A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
Phase: NA
Conditions: Sleep Apnea
Sponsor: Ectosense NV

Cover sheet 
 
Title of the project 
A validation study of the NightOwl PAT-based home sleep apnea test. 
 
Protocol identifier and date 
NOVS V1.1 5th January 2020 (Redacted Version) 
 
Protocol amendments 
1 
 
Sponsor  
Ectosense NV 
Bosbessenlaan 19A, 3110 Rotselaar, Belgium 
 
Investigator 
Jagdeep Bijwadia M.D. 
 
Research site 
Plantation Laboratory West 
10059 NW 1st Court 
Plantation, FL 33324 
 
Plantation Laboratory East 
100 NW 82nd Avenue  
Suite 402 
Plantation, FL 33324 
 
Miami Lakes Laboratory 
7745 NW 146th Street 
Miami Lakes, FL 33016 
 
6274 Linton Blvd 
Suite 106 
Delray Beach, FL 33484 
 
Purpose and background 
 
Scientific objectives 
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, 
called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based 
analytics software. The sensor acquires accelerometer and photoplethysmographic data. The 
software derives actigraphy from the former, and blood oxygen saturation and peripheral 
arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's 
performance, we will compare the respiratory event index (REI), defined as the number of 
respiratory events per hour of sleep, derived by the NightOwl system, to the AHI obtained from 
manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea 
diagnosis. We will also compare the total sleep time (TST) derived by both systems. This study 
will be performed in a sleep lab environment.  
 

As of March 2017, the new clinical practice guideline for diagnostic testing for adult sleep 
apnea of the American Academy of Sleep Medicine (AASM) for the first time formulates a 
strong recommendation that both polysomnography (PSG) and home sleep apnea testing 
(HSAT) are appropriate diagnostic testing options for uncomplicated adult patients who are at 
increased risk of moderate to severe sleep apnea.1  
Collop et al.2 performed a comprehensive analysis of the evidence for HSAT devices to 
diagnose obstructive sleep apnea (OSA) in out-of-center settings. The authors concluded that 
testing devices that analyze changes in peripheral arterial tone (PAT) in combination with 
actigraphy and blood oxygen saturation (SpO2) are adequate to diagnose OSA in patient 
populations with a high pre-test probability.  
In this study, we wish to assess the performance of a system for the diagnosis of OSA that 
measures and analyzes the abovementioned parameters, called NightOwl. The system consists 
of a small sensor device which is placed on the fingertip and a cloud-based analytics platform. 
An illustration of the NightOwl sensor can be found in Figure 1.  
 
 
Figure 1: A photograph of the NightOwl sensor positioned on the index finger (source: 
https://www.resmed.com.au/sleep-apnea/sleep-study) 
 
It is designed to be self-applied and initiated by the patient by attaching the sensor to the 
fingertip by means of an adhesive patch.  
 
Justification for involving humans 
In order to investigate whether the NightOwl achieves adequate performance in deriving the 
REI, we need to apply it to subjects that are undergoing a simultaneous polysomnography study, 
which is the gold standard for sleep apnea diagnosis.   
 
Subjects 
 
Number of subjects 
100 
 
Gender of subjects 
No gender specific bias will be introduced in recruitment, such that the subject sample will 
approximate the gender distribution of subjects admitted to a sleep clinic for an overnight PSG. 
From previous clinical trials, we expect the gender distribution to be approximately 60% male 
and 40% female. We do not exclude pregnant women from participating in the study since we 

want to represent this population in our subject pool. As justified below, the NightOwl sensor 
poses negligible risk for the subject, pregnant or otherwise.  
 
Subjects age 
We aim to include subjects from the age of 13 and older. The American Academy of Sleep 
Medicine (AASM), which is the leading guideline body in sleep medicine, recommends using 
the adult criteria for the scoring of respiratory events for young adolescents of at least 13 years 
of age. The AASM recognized that this recommendation would provide the underserved 
adolescent population greater access to sleep studies. Hence in order to represent the full age 
range of subjects for which the adult scoring rules apply, and for which we want to validate our 
device, we aim to include subjects of 13 years of age and older.  
 
