A Single Center, Single Arm, Quantitative Study Assessing Performance of TatchSleep as a Tool to Aid in Sleep Apnea Analysis
Phase: NA
Conditions: Sleep Apnea, Sleep Disorder
Sponsor: Wesper Inc

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PROTOCOL NUMBER: TCH-110  
VERSION 1.1 
26-Apr-2021 
 
 
 
 
 
 
 
 
 
 
 
A Multi Center, Single Arm, Quantitative Study 
Assessing Performance of TatchSleep Pro as a 
Tool to Aid in Sleep Apnea Diagnosis 
 
 
 
 
Protocol Number: TCH-110  
Version 1.1 
26-Apr-2021 
 
Sponsor:  
Tatch, Inc. 
234 5th Avenue 
New York, NY 10001 
 
 
 
 
 
 
 

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PROTOCOL NUMBER: TCH-110  
VERSION 1.1 
26-Apr-2021 
 
Not for Distribution – Do Not Copy 
This study protocol contains confidential information and was developed by Tatch, Inc., the 
Principal Investigator and his/her designee. The protocol is for use by the Principal Investigator 
and his/her designated representatives participating in this investigational trial. This protocol 
may not be copied or made available for review by an unauthorized person or firm without the 
prior written authorization of Tatch®, Inc. 

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PROTOCOL NUMBER: TCH-110  
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Sponsor Protocol Approval 
 
I have read this protocol and approve the design of this study: 
 
 
 
 
 
Amir Reuveny, Tatch, Inc. PhD, CEO 
 
 
 
 
 
Date 
 

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Investigator Protocol Approval 
 
I agree to the terms of this study protocol. I will conduct the study according to the procedures 
specified herein, and according to principles of Good Clinical Practice and local regulations and 
requirements. 
 
Institution/Clinic:  
___________________________________________ 
 
Principal Investigator: 
 
Print Name:  ______________________________________ 
 
Signature: 
 
______________________________________ 
 
Date (dd/mm/yyyy): ______________________________ 
 
 
 
 
 
 
 
 
 

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Table of Contents 
Sponsor Protocol Approval ........................................................................................................ 3 
Investigator Protocol Approval .................................................................................................. 4 
Table of Contents ...................................................................................................................... 5 
1. Protocol Synopsis ............................................................................................................... 7 
2. Background and Rationale ............................................................................................... 11 
3. Study Objectives ............................................................................................................... 12 
3.1 Primary Objective .......................................................................................................... 12 
3.2 Secondary Objectives ................................................................................................... 12 
4. Study Endpoints ................................................................................................................ 12 
5. Study Overview ................................................................................................................. 13 
6. Study Population ............................................................................................................... 13 
6.1 Inclusion Criteria ............................................................................................................ 14 
6.2 Exclusion Criteria .......................................................................................................... 14 
7. Patient Recruitment .......................................................................................................... 14 
8. Study Procedures and Assessments ................................................................................ 14 
8.1 Eligibility Assessment and Informed Consent ................................................................ 14 
8.2 Urine Pregnancy Test .................................................................................................... 15 
8.3 Complete Patient Case Report Form (CRF) .................................................................. 15 
8.4 Polysomnography .......................................................................................................... 15 
8.5 TatchSleep Pro Administration ...................................................................................... 15 
8.6 Follow-up Communication ............................................................................................. 15 
8.7 Onsite PSG Study Scoring and Export .......................................................................... 16 
9. Study Scoring ................................................................................................................... 16 
9.1 Scoring Population ........................................................................................................ 16 
9.2 Reasons for Data Exclusion .......................................................................................... 16 
9.3 Blinding.......................................................................................................................... 16 
9.4 Scoring Procedure ......................................................................................................... 17 
9.5 AHI Calculation .............................................................................................................. 17 
10. Reader Selection .............................................................................................................. 18 
11. TatchSleep Pro Materials and Management ..................................................................... 18 

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11.1 
TatchSleep Pro Description ...................................................................................... 18 
11.2 
Shipping, Storage and Accountability ....................................................................... 18 
11.3 
TatchSleep Pro Associated Risks ............................................................................. 19 
12. Adverse Events ................................................................................................................. 19 
12.1 
Adverse Event Definition .......................................................................................... 19 
12.2 
Severity ..................................................................................................................... 20 
12.3 
Serious Adverse Events (SAE) and Unanticipated Adverse Device Effect (UADE) .. 20 
12.4 
Event Reporting ........................................................................................................ 21 
13. Early Termination .............................................................................................................. 21 
14. Data Analysis .................................................................................................................... 21 
14.1 
General Considerations ............................................................................................ 21 
14.2 
Analysis Population .................................................................................................. 21 
14.3 
Safety Population...................................................................................................... 22 
14.4 
Demographics .......................................................................................................... 22 
14.5 
Primary Outcome Evaluation .................................................................................... 22 
14.6 
Secondary Outcomes Evaluation.............................................................................. 23 
14.7 
Primary Safety Evaluation ........................................................................................ 23 
14.8 
Sample Size ............................................................................................................. 23 
15. Study Administration ......................................................................................................... 24 
15.1 
GCP Statement......................................................................................................... 24 
15.2 
Informed Consent ..................................................................................................... 24 
15.3 
Institutional Review Board ........................................................................................ 24 
15.4 
Sponsor Monitoring ................................................................................................... 25 
15.5 
Documentation and Intended Use of Data ................................................................ 25 
15.6 
Record Retention ...................................................................................................... 25 
16. References ....................................................................................................................... 26 
Appendix 1 – Bland-Altman LOA Meta-Analysis ..................................................................... 27 

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1. 
Protocol Synopsis 
 
Name of Sponsor:  Tatch, Inc.  
Protocol Number: TCH-110 
Protocol Tittle: 
A Multi Center, Single Arm, Quantitative Study Assessing 
Performance of TatchSleep Pro as a Tool to Aid in Sleep 
Apnea Diagnosis 
 
Investigational 
Device: 
TatchSleep Pro 
Study Centers: 
Approximately 3 
Study Objectives: Primary Objectives: 
• Demonstrate clinical agreement between TatchSleep 
Pro and PSG signals by comparing the Apnea 
Hypopnea Index (AHI) values derived from a clinical 
reading of each set of signals. 
 
