Diagnostic Validation of the DreamKit Device Against Polysomnography
Phase: NA
Conditions: Sleep Apnea, Obstructive, Sleep Apnea, Central
Sponsor: Philips Clinical & Medical Affairs Global

Clinical Investigation Protocol ICH E6 Aligned 
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SRC_SLE_Sparkle_P
SG_2020_10908 
Document title: 
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Modified: 
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Clinical Investigation Protocol ICH E6 Aligned 
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Status: 
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Diagnostic validation of the DreamKit device against polysomnography 
Protocol ID: SRC_SLE_Sparkle_PSG_2020_10908 
Version 5 
26th of July, 2021 
Final
Clinical Study Sponsor: 
Philips Respironics Inc., a Philips company (“Philips 
Respironics”) 
1740 Golden Mile Highway 
Monroeville PA 15146, USA 
Sponsor Lead: 
Bill Hardy;  Sr. Scientific Writer 
Study Managed By: 
Philips Clinical & Medical Affairs 
1740 Golden Mile Highway 
Monroeville, PA 15146 
Clinical Study Manager: 
Krager Vaughn 
Biostatistician: 
Jeff Jasko 
Database Manager: 
Lindsey Heffernan 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
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SG_2020_10908 
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Version: 
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Status: 
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Clinical Study Site 1: 
Sleep Disorder Center of Alabama 
Site Principal Investigator: William G. Adams, Jr., MD 
790 Montclair Road, Suite 200 
Birmingham, AL 35213  
 
Clinical Study Site 2: 
Clayton Sleep Institute  
Site Principal Investigator: Joseph M. Ojile, MD   
2531 South Big Bend Boulevard 
St. Louis MO 63143 
 
Clinical Study Site 3: 
Florida Lung and Sleep Associates 
Site Principal Investigator: Alaa El-Gendy, MD 
2625 Lee Boulevard, Suite 100 
Lehigh Acres, FL 33974 
 
Clinical Study Site 4: 
Delta Waves, Inc. 
Site Principal Investigator: H Samuel Scheuller, MD 
5835 Lehman Drive, Suite 101 
Colorado Springs, CO 80918 
 
Clinical Study Site 5: 
Pulmonary and Critical Care Associates of Baltimore, 
P.A. 
Site Principal Investigator: Alan Schwartz, MD 
501 Fairmont Ave, Suite 103 
Towson, MD 21286 
 
Clinical Study Site 6: 
Bogan Sleep Consultants 
 
Site Principal Investigator: Richard Bogan, MD 
 
1333 Taylor Street, Suite 6B 
 
Columbia, SC 29201 
 
 
 
 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
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SG_2020_10908 
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Version: 
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Clinical Study Site 7 
 
 
Berks Schuylkill Respiratory Specialists 
Site Principal Investigator: Daron Kahn, MD 
2608 Keiser Blvd 
Wyomissing, PA 19610 
 
 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
Document 
ID: 
SRC_SLE_Sparkle_P
SG_2020_10908 
Document title: 
Classification: 
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Modified: 
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Clinical Investigation Protocol ICH E6 Aligned 
Version: 
5 
User Tool ID:  
16.2.6UserTool0004 
Page: 
4 
Status: 
Final 
User Tool Version Date 
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VERSION HISTORY 
Version 
No.  
Amendment 
No.  
Version 
Date 
Summary of Changes  
Rationale 
1.0 
N/A 
3 Nov 2020 Initial release 
N/A 
2 
1 
2 Dec 2020 
Clarified purpose of actigraphy 
Removed waiver of consent 
request. 
IRB request 
3 
2 
15 Jan 
2020 
Clarification of AE surveillance 
Unnecessary for 
low-risk 
procedures 
4 
3 
8 Jun 2021 
Increased sample size 
Needed to allow 
for additional 
screening 
5 
4 
26Jul2021 
Addition of another clinical site 
and changes in Philips’s 
staffing 
Needed for study 
completion 
 