Racial and Ethnic Origin 
We aim to include sufficient enrollment of persons of diverse racial and ethnic backgrounds. 
We will not stratify the subject population on a racial or ethnical basis but will assume that the 
subjects population without stratification will represent subjects of a diverse racial/ethnic 
background because of the significant subject pool size.  
 
Inclusion criteria 
Subjects with an indication for an in-lab polysomnography 
 
Exclusion criteria 
Intellectually disabled people 
People younger than 13 years of age. 
 
Vulnerable Subjects:   
Children aged 13 or older will not be excluded (rationale provided in the Subjects age 
paragraph). Explicit consent of the parents will be required before inclusion. 
Pregnant women will not be excluded (rationale in the Gender of subjects paragraph).   
 
Methods and procedures 
 
Overview of study design and procedures 
The study is open-blind and non-randomized.  
 
During the PSG night: 
• Eligible patients will be invited to participate in the study and will be presented with the 
ICF.  
• If the ICF is accepted, the patient will undergo the scheduled in-lab PSG, in which the 
NightOwl sensor will be included. 
During each study night, the following flowchart will be followed: 

 
 
Figure 2 - Flowchart of study. Experimental signifies procedures that are performed exclusively for 
research purposes. 
 
 
Frequency and duration 
We aim to include between 10 and 19 subjects every study night. Each patient has one night of 
recording. 
 
Precautions 
No procedures, situations, or materials are deemed hazardous; hence no specific precautions 
are to be exercised.  See NightOwl Product Risk Analysis (attached) 
 
Sample collection 
Data of the PSG and NightOwl will be collected throughout the entire duration of the overnight 
PSG study.  
 
Detailed procedure for each study night 
For every patient scheduled for an overnight in-lab PSG, the clinical personnel in charge of 
administering the PSG will assess whether the patient is eligible for inclusion (does not violate 
the exclusion criteria) to the study (the patient passes the inclusion criteria since he/she has been 
scheduled for a PSG). Every eligible patient will be presented with the ICF. The patient can at 
all time ask for clarifications on the content of the ICF and will be provided with sufficient time 
to read the entire form. Upon signing of the ICF, the patient will be included in the study. For 
subjects aged under 22, parental consent is required.  
For each subject included during a particular night, the age, gender, height, and weight will be 
collected. Additionally, we will ask the subject for a self-report of his/her race and ethnicity. 
The following options will be provided:  
 
Patient selection (experimental)
Presentation of informed consent 
to targeted patients 
(experimental)
Application of PSG (standard of 
care) and NightOwl sensor 
(experimental)
Execution of scheduled PSG 
(standard of care) and activation 
of NightOwl sensor (experimental)

 
Table 1: Self-reported options for Ethnicity and Race 
 
The NightOwl sensor will be attached to the middle finger of the hand on which the pulse 
oximeter of the PSG is applied by means of a disposable adhesive fingerwrap. The NightOwl 
sensor will be switched on and connected to a smartphone on which the NightOwl Companion 
App is installed. The NightOwl Companion App continuously acquires the raw sensor data 
from the NightOwl Sensor and stores this data on its internal memory. After starting the 
acquisition of the NightOwl sensor data via the NightOwl Companion App, the PSG recording 
can be started. 
 
When the personnel press the ‘Wake up’ button in the NightOwl Companion App at the end of 
the PSG study, the data will be uploaded to a secure cloud server in which the raw NightOwl 
Sensor data is stored and on which the NightOwl Software, which analyses the data, is 
deployed.  
 
