk analysis report. 
The severity of an event refers to the extent to which it affects the participant’s daily activities. This 
severity will be judged by the investigator based on his/her discretion and the definitions of severity 
as follows: 
- 
Mild: The event doesn’t affect the participant’s daily activities. 

 
 
- 
Moderate: The event interferes with the participant’s daily activities and may or may not require 
medical intervention. 
- 
Severe: The event prevents the participant to perform his/her daily activities and requires 
therapeutic intervention. 
 
The relationship to study intervention or study participation must be assessed and documented for all 
adverse events. Evaluation of relatedness must consider etiologies such as natural history of the 
underlying disease, concurrent illness, concomitant therapy, study-related procedures, accidents, and 
other external factors. The following guidelines are used to assess relationship of an event to study 
intervention: 
- 
Related (Possible, Probable, Definite) 
o 
The event is known to occur with the study intervention. 
o 
There is a temporal relationship between the intervention and event onset. 
o 
The event abates when the intervention is discontinued. 
o 
The event reappears upon a re-challenge with the intervention. 
- 
Not Related (Unlikely, Not Related) 
o There is no temporal relationship between the intervention and event onset. 
o An alternate etiology has been established. 
 
12.2 Collection and reporting of Adverse Events 
All subjects will be monitored for AEs during the study. All AEs will be recorded by the investigator 
from the time the subject signs informed consent until the end of study visit. Any significant finding 
that was present prior to administration of the study intervention will be considered as medical history.  
All AEs and SAEs reported spontaneously by the subject or observed by the investigator or his/her staff 
will be recorded in the medical file of the patient. They will be reported to the sponsor without undue 
delay by entering them in the eCRF.  
The investigator will report all SAEs within 24 hours of notice to the sponsor and, if requested by 
national law or regulation, to the appropriate EC.  
The sponsor will report the fatal and life-threatening related SAEs to the EC upon the requirements of 
the EC. 
 
13. RISK BENEFIT ANALYSIS 
The risk benefit analysis will only be described for the prospective feasibility study.  
Risks 
No major risks are associated to participate to the study, as no interventions based on the study will 
be done and standard-of-care is still applied. The following possible risks are associated to the study;  
- 
Patients will be able to see their data, which might cause concerns regarding their health. 
Patients will be made attentive that no interventions can occur based on the study data and 
that they should present themselves at the ED/general practitioner (GP) if they experience any 
clinical deterioration.  

 
 
- 
Patients might lose interest in wearing the Oura ring, which will be picked up by the study team 
as they will review the data twice a week. In order to uphold the compliance rate, the study 
team will contact the patient in trying to motivate the patient into wearing the ring. The 
number of contacts will also be recorded to get a good estimation of the actual compliance 
rate.  
- 
Data security: patient that might have concerns on who has access to their data will be 
mitigated because a pseudonymized email is used. Therefore, only the PI and study team will 
know the identity of the patient (and this information is of course not available to Oura).  
 
Benefits 
This study will provide no direct benefit to the participating patients, however it does create very 
valuable insights:  
- 
The added value of in-home monitoring (i.e., remote monitoring system) of the vital signs can 
be investigated via changes in trends/vital signs 
- 
Use of the remote monitoring system within this population will also be addressed (i.e., via the 
compliance rate and the number of contacts that have been made) 
- 
A theoretical assumption can be made on the effect of the remote monitoring system on the 
number of ED visits and complications of the patient 
- 
Phenotyping the patient will also provide valuable insights on where the remote monitoring 
system could play a supportive role  
- 
The burden and advantages of the remote monitoring system can be assessed 
14. STATISCIAL ANALYSIS 
14.1 Statistical hypothesis 
The main hypothesis is to investigate the insights the remote monitoring system can provide on vital 
signs and trends prior to an ED visit and/or clinical deterioration of the patient (i.e., time-to-ED-visit).  
 
14.2 Sample size calculation 
The sample size calculation is only described for the prospective feasibility study.  
Currently patient-reported outcome measures are being used in the lung cancer patient population to 
assess their health remotely. However, applying a remote monitoring system using a wearable (i.e., 
Oura ring) has to our knowledge not been conducted (only for symptom management or to report 
PROMs). As this prospective feasibility study also does not imply an intervention based on the study 
data and the predefined objectives cannot be translated to means to determine the sample size, a 
sample size of 50 patients is determined.  
 