Secondary Objectives: 
• Compare TatchSleep Pro and PSG signals across 
different positions and in the presence of motion. 
• Evaluate the reliability of TatchSleep Pro signals 
across readers. 
Endpoints: 
Primary Effectiveness Endpoints: 
• Agreement between the AHI as determined by TatchSleep 
Pro and PSG signals as measured by the Pearson 
correlation. 
• Bland-Altman 95% limits of agreement for TatchSleep Pro 
and PSG AHI 
 
Secondary Effectiveness Endpoints: 
• Deming regression parameters estimated by weighted 
regression of TatchSleep Pro AHI on PSG AHI. 
• Estimation of the inter-rater reliability for TatchSleep 
Pro AHI. 
• Estimation of the agreement between diagnoses of 
mild, moderate and severe sleep apnea based on 
TatchSleep Pro and PSG AHI. 

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• Estimation of the Bland-Altman 95% limits of 
agreement of TatchSleep Pro and PSG AHI by 
position (supine v. non-supine). 
Primary Safety Endpoints: 
• Incidence of Adverse Events (AEs) and Serious Adverse 
Events (SAEs) related to the device throughout the study 
period. 
Study Design: 
 
 
 
 
This is a multi-center, single-arm, quantitative study evaluating 
the effectiveness of the TatchSleep Pro wireless sensors as a 
tool to aid in sleep apnea diagnosis as compared to an overnight 
PSG evaluation.  
 
Investigators will identify approximately 50 eligible patients who 
have been recommended to receive an overnight PSG for the 
detection/evaluation of sleep apnea. After informed consent is 
obtained, a brief sleep-related medical history will be collected 
including relevant demographics. Females of childbearing 
potential will be asked to undergo a urine dipstick pregnancy test 
to determine their eligibility for inclusion in the study.  
 
Patients will undergo their PSG test while simultaneously 
wearing 2 TatchSleep Pro patches and an FDA-cleared pulse 
oximeter compatible with and connected to the TatchSleep Pro 
system for a single night at the clinic.  The same make and model 
of pulse oximeter will be used for all subjects. Patients will be 
observed overnight by trained sleep technicians who will setup 
the TatchSleep Pro device and collect the sleep data via the 
companion smartphone application.  
 
A follow-up communication will be made with patients within 5 
days after the sleep study to assess any adverse events. 
 
Following the data collection, sleep data from PSG and 
TatchSleep Pro will be scored by an independent qualified sleep 
technologist (the primary reader) to yield an analysis of the 
accuracy of TatchSleep Pro compared with the PSG signals.  At 
least one and up to two additional readers (secondary readers) 
will score only the TatchSleep Pro data to obtain an estimate of 
inter-rater reliability. 
 
Study Device: 
TatchSleep Pro paired with the same make and model of 
compatible FDA cleared pulse oximeter for all subjects 
Eligibility Criteria: Inclusion Criteria:  
1. Be at least 21 years of age. 

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2. Have a referral to the study site from a physician to 
complete an overnight polysomnogram test for sleep apnea 
detection or follow-up. 
3. Be willing and able to wear two TatchSleep Pro patches 
and an FDA-cleared pulse oximeter in conjunction with a 
polysomnogram, for a single night. 
4. Be able and voluntarily willing to sign a written informed 
consent form prior to the initiation of any study procedures. 
Adult patients unable to provide written informed consent 
on their own behalf will not be eligible for the study.  
 
Exclusion Criteria: 
1. Women who are pregnant, trying to get pregnant or who 
have a positive urine pregnancy test on the day of the 
study.    
2. Women who are breast-feeding 
3. Significant cardiorespiratory disease 
4. Potential 
respiratory 
muscle 
weakness 
due 
to 
neuromuscular condition 
5. Awake hypoventilation or suspicion of sleep related 
hypoventilation 
6. Chronic opioid medication use 
7. History of stroke 
8. History of severe insomnia 
9. Any known health condition that, in the opinion of the 
Investigator, would exclude the patient from participating in 
the study.  
Number of  
Patients: 
Approximately 50 
Data Elements: 
The following data elements will be collected: 
• Height, weight, age, gender, skin tone (according to the 
Fitzpatrick scale), presence or lack of body hair under 
TatchSleep Pro patches. 
• TatchSleep Pro data (including patient movement, sleep 
position, pulse oximetry, and respiration) 
• PSG data (including sleep stages, total sleep time, sleep 
position, pulse oximetry, heart rate, and respiration). 
• Adverse events 
Statistical 
Methods: 
Accuracy of the TatchSleep Pro device will be demonstrated by 
comparing the Pearson correlation of TatchSleep Pro and PSG 
AHI to a performance goal. The performance goal is based on a 
meta-analysis 
of 
FDA-cleared 
similar 
devices. 
Fisher's 
transformation and one-sided Z-test will be used to test the 
hypotheses with a significance level of 0.025. The upper and 
lower 95% Bland-Altman limits of agreement will be calculated 
and statistically compared using a Wald test to performance 
goals based on a meta-analysis of FDA-cleared similar devices. 

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Deming regression will also be presented. The inter-rater 
reliability of TatchSleep Pro AHIs will be calculated. 

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2. Background and Rationale 
 
Obstructive sleep apnea (OSA) is characterized by reduced breathing and breathing 
cessation during sleep. It is a highly prevalent condition that affects an estimated 14% of 
adult men and 5% of adult women aged 30 to 70 [1]. OSA is associated with more than 
30 chronic conditions, such as increased risk of cardiovascular complications, and 
daytime fatigue and sleepiness. While the clinical gold standard for the diagnosis of OSA 
is polysomnography, these in-laboratory tests are expensive, time consuming, and labor 
intensive. 
In recent years there is a growing use of home sleep tests (HSTs) as a more convenient 
and cost-effective alternative to diagnose sleep disorders. Nevertheless, HSTs currently 
on the market contain several complex wires and tubes that may make it difficult for 
patients to use on their own. In addition, patients report that they can be intrusive and 
uncomfortable. These factors lead to unreliable data collection and ineffective diagnosis 
of OSA [2]. 
TatchSleep Pro is a system comprised of flexible, thin, and wireless adhesive patches, 
coupled with an FDA-cleared compatible pulse oximeter, for the detection of sleep apnea. 
The wearable sensors detect various physiological parameters related to sleep quality, 
including respiration, SpO2, and sleep position, and transmits data wirelessly to a 
smartphone app in real time. The data recorded by the patches is relayed to remote secure 
storage, from where it is downloaded to a local PC. The study output file is prepared by 
Tatch staff for review by a qualified sleep scorer.  
The TatchSleep Pro device was bench-tested against industry standard polysomnography 
devices to compare the different sensors. Using its proprietary technology, TatchSleep 
Pro showed excellent accuracy and sensitivity in measuring respiration and sleep position. 
Previous feasibility testing was conducted on approximately 30 patients to evaluate the 
user experience and effectiveness in using the patch technology.  
As a low-cost and user-friendly home sleep testing system, TatchSleep Pro has the 
potential to improve the detection of OSA while reducing the burden on patients and 
providers caused by complicated and invasive sleep kits.  
 