After pressing the ‘Wake up’ button in the NightOwl Companion App, the PSG equipment and 
NightOwl sensor will be detached from the subject. The NightOwl Sensor will be disinfected 
and cleaned. The following disinfectants can be used on the sensor: 
 
• Mikrozid 
• Clorox 
• Lysol 
• Cavicide 
• 70% Ethyl alcohol or isopropyl alcohol (IPA) 

 
 
 
Details of acquired dataset for each subject 
Throughout the study, the following data will be collected for each included subject: 
• Polysomnographic data (EDF format), by means of export from the sleep clinics’ PSG 
software  
• Respiratory events and sleep stages annotated by the sleep technician (EDF, TXT, or CSV 
format), by means of export from the sleep clinics’ PSG software 
• NightOwl sensor data, by means of export from the NightOwl database: 
o red and infrared PPG from finger (CSV) 
o accelerometry from finger (CSV) 
• Subject’s age, gender, weight, height, self-reported ethnicity, and self-reported race will 
be collected right before administering the PSG.  
 
Potential risks 
 
Risk Category 
The NightOwl sensor has been tested against IEC 60601-1 (Medical Device Electrical Safety) 
and IEC 60601-1-2 (Medical Device Electromagnetic Compatibility) standards. It is a low 
voltage device that contains an accelerometer and an optical sensor such as would be found in 
a traditional pulse oximeter. In the FDA guidance document “Pulse Oximeters - Premarket 
Notification Submissions [510(k)s]” it is stated that generally, FDA believes pulse oximeters 
addressed by this guidance document are non-significant risk devices. 
The Product Risk Analysis, conducted in accordance with ISO14971:2012; Application of Risk 
Management to Medical Devices, is attached.  There are no residual risks that considered to be 
unacceptable. 
Hence, risk of the research is considered minimal. the probability and magnitude of harm or 
discomfort anticipated in the research are not greater than those ordinarily encountered in daily 
life or during the performance of routine physical or psychological examinations or tests. 
 
Potential Risk and protection against such risk 
A non-serious risk for cytotoxicity or skin irritation caused by the sensor material being in 
continuous contact with the fingertip for the overnight recording could be identified. However, 
this risk is deemed negligible since the sensor enclosure material passed ISO10993-1 compliant 
tests for cytotoxicity and Direct Primary Skin Irritation.  
 
A risk for discomfort of the subject caused by the tight application of the NightOwl sensor to 
the finger exists. In order to mitigate this risk, the subject will be explicitly encouraged to either 
contact the clinical personnel to reapply the sensor more loosely or to detach the sensor from 
the finger.  
 
Potential Benefit 
There is no potential benefit for individual subjects 
 
Subject identification, recruitment, and consent/assent 
For every patient scheduled for an overnight in-lab PSG, the clinical personnel in charge of 
administering the PSG will assess whether the patient is eligible for inclusion (does not violate 
the exclusion criteria) to the study (the patient passes the inclusion criteria since he/she has been 
scheduled for a PSG). Every eligible patient will be presented with the ICF. The patient can at 

all time ask for clarifications on the content of the ICF and will be provided with sufficient time 
to read the entire form. The protocol will be discussed with the subject, all questions will be 
answered. The subject will explicitly be asked if all content was clear.  
Upon signing of the ICF, the patient will be included in the study. For patients aged under 22, 
parental consent is required and both parent and child will be asked if all content was clear. The 
consent forms will be stored. All ICFs will be entered into the IRB’s storage system in unlocked 
word form.  
 
The subject will incur no extra cost as a result of participating in the study. 
 
Compensation of subjects 
The subjects will receive no payment for participating in the study 
 
DATA AND CONFIDENTIALTIY 
 
HIPAA Compliance 
This study will be conducted in full accordance the HIPAA privacy rule. Any episodes of non-
compliance will be documented.  The investigators will perform the study in accordance with 
this protocol and will obtain consent (unless a HIPAA waiver of Consent is granted) and will 
report unexpected problems in accordance with institutional regulatory committee. Collection 
of data will be accurate and will ensure the privacy, health, and welfare of research subjects 
during and after the study. The principal investigator overseeing the conduct of this study and 
the research personnel will comply with the applicable federal, state, and local regulations 
governing clinical research and the protection of human research subjects.  
 