14.3 Statistical analysis plan 
Retrospective study  
The retrospective study will mainly be descriptively described (means, %, standard deviations and 
interquartile ranges). Difference in phenotyping between groups will be done using the appropriate 
type of test, dependent on the distribution (t-test, Mann-Whitney-U test, etc.).  
Prospective feasibility study  
Mainly descriptive statistics will be used to describe the patient population and compliance rate. 

 
 
 
15. ETHICAL CONSIDERATIONS 
The study will be conducted according to the legal and regulatory requirements outlined in the 
guidelines for Good Clinical Practice (International Conference on Harmonization), the most recent 
version of the Declaration of Helsinki,  the Belgian law of May 7th 2004 regarding experiments on the 
human person (as amended) the EU GDPR 2016/679, the relevant Belgian laws implementing the 
GDPR, the Belgian Law of August 22nd 2002 on patient rights, the sponsor’s applicable standard 
procedures, and other regulatory requirements as applicable. 
 
15.1 Ethics Committee review and reports 
Prior to the start of this study, this protocol and other related documents (e.g. ICF, questionnaires, 
etc.) will be submitted for review to the EC as well as to all ECs of the participating sites. The study will 
not start until approval has been obtained. Any subsequent protocol amendments will be submitted 
to the appropriate EC to seek approval. 
Additionally, an Annual Progress Report on a yearly basis will be submitted to the EC and the EC will 
be notified of the end of study. In case the study would be ended prematurely, this will be notified to 
the EC and the notification will include the reasons for premature termination. After termination of 
the study a summary of the study results will be submitted to the EC.  
 
15.2 Amendments 
Unless for urgent reasons as specified in ICH-GCP E6(R2) section 4.5.4, substantial amendments will 
not be implemented prior to EC review and approval, as applicable.  
A “substantial amendment” is defined as any change to any aspect of the clinical trial which is made 
and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability 
and robustness of the data generated in the clinical trial. 
 
15.3 General Data Protection Regulation 
The investigator and the participating site will treat all information and data relating to the study as 
confidential and will not disclose such information to any third parties or use such information for any 
purpose other than the performance of the study.  
The identity of the participant will be kept confidential according to the GDPR of 27 April 2016 (in 
application on 25 May 2018), to the Belgian law of 30 July 2018 on the protection of natural persons 
with regard to the processing of personal data and the Belgian patient’s right law (22 August 2002). 
Personal data will be coded. Participants will be assigned a unique identifier code. Participants will not 
be identified by name or in any other recognizable way in any of the records, results or publications 
related to the experiment. Any records or datasets that are transferred to the sponsor will contain the 
unique identifier only. Participant data should be kept in a secure location. Access to participant data 
will be limited to authorized study members only. 
 
16. DATA MANAGEMENT 
16.1 Data collection tools 

 
 
Source data will be collected and recorded by the PI and his/her study team in the electronic and/or 
paper patient file of the subject. Patient reported outcomes will be collected via electronic 
questionnaires that will be filed in an electronic case report form. 
The central database that will be used to collect study data is Castor. Access to this database will be 
granted to the investigator and appointed study members. CASTOR EDC complies with all applicable 
medical data privacy laws and regulations: GCP, 21 CRF Part 11, EU Annex 11, the European Data 
Protection Directive, ISO9001 and ISO27001/NEN7510. 
 
16.2 Data handling 
The PI and his/her study team (under supervision of the PI) are responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. All source documents should be 
completed in a neat, legible manner to ensure accurate interpretation of data.   
Collected study data will be transcribed from the source documents into the eCRF by the PI or his/her 
study team. This will be done as soon as possible after the visit took place. 
All data that will be provided to the sponsor will be pseudonymized. Every subject receives a unique 
study number upon enrolment in the study. This unique number can only be linked to the participant 
through a subject identification file, containing at least the subject’s name, date of birth, hospital ID 
and unique study number. It is the responsibility of the PI to safeguard the subject identification file. 
 