 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
Document 
ID: 
SRC_SLE_Sparkle_P
SG_2020_10908 
Document title: 
Classification: 
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Clinical Investigation Protocol ICH E6 Aligned 
Version: 
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Status: 
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ABBREVIATIONS 
Abbreviation 
Definition 
AASM 
American Academy of Sleep Medicine 
AE 
Adverse event 
AHI 
Apnea-hypopnea index 
CAI 
Central apnea index 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CRF 
Case report form 
CSA 
Central sleep apnea 
EEG 
Electroencephalography 
EMG 
Electromyography 
EOG 
Electrooculography 
FDA 
Food and Drug Administration 
HSAT 
Home sleep apnea test 
ICC 
Intraclass correlation coefficient 
ICH GCP 
International Conference on Harmonization Good Clinical Practice 
IRB 
Institutional review board 
ODI 
Oxygen desaturation index 
OSA 
Obstructive sleep apnea 
PAP 
Positive airway pressure 
PARE 
Plethysmography-acquired respiratory effort 
PSG 
Polysomnography 
REI 
Respiratory event index 
RIP 
Respiratory inductance plethysmography 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
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SG_2020_10908 
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Version: 
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Status: 
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RPSGT 
Registered polysomnographic technologist 
SADE 
Serious adverse device event 
SAE 
Serious adverse event 
SDB 
Sleep-disordered breathing 
SpO2 
Oxygen saturation 
STARD 
Standards for Reporting Diagnostic Accuracy  
UADE 
Unanticipated adverse device event 
UP 
Unanticipated problem 
US 
United States 
 
 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
Document 
ID: 
SRC_SLE_Sparkle_P
SG_2020_10908 
Document title: 
Classification: 
Confidential 
Modified: 
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Clinical Investigation Protocol ICH E6 Aligned 
Version: 
5 
User Tool ID:  
16.2.6UserTool0004 
Page: 
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Status: 
Final 
User Tool Version Date 
5June2019 
 
TABLE OF CONTENTS 
VERSION HISTORY ................................................................................................................... 4 
SPONSOR SIGN-OFF ................................................................................................................ 5 
ABBREVIATIONS ...................................................................................................................... 6 
TABLE OF CONTENTS ............................................................................................................. 8 
1. 
STATEMENT OF COMPLIANCE .................................................................................. 11 
2. 
PROTOCOL SUMMARY .............................................................................................. 12 
2.1. 
Synopsis ............................................................................................................ 12 
2.2. 
Schedule of Activities ......................................................................................... 15 
3. 
INTRODUCTION ........................................................................................................... 16 
3.1. 
Study Rationale ................................................................................................. 16 
3.2. 
Background ....................................................................................................... 16 
4. 
OBJECTIVES ............................................................................................................... 17 
4.1. 
Endpoints .......................................................................................................... 17 
4.2. 
Hypotheses........................................................................................................ 17 
4.3. 
Exploratory Analyses ......................................................................................... 17 
4.4. 
Claims and Intended Performance ..................................................................... 17 
4.5. 
Considerations regarding study endpoints ......................................................... 18 
4.5.1. Rationale for the selection of endpoints .................................................. 18 
4.5.2. Rationale for the identification of performance thresholds ...................... 18 
4.6. 
Inclusion of Actigraphy ....................................................................................... 19 
5. 
STUDY DESIGN ........................................................................................................... 20 
5.1. 
Overall Design ................................................................................................... 20 
5.2. 
Scientific Rationale for Study Design ................................................................. 20 
5.3. 
Justification of Treatment Regimen and Duration .............................................. 20 
5.4. 
Measures to Minimize Bias ................................................................................ 20 
5.5. 
End of Study Definition ...................................................................................... 20 
6. 
STUDY PARTICIPANTS ............................................................................................... 21 
6.1. 
Inclusion Criteria ................................................................................................ 21 
6.2. 
Exclusion Criteria ............................................................................................... 21 
6.3. 
Enrollment ......................................................................................................... 22 
6.4. 
Screen Failures ................................................................................................. 22 
6.5. 
Strategies for Recruitment and Retention .......................................................... 22 
7. 
STUDY INTERVENTION .............................................................................................. 24 
7.1. 
Acquisition and Accountability............................................................................ 24 
7.2. 
Formulation, Appearance, Packaging, and Labeling .......................................... 24 