In the current study, TatchSleep Pro will be evaluated as a tool to assist physicians in 
determining the overall Apnea Hypopnea Index (AHI) of a patient. Tatch, Inc. has 
partnered with the multiple clinical sites for this study.  
 
 
 

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3. Study Objectives 
 
3.1 Primary Objective 
 
• Demonstrate clinical agreement between TatchSleep Pro and PSG signals by 
comparing the Apnea Hypopnea Index (AHI) values derived from a clinical reading of 
each set of signals. 
 
3.2 Secondary Objectives 
• Compare TatchSleep Pro and PSG signals across different positions and in the 
presence of motion. 
• Evaluate the reliability of TatchSleep Pro signals across readers. 
 
4. Study Endpoints 
To support the study's objectives, the following endpoints will be calculated: 
 
Primary Effectiveness Endpoints: 
• Agreement between the AHI as determined by TatchSleep Pro and PSG signals as 
measured by the Pearson correlation. 
• Bland-Altman 95% limits of agreement for TatchSleep Pro and PSG AHI 
 
Secondary Effectiveness Endpoints: 
• Deming regression parameters estimated by weighted regression of TatchSleep 
Pro AHI on PSG AHI. 
• Estimation of the inter-rater reliability for TatchSleep Pro AHI. 
• Estimation of the agreement between diagnoses of mild, moderate and severe 
sleep apnea based on TatchSleep Pro and PSG AHI. 
• Estimation of the Bland-Altman 95% limits of agreement of TatchSleep Pro and 
PSG AHI by position (supine v. non-supine). 
 
Primary Safety Endpoint 
• Incidence of adverse events and serious adverse events (SAEs) related to the device 
throughout the study period. 
 
 

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5. Study Overview 
 
This is a multi-center, single-arm, quantitative study evaluating the effectiveness of the 
TatchSleep Pro wireless sensors as a tool to aid in sleep apnea diagnosis as compared 
to an overnight PSG evaluation. This study is intended to evaluate the performance of the 
TatchSleep Pro against PSG for the target population. 
 
Investigators will identify approximately 50 eligible patients who have been recommended 
to receive an overnight PSG for the detection/evaluation of sleep apnea. After informed 
consent is obtained, a brief medical history will be collected including relevant 
demographics.  Females of childbearing potential will be asked to undergo a urine dipstick 
pregnancy test to determine eligibility for study participation.  
 
Patients will undergo their PSG test while simultaneously wearing 2 TatchSleep Pro 
patches and a paired FDA-cleared compatible pulse oximeter for a single night at the clinic.  
The same make and model of pulse oximeter will be used for all subjects. Patients will be 
observed overnight by trained sleep technicians who will setup the TatchSleep Pro device 
and will record the sleep data via the companion smartphone application.  
 
A follow-up phone communication will be made with patients within 5 days after the sleep 
study to assess any adverse events. 
 
TABLE 1: SCHEDULE OF ASSESSMENTS 
 
Procedure or Assessment 
Study visit 
 
(Day -7 to Day 1) - 
Screening  
Day 1 - 
Night 
Day 2 - 
Morning 
 Day 3-7 
follow-up 
Informed Consent 
X 
 
 
 
Eligibility Assessment 
X 
 
 
 
Urine Pregnancy Test 
 
X 
 
 
Polysomnogram (PSG) 
 
X 
 
 
Administer TatchSleep Pro  
 
X 
 
 
Adverse Event Assessment 
 
X 
X 
 
Follow-up Communication 
 
 
 
X 
 
 
6. Study Population 
 
Approximately 50 participants at least 18 years of age will be enrolled in this study. These 
patients will be identified by a clinician to complete an overnight PSG test for sleep apnea 
detection or follow-up.  

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6.1 Inclusion Criteria 
Eligible participants must meet all of the following criteria: 
1. 
Be at least 21 years of age. 
2. Have a referral to the study site from a physician to complete an overnight PSG 
test for sleep apnea detection or follow-up. 
3. Be willing and able to wear two TatchSleep Pro patches and an FDA-cleared 
pulse oximeter in conjunction with a PSG, for a single night. 
4. Be able and voluntarily willing to sign a written informed consent form prior to the 
initiation of any study procedures. Adult patients unable to provide written 
informed consent on their own behalf will not be eligible for the study.  
 
6.2 Exclusion Criteria 
Participants in the study must not meet any of the following criteria: 
1. Women who are pregnant, trying to get pregnant or who have a positive urine 
pregnancy test on the day of the study. 
2. Women who are breast-feeding. 
3. Significant cardiorespiratory disease 
4. Potential respiratory muscle weakness due to neuromuscular condition 
5. Awake hypoventilation or suspicion of sleep related hypoventilation 
6. Chronic opioid medication use 
7. History of stroke 
8. History of severe insomnia 
9. Any known health condition that, in the opinion of the Investigator, would exclude 
the patient from participating in the study.  
 
7. Patient Recruitment 
Approximately 50 patients will be enrolled across 3 clinical sites. Potential patients who 
have been recommended to receive an overnight PSG for the detection/evaluation of 
sleep will be approached by key study personnel to discuss the study. Some of those 
patients might be referrals from fellow clinical sites or other healthcare providers that may 
or may not be aware of the study.  
 
8. Study Procedures and Assessments 
 
8.1 Eligibility Assessment and Informed Consent 
An informed consent form (ICF) must be signed by prospective patients prior to initiating 
any study-specific procedures.  
 
The Investigator or designee will confirm that the patient meets all inclusion and no 
exclusion criteria.  