16.3 Data storage 
Specify the length of time the PI has to retain all records pertaining to this study after study completion 
and how these records need to be stored during the study and after study completion. Indicate whether 
permission is required (and from whom) prior to destruction of records. The following sentences can be 
used to describe the data storage: 
All source data needs to be retained by the PI for a minimum period of or 20 years after study 
completion. Both during the study and after study termination, source documents will be stored in a 
secured location with restricted access. No records may be destroyed during the retention period 
without written approval of the sponsor. 
 
17. MONITORING, AUDIT AND INSPECTION 
17.1 Monitoring 
In accordance with ICH-GCP E6(R2) the Sponsor is responsible for monitoring the study to ensure 
compliance with GCP and current legislation, and to verify, among other requirements, that proper 
written informed consent has been obtained and documented, that the study procedures have been 
followed as shown in the approved protocol, and that relevant study data have been collected and 
reported in a manner that assures data integrity. Therefore, source data will be compared with the 
data recorded in the eCRF. Remote and on-site monitoring of the study will be performed by qualified 
individuals (independent from the site study staff) according to the monitoring plan.  The 
PI/participating site will permit direct access to the study data and corresponding source data and to 
any other study related documents or materials to verify the accuracy and completeness of the data 
collected. More details about the monitoring strategy are described in the study specific monitoring 
plan. 

 
 
The study monitoring plan has been developed on the trial risk assessment which will be done by 
exploring the study dataset and performing site visits. 
 
17.2 Audit and inspection 
The PI will permit direct access to study data and documents for the purpose of monitoring, audits 
and/or inspections by authorized entities such as but not limited to: the sponsor or its designees and 
competent regulatory or health authorities. As such eCRFs, source records and other study related 
documentation (e.g. the investigator site file, pharmacy records, etc.) must be kept current, complete, 
and accurate at all times. 
 
18. PUBLICATION AND DATA SHARING POLICY 
The sponsor will manage study publications with the goal of publishing findings from the data. 
Publications will adhere to authorship criteria defined by the International Committee of Medical 
Journal Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org). Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. Authors must at a minimum meet all of the conditions 
below: 
- 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data; AND 
- 
Drafting the article or revising it critically for important intellectual content; AND 
- 
Final approval of the version to be published; AND 
- 
Agreement to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
All investigators not listed as co-authors will be acknowledged as the “Study Investigators” and will be 
individually listed according to the guidelines of the applicable scientific journal when possible. Any 
other contributors will be acknowledged by name with their specific contribution indicated. Based on 
the recruitment, site investigators might also be part of the Authorship. 
 
Considering that ongoing research contributing to the completion of datasets must not be 
compromised by premature or opportunistic sharing and analysis of data, the sponsor will not release 
the data of this study until the primary study results have been published, unless authorized for release 
has been granted.  
The sponsor follows the European FAIR principle (Findable – Accessible – Interoperable – Reusable) 
and acknowledges that data need to be open as possible and as closed as necessary. 
 
19. INSURANCE 
In accordance with the Belgian Law relating to experiments on human persons dated 07 MAY 2004, 
the sponsor will assume, even without fault, the responsibility of any damages incurred by a participant 
and linked directly or indirectly to the participation to the study and will provide compensation for the 
damages. The sponsor will therefore take out a no-fault insurance. The participating site will ensure 
appropriate insurance to meet the potential legal liability of the investigators/collaborators arising 
from harm to participants in the conduct of the study.   
 

 
 