 
 
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7.3. 
Product Storage and Stability ............................................................................ 24 
7.4. 
Preparation ........................................................................................................ 24 
8. 
STUDY PROCEDURES & EVALUATIONS .................................................................. 25 
8.1. 
Efficacy Assessments ........................................................................................ 25 
8.1.1. Phone screening .................................................................................... 25 
8.1.2. Visit 1: Office visit for enrollment ............................................................ 25 
8.1.3. Visit 2: Overnight laboratory visit for testing ............................................ 25 
8.1.4. Adverse event monitoring ....................................................................... 27 
8.1.5. Data processing and scoring .................................................................. 28 
8.1.6. Signal quality and other feedback to sites .............................................. 28 
8.1.7. Compensation ........................................................................................ 29 
8.2. 
Safety Assessments .......................................................................................... 29 
9. 
Discontinuation/Withdrawal from the Study ............................................................. 30 
9.1. 
Discontinuations and Withdrawals ..................................................................... 30 
9.2. 
Lost to Follow-Up ............................................................................................... 30 
9.3. 
Impact on Recruitment ....................................................................................... 30 
10. 
RISK/BENEFIT ASSESSMENT .................................................................................... 31 
10.1. 
Known potential risks ......................................................................................... 31 
10.2. 
Known potential benefits .................................................................................... 31 
10.3. 
Assessment of Potential Risks and Benefits ...................................................... 31 
11. 
SAFETY MONITORING ................................................................................................ 33 
11.1. 
Adverse Events and Serious Adverse Events .................................................... 33 
11.1.1. Definition of Adverse Events .................................................................. 33 
11.1.2. Definition of Serious Adverse Events ..................................................... 33 
11.2. 
Unanticipated Adverse Device Event ................................................................. 33 
11.3. 
Classification of an Adverse Event or Adverse Device Event ............................. 33 
11.3.1. Severity of Event .................................................................................... 33 
11.3.2. Relationship to the Study or Device........................................................ 34 
11.3.3. Expectedness ........................................................................................ 35 
11.4. 
Adverse Event Assessment and Follow-Up ....................................................... 35 
11.5. 
Serious Adverse Event or Serious Adverse Device Event Reporting ................. 35 
11.6. 
Device Deficiency .............................................................................................. 35 
11.7. 
Unanticipated Problems ..................................................................................... 36 
11.7.1. Definition of Unanticipated Problems ...................................................... 36 
11.7.2. Unanticipated Problem Reporting ........................................................... 36 
12. 
STATISTICAL CONSIDERATIONS .............................................................................. 37 
12.1. 
Statistical Analyses ............................................................................................ 37 

 
 