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The patient must sign a written ICF prior to the initiation of any study procedures.  The 
enrolled subject will be given a signed copy of the ICF to take home. Adult subjects unable 
to provide written informed consent on their own behalf will not be eligible for the study. 
 
The ICF and any other written information provided to the patients will be revised 
whenever important new information becomes available that may be relevant to the 
patient's consent, or if there is an amendment to the protocol which necessitates a change 
to the content of the patient's informed consent. Any written ICF and written information 
must receive approval by the IRB in advance of use. Only the most up to date IRB-
approved ICF must be used to consent new patients. 
 
8.2 Urine Pregnancy Test 
Females of childbearing potential will be asked to undergo a urine dipstick pregnancy test 
on Day 1 in order to rule out pregnancy prior to starting the study.  
 
8.3 Complete Patient Case Report Form (CRF) 
CRFs will be provided for the recording of data. The Investigator or designee will record 
data from all observations and assessments specified in the protocol, including 
demographics, physical attributes and adverse events on the CRFs provided by the 
Sponsor.  
 
8.4 Polysomnography  
Patients will be hooked up to a PSG on Day 1 (Night) according to the standard of care at 
the clinical site.  This will record brain waves, blood oxygen level, heart rate and breathing, 
as well as eye and leg movements.   
 
8.5 TatchSleep Pro Administration 
 
The TatchSleep Pro will be connected to the patient by the investigator or designee 
according to the instructions in the provided User Manual. The investigator or designee 
will follow the instructions in the pre-loaded smartphone app to place the patches on the 
patient's chest and abdomen, as well as the pulse oximeter on the patient's finger. Once 
the sensors are set up and the participant is ready for bed, the investigator or designee 
will start the data collection using the app. 
 
Details about TatchSleep Pro management can be found in Protocol Section 11. 
 
8.6 Follow-up Communication 
A follow-up communication (email or phone call) will be made with patients within 5 days 
after the sleep study to check in on how they are doing and follow-up on any adverse 
events. If after three documented attempts the patient could not be reached for feedback, 
the patient will be considered as "lost to follow-up". 
 

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8.7 Onsite PSG Study Scoring and Export 
After the completion of data collection from patients, de-identified PSG signals will be 
exported from the PSG at the clinical site including, at a minimum, manual position 
annotations and sleep staging scored according to the standard of care by a sleep 
technologist at the study site. Raw PSG sleep data (including, at a minimum, respiratory 
effort, respiratory pressure, respiratory flow and oxygen saturation signals) will be 
extracted and presented to qualified readers as described below. 
 
9. Study Scoring 
Once study enrollment and all sleep tests are complete, and all exported PSG data (with 
position annotations and sleep staging) has been received by the Sponsor, the primary 
reader will score all sleep study recordings made simultaneously with TatchSleep Pro and 
the PSG device from all sites.  The primary reader will be blinded to the device used to 
collect the data under review as well as any information which may allow them to link the 
two studies from each patient.  The AHI will be calculated for each study, and the set of 
AHIs derived from TatchSleep Pro data will be compared with those derived from PSG 
data using Pearson correlation to demonstrate accuracy (see Protocol Section 11 for more 
details).  At least one and up to two additional readers (secondary readers) will each score 
all sleep study recordings made using the TatchSleep Pro device at all sites.  The AHIs 
derived from these scorings will be used to calculate the inter-rater reliability for the 
TatchSleep Pro device signals.  
 
9.1 Scoring Population 
Studies of subjects whose TatchSleep Pro recording does not encompass the sleep period 
indicated by PSG will not be scored [3].  Studies from all other participants who are 
enrolled, meet all the inclusion criteria and none of the exclusion criteria, and whose PSG 
study has >4 hours of sleep duration will be scored [3].   
 
9.2 Reasons for Data Exclusion 
Time periods marked by the reader as "Movement" or "Artifact" (collectively referred to as 
"invalid") in a study will not contribute to the total sleep time for the purpose of calculating 
AHI for that study (per guidelines in the American Academy of Sleep Medicine (AASM) 
Manual for the Scoring of Sleep and Associated Events section IX: Home Sleep Apnea 
Testing Rules for Adults).  Percentage of "invalid" time will be reported for each study. 
 
9.3 Blinding 
All studies will be presented on the same viewing and scoring platform.  The readers will 
be blinded to patient identification and the data collection device for each study.  
Specifically: 
 
• All data presented to the reader will be fully anonymized and will not include any 
information which could allow the reader to link a subject's two data sets.  All 
Protected Health Information (PHI), ID numbers, and study meta-data such as time 

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and date will be removed. 
• The reader will review patient studies in a predetermined randomized order such 
that sequential readings of data from the same patient will be avoided. 
• All studies will be reviewed using the same analysis software, and using identical, 
system-agnostic signal labeling (eg, "Flow" will be used to label both the 
TatchSleep Pro TATCH-SUM-FLOW and the PSG Airflow waveforms). 
 
9.4 Scoring Procedure 
Readers will be asked to score studies using the provided viewing software as they 
normally would in a clinical setting and in accordance with the AASM Manual for the 
Scoring of Sleep and Associated Events.  Hypopneas will be scored using the 
recommended rule 1A criterion as laid out in the AASM (v2.6), Chapter VIII Respiratory 
Rules Part 1: Rules for Adults, Section D: Scoring of Hypopneas. 
 
The same data channels will be presented to the reader in the same order and with the 
same labelling for every study, including: 
• Abdominal respiratory effort, labelled "ABD" from either the PSG system or the 
TatchSleep Pro patches, as applicable 
• Thorax respiratory effort, labelled "THX" from either the PSG system or the 
TatchSleep Pro patches as applicable 
• Position channel, labelled "Position" from either the PSG system or the 
TatchSleep Pro patches, as applicable 
• Air flow (PSG) or Tatch-Sum-Flow (TatchSleep Pro) as applicable, labelled "Flow" 
• Nasal pressure (PSG) or Tatch-Sum-Pressure (TatchSleep Pro) as applicable, 
labelled "Pressure" 
• Pulse oximetry-derived blood oxygen saturation (SpO2), labelled "SpO2" from 
either the PSG system or the TatchSleep Pro compatible pulse oximeter as 
applicable 
 
On any of the respiratory signals, the reader will be able to mark: 
• Apnea 
• Hypopnea 
 
On the SpO2 signal, the reader will be able to mark: 
• Relative desaturation 
 
Additionally, the reader may mark any signal with the following signal quality indicators: 
• Artifact 
• Movement 
 
9.5 AHI Calculation 
The AHI will be calculated for each study following scoring.  The PSG total sleep time (with 
device-specific total artifact time subtracted) will be used as the AHI denominator.   