20. REFERENCES 
1. 
Registry BC. Cancer Fact Sgeets - Lung cancer, http://kankerregister.org/Cancer_Fact_Sheets 
(2020). 
2. 
Kuderer NM, Dale DC, Crawford J, et al. Impact of primary prophylaxis with granulocyte colony-
stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving 
chemotherapy: a systematic review. J Clin Oncol 2007; 25: 3158-3167. DOI: 10.1200/jco.2006.08.8823. 
3. 
Rao KV and Faso A. Chemotherapy-induced nausea and vomiting: optimizing prevention and 
management. Am Health Drug Benefits 2012; 5: 232-240. 
4. 
Demedts I, Himpe U, Bossuyt J, et al. Clinical implementation of value based healthcare: Impact 
on outcomes for lung cancer patients. Lung Cancer 2021; 162: 90-95. 20211025. DOI: 
10.1016/j.lungcan.2021.10.010. 
5. 
Basch E, Deal AM, Dueck AC, et al. Overall Survival Results of a Trial Assessing Patient-Reported 
Outcomes for Symptom Monitoring During Routine Cancer Treatment. Jama 2017; 318: 197-198. DOI: 
10.1001/jama.2017.7156. 
6. 
Cavanna L, Citterio C and Orlandi E. Feasibility and Utility of Incorporating Patient-Reported 
Outcomes into Surveillance Strategies for Advanced Lung Cancer. Patient Relat Outcome Meas 2020; 
11: 49-66. 20200213. DOI: 10.2147/prom.S179185. 
7. 
Issa TZ, Lee Y, Toci GR, et al. The role of socioeconomic factors as barriers to patient reported 
outcome measure completion following lumbar spine fusion. The Spine Journal 2023; 23: 1531-1539. 
DOI: 10.1016/j.spinee.2023.05.003. 
8. 
Aiyegbusi OL, Roydhouse J, Rivera SC, et al. Key considerations to reduce or address 
respondent burden in patient-reported outcome (PRO) data collection. Nature Communications 2022; 
13: 6026. DOI: 10.1038/s41467-022-33826-4. 
9. 
Deloitte. Gebrek aan vertrouwen in verkopers van tweedehands telefoons staat duurzaamheid 
in de weg, https://www2.deloitte.com/content/dam/Deloitte/be/Documents/about-deloitte/press-
releases/digital-consumer-trends-2022_deloitte-be_press-release_nl.pdf. 
 
 

 
 
21. Appendix 
21.1 Declaration of conformity Oura Ring and charger 
EU Declaration of Conformity 
Model name: Gen3 and Gen3 charger 
Address: Ōura Health Oy, Elektroniikkatie 10, 90590 Oulu, Finland 
This declaration of conformity is issued under the sole responsibility of the manufacturer. Object of 
the declaration, this is identification of the radio equipment allowing traceability; 
 
The object of the declaration described above is in conformity with the relevant Community 
harmonisation: 
- 
Directive2014/53/EU–RadioEquipment  
- 
Directive2011/65/EU-RoHS  
- 
Directive2012/19/EU–WEEE 
The conformity with the essential requirements of the following directives has been demonstrated 
against the standards: 
 
Standard reference 
Article of Directive 2014/53/EU 
EN 62368-1:2014 + AC:2015 + A11:2017 
EN 62479:2010 
 
3.1 (a): Health and Safety of the 
User 
Draft ETSI EN 301 489-1 V2.2.3, 
 
EN 301 489-17 V3.2.4 
 

 
 
EN 55011:2016/A1:2017 EN 61000-6-1:2007 
EN 61000-6- 
 
3.1 
(b): 
Electromagnetic 
Compatibility 
3:2007/A1:2011/AC:2012 
 
EN 62233:2008/AC:2008 
 
ETSI EN 300 328 v2.2.2 
3.2 : Effective use of spectrum 
allocated 
The Notified Body (Dekra, 1909) has performed the documentation assessment of the product and 
issued the EU-Type Examination Certificate according to directive 2014/53/EU. Thus, CE is placed on 
the product. The Technical Documentation (TD) relevant to the product described above and which 
supports this Declaration of Conformity, is held at: Ōura Health Oy, Elektroniikkatie 10, 90590 Oulu, 
Finland. ŌURA is the company behind the Oura Ring — a wearable health platform that delivers 
personalized health data, insights and daily guidance. At ŌURA, our mission is to empower every 
person to own their inner potential. We believe health is a daily practice and, with insights and 
guidance, you can control the course of your health to live a more balanced life. The Oura Ring Gen3 
is smarter and more comprehensive than ever. Your daily health guide for a balanced life, with 24/7 
health tracking and personalized insights that translate your body's hidden messages and have the 
power to transform how you feel, day and night. Updated with our new, more accurate, state-of-the-
art sleep staging algorithm, daytime and workout heart rate monitoring, blood oxygen (SpO2) sensing, 
Period Prediction, and so much more. 
 