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Version: 
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Status: 
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User Tool Version Date 
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12.1.1. Sample Size Determination .................................................................... 37 
12.1.2. General Considerations .......................................................................... 37 
12.1.3. Participant Disposition ............................................................................ 37 
12.1.4. Demographics and Baseline Characteristics .......................................... 37 
12.1.5. Analysis of the Primary Endpoint ............................................................ 38 
12.1.6. Analysis of the Secondary Endpoint ....................................................... 38 
12.1.7. Adjustment for Multiplicity ....................................................................... 38 
12.1.8. Exploratory Analyses ............................................................................. 38 
12.2. 
Exploratory Analyses of Actigraphy Data ........................................................... 39 
12.3. 
Safety Analyses ................................................................................................. 39 
12.4. 
Planned Interim Analyses .................................................................................. 39 
12.5. 
Missing Unused and Spurious Data ................................................................... 39 
12.6. 
Deviations from the Statistical Analysis Plan...................................................... 39 
13. 
OPERATIONAL CONSIDERATIONS ........................................................................... 40 
13.1. 
Regulatory and Ethical Considerations .............................................................. 40 
13.1.1. Informed Consent Process ..................................................................... 40 
13.1.2. Consent Procedures and Documentation ............................................... 40 
13.1.3. Study Discontinuation and Closure......................................................... 40 
13.1.4. Confidentiality and Privacy ..................................................................... 41 
13.2. 
Future Use of Stored Specimens and Data ........................................................ 41 
13.3. 
Safety Oversight ................................................................................................ 42 
13.4. 
Clinical Monitoring ............................................................................................. 42 
13.5. 
Quality Assurance and Quality Control .............................................................. 42 
13.5.1. Data Handling and Record Keeping ....................................................... 42 
13.5.2. Data Collection and Management Responsibilities ................................. 42 
13.6. 
Study Records Retention ................................................................................... 43 
13.7. 
Protocol Deviations ............................................................................................ 43 
13.8. 
Publication and Data Sharing Policy .................................................................. 43 
13.9. 
Registration ....................................................................................................... 43 
13.10. Conflict of Interest Policy ................................................................................... 44 
14. 
REFERENCES .............................................................................................................. 45 
15. 
APPENDICES ............................................................................................................... 47 
16. 
INVESTIGATOR’S STATEMENT ................................................................................. 48 
 
 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
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Document title: 
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Clinical Investigation Protocol ICH E6 Aligned 
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Status: 
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1. 
STATEMENT OF COMPLIANCE 
This study will be carried out in accordance with International Conference on Harmonization Good Clinical 
Practice (ICH GCP) and the following:  
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 
CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
The protocol, informed consent form, recruitment materials, and all participant materials will be submitted 
to the Institutional Review Board (IRB) for review and approval.  Approval of both the protocol and the 
consent form must be obtained before any participant is enrolled.  Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented in the study.  In addition, all 
changes to the consent form will be IRB-approved; a determination will be made regarding whether a new 
consent needs to be obtained from participants who provided consent using a previously approved consent 
form. 
 
 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
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SG_2020_10908 
Document title: 
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Clinical Investigation Protocol ICH E6 Aligned 
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Status: 
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User Tool Version Date 
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2. 
PROTOCOL SUMMARY 
2.1. 
Synopsis 
Study Title & ID: 
Diagnostic validation of the DreamKit device against polysomnography 
SRC_SLE_Sparkle_PSG_2020_10908 
Project Name: 
Sparkle 
Study Design: 
Multi-center validation study. 
Objective: 
The objective of this study is to demonstrate the diagnostic efficacy of 
the DreamKit device against the gold-standard comparator, 
polysomnography (PSG), amongst a sample of n=200 participants with 
and without sleep-disordered breathing (SDB). 
Endpoints: 
Primary Endpoint: The intraclass correlation coefficient (ICC) for 
absolute agreement between the PSG- apnea hypopnea index (AHI) 
and DreamKit-AHI. 
Secondary Endpoint: The ICC for absolute agreement between the 
PSG- central apnea index (CAI) and DreamKit-CAI. 
Hypotheses: 
Hypothesis 1 (Primary): We hypothesize that the lower-bound of the ICC 
95% confidence interval (CI) between the PSG-AHI and DreamKit-AHI 
will be ≥0.75, indicating good reliability. 
Hypothesis 2 (Secondary): We hypothesize that the lower-bound of the 
ICC 95% CI between the PSG-CAI and DreamKit-CAI will be ≥0.50, 
indicating moderate reliability. 
Study Sample: 
Up to n=280 participants will be enrolled, in order for n=200 participants 
to complete the study with valid data. 
Inclusion Criteria: 
• 
INCL1: Aged ≥18 years; 
• 
INCL2: Fluent in English; 
• 
INCL 3: Able to provide informed consent. 