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10. Reader Selection 
Sleep technologists of any age, sex, race, ethnicity, or institutional affiliation who are 
qualified to read PSG night tests may participate as study readers.  The selected readers 
must meet the following criteria: 
● 
Be Registered Polysomnographic Technologist (RPSGT) or Registered 
Sleep Technologist (RST) certified 
● 
Currently participant in the American Academy of Sleep Medicine Inter-
Scorer Reliability (AASM ISR) program 
● 
Be experienced in reading PSG night tests using at least one commercially 
available analysis software package 
● 
Have provided a current curriculum vitae (CV) 
● 
Have provided a signed Readers' Agreement 
 
The qualified and confirmed readers will complete a training program on the analysis 
software to be used for the study, as well as on the study protocol prior to their participation 
in this study. 
 
11. TatchSleep Pro Materials and Management 
 
11.1 TatchSleep Pro Description 
TatchSleep Pro is a system comprised of wearable and wireless sensors designed to 
collect physiological parameters related to sleep disorders in patients. The system has two 
sensor patches and makes use of a compatible FDA-cleared pulse oximeter.  Each patch 
consists of a wearable sensor and a bottom layer of double coat medical-grade adhesive. 
This adhesive is safe for patient use and enables the patch to stay affixed to the body 
(thorax and abdomen) throughout the night. The sensor also connects directly to a battery 
which is hidden within the patch.  During the study, patients will be asked to wear all three 
sensors (one patch on the abdomen, one patch on the thorax and the pulse oximeter on 
a finger).   Data from the patches and pulse oximeter are transmitted wirelessly throughout 
the night to a secure cloud server via the companion mobile application for clinicians to 
upload to a sleep analysis platform. 
 
11.2 Shipping, Storage and Accountability 
TatchSleep Pro sensors will be sent in packages to the clinical site by a tracked postal 
service prior to the enrollment of the patients. Each shipment will include up to 10 patient 
kits, depending on the site projected enrollment rate.  Each TatchSleep Pro kit will contain 
2 patches, a pulse oximeter, and a User Manual. Smartphones will be provided to the 
clinical site with the TatchSleep Pro companion application pre-loaded. Study staff will be 
trained on the use and functionalities of TatchSleep Pro and the companion application 
prior to enrollment. 
 

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TatchSleep Pro kits will be stored at room temperature at the clinical site in a secured, 
limited access location, under the supervision of the Investigator or designee. 
The Investigator or designee will be responsible for taking an inventory of each shipment 
of TatchSleep Pro kits received and comparing it with the accompanying shipping invoice 
to confirm accuracy of the shipment and its contents. All used and unused TatchSleep Pro 
wearable sensors will be retained at the site. After full device accountability and 
reconciliation, the Investigator will return the used and unused kits to the Sponsor or its 
designee. Disposition and use of all TatchSleep Pro sensors should be documented, 
including any that are lost or damaged.  
 
11.3 TatchSleep Pro Associated Risks 
Per the FDA guidelines "Significant Risk and Nonsignificant Risk Medical Device Studies" 
[4] and based on 21 CFR 812.3(m), TatchSleep Pro qualifies as a Non-Significant Risk 
device since TatchSleep Pro: 
• Is not intended as an implant and does not present a potential for serious risk to 
the health, safety, or welfare of a subject; 
• Is not purported or represented to be for use supporting or sustaining human life 
and does not present a potential for serious risk to the health, safety, or welfare of 
a subject; 
• Is not for a use of substantial importance in diagnosing, curing, mitigating, or 
treating disease, or otherwise preventing impairment of human health and does 
not present a potential for serious risk to the health, safety, or welfare of a subject; 
or 
• Does not otherwise present a potential for serious risk to the health, safety, or 
welfare of a subject. 
 
Although there is minimal risk in using the TatchSleep Pro technology, patients may 
experience some slight discomfort wearing the TatchSleep Pro patches or the compatible 
pulse oximeter throughout the night. It is possible that patients with sensitive skin may 
experience mild skin irritation due to the patch adhesive. A similar skin irritation risk exists 
in the PSG test. Patients will be clearly instructed that they are allowed to remove the 
TatchSleep Pro patches, pulse oximeter, or the adhesive from the PSG study if they 
experience skin irritation or significant discomfort at any point. A previous analysis showed 
no adverse events amongst a cohort of 19 patients undergoing full night tests wearing the 
TatchSleep Pro patches. 
 
There is also a risk that the technology will not function as anticipated causing partial 
recording of the study night which might make data unusable. It will be explained to the 
participants that these technologies are still evolving, and they may experience glitches or 
malfunctions during the study. 
 
12. Adverse Events 
 
12.1 Adverse Event Definition 

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An adverse event (AE) is any symptom, sign, illness or experience that develops or 
worsens in severity during the course of the study. Intercurrent illnesses or injuries should 
be regarded as adverse events.  Abnormal results of diagnostic procedures are considered 
to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
 
An adverse device effect (ADE) is any reported AE that is considered device-related. 
 
12.2 Severity 
Adverse events will be classified by the investigator as mild, moderate, severe, life 
threatening, or fatal. 
 
When the severity of the AE increases over time, the change in severity will be recorded 
in the source documents as a new AE and the original AE will stop when the new AE starts. 
The Principal Investigator or the delegated person must record all AEs that occur during 
the study from the time of TatchSleep Pro placement until study completion or Early 
Termination, regardless of their relationship to study device or procedure. 
 
The Principal Investigator will evaluate the severity of AEs and determine their relationship 
to the study device or procedures. Any action or procedure followed by the patient or 
clinical staff to alleviate the AE will be documented regardless of who recommended such 
action or procedure. The clinical course of each event will be followed until resolution, 
stabilization, or clinically significant improvement that requires no further follow-ups in the 
opinion of the Investigator. 
 