Signed for and on behalf of Ōura Health Oy, in San Francisco 10/11/2021 
Michael Chapp 
 
 
 
 
 

 
 
EU Declaration of Conformity 
Model name: OURA and OURA charger 
Address: Ōura Health Oy, Elektroniikkatie 10, 90590 Oulu, Finland 
This declaration of conformity is issued under the sole responsibility of the manufacturer 
Object of the declaration, this is identification of the radio equipment allowing traceability;  
 
 
The object of the declaration described above is in conformity with the relevant Community 
harmonisation: 
- 
Directive2014/53/EU–RadioEquipment  
- 
Directive2011/65/EU-RoHS  
- 
Directive2012/19/EU–WEEE 
The conformity with the essential requirements of the following directives has been demonstrated 
against the standards: 
Standard reference 
Article of Directive 2014/53/EU 
EN 60950-1:2006 + A11:2009 + 
 
A1:2010 + A12:2011 + AC:2011 + 
3.1 (a): Health and Safety of the 
A2:2013 
User 
EN 62479:2010 
 
Draft ETSI EN 301 489-1 V2.2.0 
 
(2017-03) Draft EN 301 489-17 
V3.2.0 (2017-03) 
EN 55011:2016/A1:2017 
 
3.1 
(b): 
Electromagnetic 
Compatibility 
EN 61000-6-1:2007 
 

 
 
ETSI EN 300 328 v2.1.1 (2016-11) 
3.2 : Effective use of spectrum 
allocated 
 
The Notified Body (Dekra, 1909) has performed the documentation assessment of the product and 
issued the EU-Type Examination Certificate according to directive 2014/53/EU. Thus, CE is placed on 
the product. The Technical Documentation (TD) relevant to the product described above and which 
supports this Declaration of Conformity, is held at: Ōura Health Oy, Elektroniikkatie 10, 90590 Oulu, 
Finland. OURA is a revolutionary wellness ring and app, designed to help user to get more restful sleep 
and to perform better. It enables user to learn how the lifestyle choices affect user's sleep, and how 
the quality of the sleep affects user's ability to perform. The OURA ring can automatically tell when 
user is sleeping. When user goes to sleep, the OURA ring analyzes the quality of the rest and recovery 
by measuring the heart rate (optically), respiration rate, body temperature, and movement. While user 
is awake, it monitors the duration and intensity of the activities, and the time user spends sitting. The 
OURA app integrates and visualizes this data to identify patterns between the sleep quality and daily 
activities. By understanding how well user slept and recharged, it can determine the readiness to 
perform and help user adjust the intensity and duration of the day's activities. It can also uncover 
actionable insights for changes to the daily activities that can help user sleep better. 
 
Signed for and on behalf of Ōura Health Oy, in Oulu 27/6/2018  
Michael Chapp 
 
 
 
 

 
 
EU Declaration of Conformity 
 
 
We Oura Health Oy Elektroniikkatie 10 90590 Oulu Finland Declare under our sole responsibility that 
the following products Equipment: Wellness ring Brand name: Oura Model/type: LE1 is in conformity 
with the Directive 2014/53/EU (RED) Directive 2011/65/EU (RoHS) and the following standards and 
technical specifications have been applied: 
RF spectrum use 
EN 300 328 V2.2.2 
 
 
EN 301 489-1 V2.2.3 
 
EN 301 489-17 V3.2.4 
EMC (article 3.1b) 
EN 55011:2016/A11:2020 
 
EN 61000-6-1:2017 
 
EN 61000-6-3:2021 
 
 
EN 62368-1:2014 + AC:2015 + 
Health & Safety 
AC:2017 + A11:2017 
 
EN 62479:2010 
 
Signed for and on behalf of Ōura Health Oy, in Oulu 24.03.2022  
Jyri Suokas 
Senior Quality Specialist 

 
Protocol 
ETERNALS 
 
 
Document identification 
Version No: v1  
Version Date: 21NOV2023 
 
Page 33 of 37 
TEMP –101, Version 1.0 
Effective date: 19JUN2023 
 
EU Declaration of Conformity 
We Oura Health Oy Elektroniikkatie 10 90590 Oulu Finland Declare under our sole responsibility that the 
following products Equipment: Inductive Charger Brand name: Oura Model/type: LE1 Charger  
is in conformity with the Directive 2014/30/EU (EMC) Directive 2011/35/EU (LVD) 
and the following standards and technical specifications have been applied: 
 
 
 