Study analysis 
. 
Two main performance analyses will be performed: 
• The evaluation of the Pearson correlation between the REI and TST estimate obtained 
from the NightOwl and the AHI and TST determined from the PSG; 
• The evaluation of the agreement between patient categorization (into sleep apnea 
severity categories) obtained by the NightOwl and those obtained by the manual 
analysis of the PSG. 
 
In order to establish an external benchmark to which the NightOwl and PSG analysis could be 
compared, the codified PSG data will be transferred to Younes Medical Technologies Ltd. 
(YMT), the corporation behind the Michele Sleep Scoring System (MSSS) developed by Dr. 
M. Younes. Malhotra et al.3 confirmed that the MSSS, complemented with manual editing, 
standardizes PSG scoring results within and across sleep centers. Using such external 
benchmark, the impact of inter-scorer variability of current and future reports on NightOwl’s 
performance metrics is reduced.  
Data Storage and Confidentiality 
The data will be stored in a cloud storage system (Google drive with activated Google Vault) 
protected by password, which is only known by the Principal Investigator and Sponsor. Google 
Vault is SSAE 16, SOC 2 audited, and ISO 27001 certified and was specifically designed for 
users to meet legal data retention requirements 
 

An audit trail of all changes made to data files can be reconstructed since each file addition and 
deletion is permanently logged. All data will be stored for at least 2 years after the completion 
of the study. All data belonging to the same subject will receive a unique patient code. This 
number will be composed of the center nr (1 to 4) followed by the enrolment nr of that subject 
(e.g. the third patient enrolled in center 1 will receive the nr 1-3).  
For each center, a coding table will be maintained in paper format which maps the patient code 
to the patient’s name. This coding table is securely stored and locked away when not in use and 
is temporarily maintained to allow for association between the NightOwl Sensor data (which is 
always coded such that the patient’s name is never transferred to Ectosense NV) and PSG 
(which is coded upon upload to the cloud storage system). As soon as all PSG and data of all 
subjects has been exported, coded, and uploaded, the coding table will be permanently 
destroyed by means of secure shredding in order to render the dataset stored on the cloud storage 
system anonymous.  
 
Only the anonymized data stored in the cloud storage system will be used for the analysis 
described above. Hence, none of the researchers performing the statistical analysis will have 
access to uncoded data. 
 
Questionnaires and data collection sheets 
 
1. Ethnicity and race self-reporting questionnaire.  
a. This questionnaire will be coded, scanned and uploaded to the cloud storage 
system for each subject. After uploading the physical copy will be securely 
shredded. 
b. This questionnaire is proposed by the FDA guidance document for the 
Collection of Race and Ethnicity Data in Clinical Trials. 
 

Table 1: Ethnical and racial self-reporting questionnaire 
 
 
2. Subject additional information sheet 
a. This information sheet will be coded, scanned and uploaded to the cloud storage 
system for each subject. After uploading the physical copy will be securely 
shredded. 
 
Table 2: Subject additional information sheet 
 
References 
1.  
Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical Practice Guideline for Diagnostic 
Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine 
Clinical Practice Guideline. J Clin Sleep Med. 2017;1313(3):479-504. 
doi:10.5664/jcsm.6506. 
2. 
Collop NA, Anderson WM, Boehlecke B, et al. Clinical guidelines for the use of 
unattended portable monitors in the diagnosis of obstructive sleep apnea in adult 
patients. Portable Monitoring Task Force of the American Academy of Sleep 

Medicine. J Clin Sleep Med. 2007;3(7):737–747.  
3.  
Malhotra A, Younes M, Kuna ST, et al. Performance of an automated 
polysomnography scoring system versus computer-assisted manual scoring. Sleep. 
2013;36(April 2013):573-82. doi:10.5665/sleep.2548.