12.3 Serious Adverse Events (SAE) and Unanticipated Adverse Device Effect (UADE) 
A serious adverse event (SAE) may or may not be considered related to the device and 
may be described as follows: 
• Death due to any cause  
• Life-threatening condition 
• Persistent or significant disability/incapacity 
• Any event resulting in hospitalization or prolonged hospitalization 
• Congenital abnormality 
• Is considered an important medical event by the Investigator or Sponsor 
 
A UADE is any serious adverse effect on health or safety, or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or application (including a supplementary plan or application), or any other unanticipated 

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serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects. 
 
 
12.4 Event Reporting 
All AEs will be recorded on the CRF by the Investigator or designee regardless of their 
relationship to the study device. SAEs and ADEs should be reported to the Sponsor within 
24 hours of knowledge of the event using the SAE/ADE Report Form provided by the 
Sponsor.  UADEs must be reported by the clinical investigator to the sponsor and the 
reviewing IRB, no event later than 10 working days after the investigator first learns of the 
event.  Sponsors must immediately conduct an evaluation of a UADE and must report the 
results of the evaluation to FDA, all reviewing IRBs, and participating investigators within 
10 working days after the sponsor first receives notice of the effect. 
 
13. Early Termination 
 
Study patients may decide to withdraw from the research study without any penalty and 
for any reason. Study patients may be considered withdrawn if they state an intention to 
withdraw or fail to participate. Although patients are not required to provide a reason for 
withdrawal, they will be asked by research staff about their decision. The Investigator also 
reserves the right to remove a study participant from the study at any time for any reason 
(e.g. non-compliance with study requirements, safety reasons). 
Study patients may also withdraw permission for the use and disclosure of any of their 
protected information for research but must do so in writing to the Principal Investigator.  
 
14. Data Analysis 
14.1 General Considerations 
Summary statistics for continuous variables will include the mean, standard deviation, 
median, and range. Categorical variables will be presented as counts and percentages. 
All confidence intervals provided will be calculated at the 95% confidence level, unless 
otherwise noted. All null hypotheses will be tested against two-sided alternatives at the 5% 
significance level, unless otherwise noted. Any other details not included in this protocol 
will be included in the Statistical Analysis Plan. 
 
14.2 Analysis Population  
Subjects with less than 4 hours of valid oximetry and flow data in either the PSG or 
TatchSleep Pro recording (taking "movement" and "artifact" annotations into account 
following scoring – see protocol sections 8.4 and 8.5) will not be included in the analysis 
population [3].  All other participants who are enrolled, meet all the inclusion criteria and 
none of the exclusion criteria, and whose sleep studies have >4 hours of recorded and 
valid data from both systems will be included in the Analysis Population [3].   

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14.3 Safety Population  
All participants who meet all of the inclusion criteria and none of the exclusion criteria and 
participated in the sleep study will be included in the Safety Population.  
 
14.4 Demographics 
Demographic and baseline characteristics (age, sex, BMI, skin tone and presence of body 
hair) will be tabulated.  The flowing table shows the measurement units/scale and 
approximate expected ranges for these characteristics: 
 
Characteristic 
Units or Scale 
Expected Range 
Sex 
-- 
Male, Female 
Age 
Years 
21-75 
BMI 
kg / m2 
23-40 
Skin Tone 
Fitzpatrick Scale 
II - VI 
Body Hair 
-- 
No visible hair, moderate 
hair (≤10 follicles/cm2), 
heavy hair (>10 follicles/cm2) 
 
 
14.5 Primary Outcome Evaluation 
The first co-primary performance objective is to demonstrate that the correlation between 
PSG and TATCH AHI is greater than the performance goal (PG) using a significance level 
of 0.025. 
The hypotheses to be tested are: 
𝐻0: 𝜌 ≤𝑃𝐺    versus 
𝐻𝑎: 𝜌 > 𝑃𝐺  
 
where ρ is the Pearson correlation between PSG and TatchSleep Pro AHI and 𝑃𝐺 is the 
performance goal. The performance goal is set to be 0.862, the lower 95% confidence limit 
for the correlation of RDI and AHI between PSG and Peripheral Arterial Tonometry (PAT) 
as calculated in a meta-analysis of 12 studies [5]. Fisher's transformation and one-sided 
Z-test will be used to test the hypotheses with a significance level of 0.025. 
 
The second co-primary performance objective is to demonstrate that the 95% limits of 
agreement between PSG and TATCH AHI within the performance goals (PGL and PGU) 
using a significance level of 0.05. 
The hypotheses to be tested are: 
𝐻01: 𝑈𝐿≥𝑃𝐺𝑈
vs.
𝐻𝑎1: 𝑈𝐿< 𝑃𝐺𝑈 
𝐻02: 𝐿𝐿≤𝑃𝐺𝐿
vs.
𝐻𝑎2: 𝐿𝐿> 𝑃𝐺𝐿 
 
where 𝑈𝐿 and 𝐿𝐿 are the upper and lower 95% limits of agreement between PSG and TATCH 

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AHI. The performance goals 𝑃𝐺𝑈 and 𝑃𝐺𝐿 are set to be the upper and lower limits, 
respectively, of the 95% confidence interval in a meta-analysis of 7 FDA approved devices 
(28.4 and -30.6). The full meta-analysis is detailed in Appendix 1.  A Wald Z-test will be used 
to test the hypotheses with a significance level of 0.05. All three null hypotheses need to be 
rejected in order for the trial to be successful. 
 
 
14.6 Secondary Outcomes Evaluation 
• A weighted Deming regression of TatchSleep Pro AHI on PSG AHI will be run. 95% 
confidence intervals for the slope and intercept will be obtained.  
• The inter-rater reliability, measured as the intra-class correlation (ICC) of AHI readings 
and its 95% confidence interval will be calculated. 
• Agreement between TatchSleep Pro and PSG apnea classification (mild, moderate, and 
severe, according to the American Academy of Sleep Medicine definition) will be 
calculated. 
• Bland-Altman plots and estimation of the 95% limits of agreement between 
TatchSleep Pro and PSG AHI for each position (supine vs. non-supine). 
 
 
14.7 Primary Safety Evaluation 
The primary safety endpoints are the incidence of AEs and SAEs related to the device 
throughout the study period. 
 
 
14.8 Sample Size 
The correlation of PSG and TATCH AHI data on 19 subjects previously rated by a single 
rater was estimated to be 0.98.  We calculated the probability of rejecting the null 
hypothesis when the true correlation is 0.98 using the Pearson's Correlation Tests 
Procedure of NCSS Power Analysis Statistical Software, Version 20 (PASS 20, [6]). A 
sample size of 46 subjects yields a power of 99.99%. 
 