 
 
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Exclusion Criteria:  
• 
EXCL 1: Self-reported habitual sleep duration of <4 hours/night on 
average (“How many hours sleep do you usually get per night?”); 
• 
EXCL 2: Circadian phase disorder, shift work, or any other 
issue/condition that would, in the opinion of the site investigator, 
reduce the likelihood of obtaining at least four hours of sleep 
during the overnight study; 
• 
EXCL 3: History of allergic reactions to medical adhesives; 
• 
EXCL 4: Skin rash or other dermatological condition that would 
impact correct placement of the DreamKit device and/or PSG 
sensors, and/or would be exacerbated by the presence of the 
device or sensors; 
• 
EXCL 5: Presence of a pacemaker; 
• 
EXCL 6: Severe medical condition (controlled or uncontrolled) that 
would impede data collection in the opinion of the site investigator, 
including the requirement for oxygen therapy; 
• 
EXCL 7 [for those currently using overnight therapy]: Unwilling to 
withdraw from overnight therapy for a single night and/or clinically 
unsuitable to withdraw from overnight therapy in the opinion of the 
site investigator, with overnight therapy including but not limited to 
any form of positive airway pressure (PAP) or ventilation, oral 
device including mandibular advancement devices or mouthguard 
for bruxism, nasal dilator strips, and/or positional device; 
• 
EXCL 8 [for those currently using overnight therapy]: Considered 
by the site investigator to be at risk of an adverse event (AE) 
resulting from hypersomnolence the day after the overnight visit, 
such as a high-risk occupation including but not limited to a pilot 
or commercial driver; 
• 
EXCL 9: An employee, or family member of an employee, of a 
company that designs, sells, or manufactures sleep related 
products (including Philips). 

 
 
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Study Visits Summary 
& Duration: 
Visit 1: Consent, anthropometrics, vital signs, questionnaires. 
Visit 2: Overnight, attended PSG with simultaneous DreamKit recording. 
 
 

 
 
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3. 
INTRODUCTION 
3.1. 
Study Rationale  
The primary objective of this study is to assess the diagnostic performance of the DreamKit device against 
the gold-standard comparator, polysomnography (PSG), amongst a sample of n=200 participants with and 
without sleep-disordered breathing (SDB).  Data will be used as evidence to support the proposed intended 
use statement, described in Section 4.4 below. 
Please see ER2235417 (Clinical Strategy & Clinical Development Plan Document – Sparkle) for a 
comprehensive overview of the clinical development plan for this product.  This protocol has been designed 
to address Evidence ID 006 of ER2235417 (Version 2). 
3.2. 
Background 
Home sleep apnea test (HSAT) devices are increasingly used to diagnose obstructive sleep apnea (OSA).1  
Potential advantages of taking the diagnostic process from the hospital to the home include reduced cost; 
increased access; reduced wait times; higher patient turnover; increased patient comfort; and the collection 
of data that is more representative of a patient’s usual sleep.  Drawbacks of the HSAT model include the 
reduced number of signals compared with PSG; reduced patient/provider contact thereby limiting the 
opportunity for OSA education/support; and increased possibility of configuration error or signal loss 
leading to the requirement for further testing.1-3  Research has demonstrated that a lab-based diagnostic 
approach is not superior to a home-based approach in terms of self-reported daytime sleepiness, quality 
of life, blood pressure, and subsequent adherence to positive airway pressure (PAP) measured over four 
weeks.4  Development of a simpler HSAT device may be beneficial in terms of maximizing the collection of 
good quality signals, while also increasing ease of use and patient comfort.  The DreamKit device has been 
designed to meet these needs. 
The DreamKit is a single-use adhesive patch containing an accelerometer and pulse oximeter, linked to 
nasal pressure cannulae.  From these three sensors, the following signals can be monitored or derived: 
nasal airflow, blood oxygen saturation (SpO2), pulse rate, respiratory effort, sleep time, and head position.  
The adhesive patch containing the pulse oximeter is designed to be placed on the forehead, connected to 
adhesive nasal pressure cannulae placed over the nasal bridge and directly below the nostrils.  Data are 
stored in the flash memory on the device, and can be uploaded to a computer upon completion of the 
recording. 
 