EN 55011 (2016)/ A11 (2020) 
2014/30/EU (EMC) 
EN 61000-6-1 (2017) 
EN 61000-6-3 (2021) 
 
EN 62368-1:2014 + AC: +2015 
2011/35/EU (LVD) 
AC:2017 + A11:2017 
EN 62233 (2008)/ AC (2008) 
 
Signed for and on behalf of Ōura Health Oy, in Oulu 24.03.2022  
Jyri Suokas 
Senior Quality Specialist

 
Protocol 
ETERNALS 
 
 
Document identification 
Version No: v1  
Version Date: 21NOV2023 
 
Page 34 of 37 
TEMP –101, Version 1.0 
Effective date: 19JUN2023 
 
21.2 Screening log 
Protocol info 
Title 
ETERNALS 
Number 
Z2023080 
Version 
V1 
Date 
23NOV2023 
 
 
Patient Name 
Suffices to all inclusion 
criteria 
Does not comply to any 
exclusion criterion 
Date of 
screening 
(DDMMYY) 
Investigator Name 
Investigator signature 
 
☐ In possession of a 
smartphone   
☐ Diagnosed with stage IV 
lung cancer and 
being(/planned to be) 
treated with cytotoxic 
chemotherapy 
☐ Older than 18 years of 
Age 
 
☐ Life expectancy of less 
than 6 weeks 
 
☐ Not able to understand 
the Dutch Language 
 
 
 
 
 
 
 
☐ Patient is in possession 
of a smartphone   
☐ Diagnosed with stage IV 
lung cancer and 
being(/planned to be) 
☐ Life expectancy of less 
than 6 weeks 
 
☐ Not able to understand 
the Dutch Language 
 
 
 

 
Protocol 
ETERNALS 
 
 
Document identification 
Version No: v1  
Version Date: 21NOV2023 
 
Page 35 of 37 
TEMP –101, Version 1.0 
Effective date: 19JUN2023 
 
treated with cytotoxic 
chemotherapy 
☐ Older than 18 years of 
Age 
 
 
☐ Patient is in possession 
of a smartphone   
☐ Diagnosed with stage IV 
lung cancer and 
being(/planned to be) 
treated with cytotoxic 
chemotherapy 
☐ Older than 18 years of 
Age 
 
☐ Life expectancy of less 
than 6 weeks 
 
☐ Not able to understand 
the Dutch Language 
 
 
 
 
 
 
 

 
Protocol 
Trial name/Acronym 
Trial Logo 
 
Document identification 
Version No: x.x  
Version Date: DDMMM20YY 
 
Page 36 of 37 
TEMP –101, Version 1.0 
Effective date: 19JUN2023 
 
Protocol info 
Title 
ETERNALS 
Number 
Z2023080 
Version 
V1 
Date 
23NOV2023 
 
 
Patient Name 
Suffices to all inclusion 
criteria 
Does not comply to any 
exclusion criterion 
Date of 
screening 
(DDMMYY) 
Investigator Name 
Investigator signature 
 
☐ In possession of a 
smartphone   
☐ Diagnosed with stage IV 
lung cancer and 
being(/planned to be) 
treated with cytotoxic 
chemotherapy 
☐ Older than 18 years of 
Age 
 
☐ Life expectancy of less 
than 6 weeks 
 
☐ Not able to understand 
the Dutch Language 
 
 
 
 
 
 
 
☐ Patient is in possession 
of a smartphone   
☐ Diagnosed with stage IV 
lung cancer and 
being(/planned to be) 
treated with cytotoxic 
chemotherapy 
☐ Life expectancy of less 
than 6 weeks 
 
☐ Not able to understand 
the Dutch Language 
 
 
 

 
Protocol 
Trial name/Acronym 
Trial Logo 
 
Document identification 
Version No: x.x  
Version Date: DDMMM20YY 
 
Page 37 of 37 
TEMP –101, Version 1.0 
Effective date: 19JUN2023 
 
☐ Older than 18 years of 
Age 
 
 
☐ Patient is in possession 
of a smartphone   
☐ Diagnosed with stage IV 
lung cancer and 
being(/planned to be) 
treated with cytotoxic 
chemotherapy 
☐ Older than 18 years of 
Age 
 
☐ Life expectancy of less 
than 6 weeks 
 
☐ Not able to understand 
the Dutch Language