The ICC of PSG and TATCH AHI data on 19 subjects was 0.95, we use this as an estimate 
for the sample size calculation. A sample of 46 subjects yields a 95% margin of error for 
the ICC of 5%, assuming a true ICC value of 0.95, using the Confidence Intervals for 
Intraclass Correlation Procedure of NCSS Power Analysis Statistical Software, Version 20 
(PASS 20, [6]). 
 
The upper and lower limits of agreement of PSG and TATCH AHI data on 19 subjects 
previously rated by a single rater was estimated to be 10.6 and -3.2, with a standard deviation 
of 3.5. Because the standard deviation increases with increasing AHI, and the previous AHI 
range was 0 to 30 events/hour, we conservatively assumed a standard deviation of 7.0 
events/hour, yielding a standard deviation for the LOA of √3𝜎= 12.1, as described in Bland-

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Altman. We calculated the power to reject the null hypothesis using the One Sample T-Tests 
Procedure of NCSS Power Analysis Statistical Software, Version 20 (PASS 20, [6]). A sample 
size of 46 subjects yields an 99.9% probability of rejecting the null hypothesis for both the 
upper and lower LOAs. 
 
A total sample size of 46 subjects yields sufficient power for the primary objective and 
allows for sufficient precision in estimating the inter-rater reliability, which is a secondary 
objective; approximately 50 subjects will be enrolled to allow for a 5-8% drop-out rate. 
 
 
15. Study Administration 
 
15.1 GCP Statement 
This study is to be performed in accordance with the protocol, the Declaration of Helsinki, 
the International Conference on Harmonisation (ICH), Guideline for Good Clinical Practice 
(GCP), and all applicable local regulatory requirements. 
 
15.2 Informed Consent 
The Sponsor will provide a sample patient ICF for modification, as appropriate, by the 
Investigator. The ICF must include all elements required by ICH and GCP and must adhere 
to the IRB requirements and the ethical principles that have their origin in the Declaration 
of Helsinki. 
The informed consent process will take place up to 7 days prior to the patient's scheduled 
overnight PSG. The Investigator or designee will conduct the informed consent process 
and only patients willing to sign and personally date the ICF agreeing to participate in the 
study will be enrolled. A copy of the signed and dated ICF will be provided to the patient, 
while the signed original ICF will be part of the Investigator site files, per local 
requirements. 
The ICF will be revised whenever new information or a protocol amendment becomes 
available that may be relevant to the patient's consent. All ICF versions must be submitted 
and approved by the IRB in advance of use. Approved ICFs should be forwarded to the 
Sponsor. When a new ICF is approved by the IRB all subjects enrolled in the study at the 
time of the approval will be re-consented. Only the most up to date IRB-approved ICF must 
be used to consent new patients. 
 
15.3 Institutional Review Board 
The final study protocol, including the final version of the ICF, must be approved in writing 
by an IRB. The Principal Investigator must submit written approval from the IRB to the 
Sponsor before he or she can enroll any patient into the study. 

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The Principal Investigator is responsible for informing the IRB of any amendment to the 
protocol. In addition, the IRB must approve all advertising used to recruit patients for the 
study and all Sleep Questionnaires. The protocol must be re-approved by the IRB annually 
or as required by the IRB, regulations, and guidelines. 
 
15.4 Sponsor Monitoring 
Before the first patient at each site signs consent to participate in the study, a 
representative of the Sponsor will visit the study site to: 
• Determine the adequacy of the facilities 
• Discuss with the Investigator(s) (and other personnel involved with the study) their 
responsibilities with regard to the protocol and the responsibilities of the Sponsor 
• Confirm that the Investigator(s) (and other personnel involved with the study) have 
not invoked sanctions or demonstrated any scientific misconduct or fraud 
During the conduct of the study, a representative of the Sponsor will have regular contact 
with the clinical trial sites, and monitor (in-person or remote) the clinical sites to: 
• Provide information and support the Investigators 
• Confirm that the facilities remain acceptable 
• Confirm that the study team is adhering to the protocol, data are being accurately 
recorded, and the device is being properly maintained and accountability records 
are current 
• Perform source data verification with access to all original clinical records for each 
patient 
 
15.5 Documentation and Intended Use of Data 
Tatch will receive only de-identified data from the study site. All study data from the  CRFs 
will be kept at the study site in a secured location. During the course of the study and 
during the analysis phase all data will be kept secured with Tatch, Inc. Findings and 
process related information, including study design and analysis will appear in a final report 
issued to the Sponsor and will not include any identifiable information on individual 
participants. The analysis may be submitted to relevant regulatory bodies to support 
submissions for regulatory clearance.  The analysis may be published in a white paper 
available to the general public and a peer reviewed publication and will include only de-
identified, aggregated level data. 
 
15.6 Record Retention 
All correspondence related to this clinical study should be kept in appropriate study files. 
Records of patients, source documents, device inventory, IRB, and Sponsor 
correspondence pertaining to this study must be kept on file. All records should be retained 
for a period of time equivalent to the design and expected life of the device, but in no case 

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PROTOCOL NUMBER: TCH-110  
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less than 2 years after the date on which the investigation is terminated or completed, or 
the date that the records are no longer required for purposes of a marketing submission. 
There may be other circumstances for which the Sponsor is required to maintain study 
records and, therefore, the Sponsor should be contacted prior to removing or relocating 
study records for any reason. 
 
16. References 
 
1. Peppard, Paul E., et al. "Increased prevalence of sleep-disordered breathing in 
adults." American journal of epidemiology 177.9 (2013): 1006-1014. 
2. De Cruz, Sharon, Michael R. Littner, and Michelle R. Zeidler. "Home Sleep Testing 
for the Diagnosis of Obstructive Sleep Apnea—Indications and Limitations." 
Seminars in respiratory and critical care medicine. Vol. 35. No. 05. Thieme Medical 
Publishers, 2014. 
3. Kapur, Vishesh K., 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, 13(3): 479-504. 
4. https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/significant-risk-and-nonsignificant-risk-medical-device-studies 
5. Yalamanchali S, et al, “Diagnosis of obstructive sleep apnea by peripheral arterial 
tonometry: meta-analysis”, JAMA Otolaryngology – Head & Neck Surgery, 2013, 
139(12): 1343-1350 
6. PASS 2020 Power Analysis and Sample Size Software (2020). NCSS, LLC. 
Kaysville, Utah, USA, ncss.com/software/pass. 
 