 

 
 
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4. 
OBJECTIVES 
The objective of this study is to demonstrate the diagnostic efficacy of the DreamKit device against the 
gold-standard comparator, PSG, amongst a sample of n=200 participants with and without SDB. 
4.1. 
Endpoints 
Primary Endpoint: The intraclass correlation coefficient (ICC) for absolute agreement between the PSG-
apnea-hypopnea index (AHI) and DreamKit-AHI. 
Secondary Endpoint: The ICC for absolute agreement between the PSG-central apnea index (CAI) and 
DreamKit-CAI. 
4.2. 
Hypotheses 
Hypothesis 1 (Primary): We hypothesize that the lower-bound of the ICC 95% confidence interval (CI) 
between the PSG-AHI and DreamKit-AHI will be ≥0.75, indicating good reliability.5 
Hypothesis 2 (Secondary): We hypothesize that the lower-bound of the ICC 95% CI between the PSG-
CAI and DreamKit-CAI will be ≥0.50, indicating moderate reliability.5 
4.3. 
Exploratory Analyses 
Exploratory analyses will include investigating reliability of the 3% oxygen desaturation index (ODI3%), 
total respiratory events, total apneas, total hypopneas, total obstructive apneas, total central apneas, and 
total mixed apneas; agreement of the AHI categorized according to American Academy of Sleep Medicine 
AASM thresholds for mild/moderate/severe SDB; diagnostic performance metrics at clinically-relevant 
thresholds of the AHI, CAI, and ODI3%; event-level differentiation of events; and a comparison of signal 
quality between the DreamKit and PSG.  The primary and secondary analyses will adopt the AASM 
recommended criteria for identifying hypopneas; in exploratory analyses we will also investigate the impact 
of using the alternative criteria. 
4.4. 
Claims and Intended Performance  
The proposed intended use statement for DreamKit is as follows, with the parts relevant to this study bolded 
(wording may change before regulatory submission): 
The DreamKit device is a physiologic data recorder intended to collect and record data for use by 
clinical software used in polysomnography and sleep disorder studies for the diagnosis of sleep 
related breathing disorders.  The Plethysmography-Acquired Respiratory Effort (PARE) algorithm 
provides a respiratory effort signal acquired from the DreamKit photoplethysmography signal that 
correlates with traditional respiratory effort signals used in polysomnography.  The DreamKit with 
PARE provides the information required to detect apneas and hypopneas and classify these 

 
 
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We identified a performance target of ≥0.50 for the lower-bound of the 95% CI of the ICC for the CAI, 
representing moderate reliability.  In their recent 510(k) submission for the Nox Sleep System (K192469; 
November 13th, 2019), Nox Medical adopted the same analysis along with a target of 0.46, as has been 
reported elsewhere in the literature.7 
Neither the WatchPAT nor Nox Sleep System are the predicate device for DreamKit; however, they are 
comparable devices with similar intended use statements to the DreamKit, all of which claim to be a 
diagnostic aid for sleep disorders.  The Watch-PAT300 (Itamar Medical; Caesarea, Israel) is an FDA-
approved (K153070) HSAT device which uses finger peripheral arterial tonometry, heart rate, and oxygen 
saturation to identify respiratory events and estimate sleep staging in the compatible zzzPAT software.  
The Nox Sleep System (Nox Medical; Reykjavik, Iceland) is an FDA-approved (K192469) platform 
consisting of a HSAT device, PSG device, software, mobile platform, and accessories. 
4.6. 
Inclusion of Actigraphy 
For exploratory product development purposes, we will also collect data from a wrist actigraphy device 
(GENEActiv Original; Activinsights).  The actigraphy data will not contribute to any DreamKit analyses.  The 
presence of the actigraphy device is akin to a participant sleeping with a regular wristwatch, and will 
therefore not impact the data used for the DreamKit analyses. 
The safety or efficacy of the actigraphy device is not under investigation.  The use of these devices is to 
collect data for exploratory purposes. 
 