 

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Appendix 1 – Bland-Altman LOA Meta-Analysis 
A meta-analysis was undertaken in support of developing a performance goal for the primary 
effectiveness endpoint of the Bland-Altman 95% limits of agreement (LOA). A total of 7 studies 
of 7 different FDA approved devices were chosen that used manual scoring of AHI in concurrent 
laboratory studies. A summary of the 7 devices used in the meta-analysis is provided in Table 1. 
 
Table 1:  Summary of Predicate HST Studies  
Publication  
Device 
Reference N 
Lower 
95% 
LOA 
Upper 
95% 
LOA 
SD 
Westbrook et al., 
2005 
ARES 
Figure 6 
187 
-30.5 
26.7 
14.3 
Massie et al., 2018 
NightOwl 
Figure 3 
101 
-38.9 
39.6 
20.0 
Weiman et al., 2013 
WatchPAT200 Figure 2 
28 
-13.6 
19.5 
8.4 
Erman et al., 2007 
ApneaLink 
Figure 3 
59 
-21.3 
18.0 
10.0 
Xu et al., 2017 
Nox-T3home  
Figure 1A 
77 
-26.6 
17.4 
11.0 
Santos-Silva et al. 
2009 
Stardust 
Figure 3D 
80 
-24.9 
22.8 
12.2 
Nilius et al. 2017 
Alice 
Figure 3A 
85 
-13.5 
10.3 
5.9 
 
 
 
A random effects model was utilized to generate an estimate of the average lower and upper 
LOA across the 7 studies.  The random effects estimate was calculated using the Metafor  [1] 
(Meta-Analysis Package for R) package.  Restricted maximum likelihood was used to estimate 
the mean success rate and the variability among studies.  The mean lower LOA and 
confidence intervals for each of the 7 studies, as well as the random effects (RE) summary 
results are presented in Figure 1; results for the upper LOA are presented in Figure 2.  The 
random-effects model estimates a weighted least squares mean upper limit of 21.8 with a 95% 
confidence interval of 15.1 to 28.4; the random-effects model estimates a weighted least 
squares mean lower limit of -24.0 with a 95% confidence interval of -30.6 to -17.4.  From this 
analysis, it is reasonable to use 28.4 for the upper limit performance goal and -30.6 as the 
lower limit performance goal for the LOA primary effectiveness endpoint analysis in our study. 
 
 
 

28 
 
 
 
PROTOCOL NUMBER: TCH-110  
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Figure 1:  Lower 95% LOAs for each study and 95% confidence intervals.   
 
 
 
RE Model
-50
-40
-30
-20
-10
0
Observed Outcome
Alice
Stardust
Nox-T3
ApneaLink
WatchPAT 200
NightOwl
ARES
-13.50 [-15.67, -11.33]
-24.90 [-29.53, -20.27]
-26.60 [-30.86, -22.34]
-21.30 [-25.72, -16.88]
-13.60 [-18.99,  -8.21]
-38.90 [-45.66, -32.14]
-30.50 [-34.05, -26.95]
-24.01 [-30.61, -17.41]

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PROTOCOL NUMBER: TCH-110  
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Figure 2:  Upper 95% LOAs for each study and 95% confidence intervals.   
 
 
 
RE Model
0
10
20
30
40
50
Observed Outcome
Alice
Stardust
Nox-T3
ApneaLink
WatchPAT 200
NightOwl
ARES
10.30 [ 8.13, 12.47]
22.80 [18.17, 27.43]
17.40 [13.14, 21.66]
18.00 [13.58, 22.42]
19.50 [14.11, 24.89]
39.60 [32.84, 46.36]
26.70 [23.15, 30.25]
21.78 [15.12, 28.45]

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References: 
1. Viechtbauer, W. (2010).  Conducting meta-analyses in R with the metaphor package.  
Journal of Statistical Software, 36(3), 1-48.  http://www.jstatsoft.org/v36/i03/. 
2. Westbrook PR, Levendowski DJ, Cvetinovic M, Zavora T, Velimirovic V, Henninger D, 
Nicholson D. Description and validation of the apnea risk evaluation system: a novel 
method to diagnose sleep apnea-hypopnea in the home. Chest. 2005 Oct;128(4):2166-
75. doi: 10.1378/chest.128.4.2166. PMID: 16236870. 
3. Massie F, Mendes de Almeida D, Dreesen P, Thijs I, Vranken J, Klerkx S. An evaluation 
of the NightOwl home sleep apnea testing system. J Clin Sleep Med. 2018 14(10): 1791-
1796. 
4. Weimin L, Rongguang W, Dongyan H, Xiaoli L, Wei J, Shiming Y. Assessment of a 
portable monitoring device WatchPAT 200 in the diagnosis of obstructive sleep apnea. 
Eur Arch Otorhinolaryngol. 2013 270:3099-3105. 
5. Erman MK, Stewart D, Einhorn D, Gordon N, Casal E. Validation of the ApneaLink for the 
screening of sleep apnea: a novel and simple single-channel recording device. J Clin 
Sleep Med. 2007 Jun 15;3(4):387-92. PMID: 17694728; PMCID: PMC1978315. 
6. Xu L, Han F, Keenan BT, Kneeland-Szanto E, Yan H, Dong X, Chang Y, Zhao L, Zhang 
X, Li J, Pack AI, Kuna ST. Validation of the Nox-T3 Portable Monitor for Diagnosis of 
Obstructive Sleep Apnea in Chinese Adults. J Clin Sleep Med. 2017 May 15;13(5):675-
683. doi: 10.5664/jcsm.6582. PMID: 28356181; PMCID: PMC5406954. 
7. Santos-Silva R, Sartori E, Truksinas V, Truksinas E, Alonso F, Tufik S, Bittencourt L. 
Validation of a portable monitoring system for the diagnosis of obstructive sleep apnea 
syndrome. SLEEP 2009: 32(5): 629-636. 
8. Nilius G, Domanski U, Schroeder M, Franke K-J, Hogrebe A, Margarit L, Stoica M, 
d’Ortho M-P. A randomized controlled trial to validate the Alice PDX ambulatory device. 
Nature and Science of Sleep 2017 9: 171-180.