 

 
 
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5. 
STUDY DESIGN  
5.1. 
Overall Design 
This is a multi-center study performed for the purpose of diagnostic validation.  Up to n=280 participants 
will be enrolled, in order for n=200 participants to complete the study with evaluable data.  Completion of 
the protocol by an individual participant will require an office visit of approximately one hour followed by an 
overnight laboratory visit of approximately 12 hours, to take place within a six week period.  If convenient, 
the two visits may be combined.  Total enrollment duration for an individual participant will not exceed six 
weeks; it is estimated that the entire study duration will not exceed nine months. 
5.2. 
Scientific Rationale for Study Design 
The study has been designed to align with the Standards for Reporting Diagnostic Accuracy (STARD) 
statement.8 
5.3. 
Justification of Treatment Regimen and Duration 
No treatment will be implemented during this study. 
5.4. 
Measures to Minimize Bias 
This study is designed for the purpose of diagnostic validation, and therefore randomization and blinding 
will not take place. 
5.5. 
End of Study Definition 
The study will be considered complete when participants are no longer being examined or the last 
participant’s last study visit has occurred. 
A participant is considered to have completed the study if he or she has completed all phases of the study 
including the last visit or the last scheduled procedure shown in the Schedule of Activities. 
 
 

 
 
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6. 
STUDY PARTICIPANTS 
The COVID-19 pandemic is an ongoing and evolving situation.  Each site will implement screening 
procedures that align with their local state and federal guidelines.  These procedures are not listed as 
formal entry criteria. 
6.1. 
Inclusion Criteria 
Subjects must meet all of the following inclusion criteria: 
• 
INCL1: Aged ≥18 years; 
• 
INCL2: Fluent in English; 
• 
INCL 3: Able to provide informed consent. 
6.2. 
Exclusion Criteria 
Subjects shall be excluded if any of the following are present:  
• 
EXCL 1: Self-reported habitual sleep duration of <4 hours/night on average (“How many hours sleep 
do you usually get per night?”); 
• 
EXCL 2: Circadian phase disorder, shift work, or any other issue/condition that would, in the opinion 
of the site investigator, reduce the likelihood of obtaining at least four hours of sleep during the 
overnight study; 
• 
EXCL 3: History of allergic reactions to medical adhesives; 
• 
EXCL 4: Skin rash or other dermatological condition that would impact correct placement of the 
DreamKit device and/or PSG sensors, and/or would be exacerbated by the presence of the device 
or sensors; 
• 
EXCL 5: Presence of a pacemaker; 
• 
EXCL 6: Severe medical condition (controlled or uncontrolled) that would impede data collection in 
the opinion of the site investigator, including the requirement for oxygen therapy; 
• 
EXCL 7 [for those currently using overnight therapy]: Unwilling to withdraw from overnight therapy 
for a single night and/or clinically unsuitable to withdraw from overnight therapy in the opinion of the 
site investigator, with overnight therapy including but not limited to any form of PAP or ventilation, 
oral device including mandibular advancement devices or mouthguard for bruxism, nasal dilator 
strips, and/or positional device; 

 
 
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• 
EXCL 8 [for those currently using overnight therapy]: Considered by the site investigator to be at 
risk of an AE resulting from hypersomnolence the day after the overnight visit, such as a high-risk 
occupation including but not limited to a pilot or commercial driver; 
• 
EXCL 9: An employee, or family member of an employee, of a company that designs, sells, or 
manufactures sleep related products (including Philips). 
6.3. 
Enrollment 
All participants who sign the consent form will be considered enrolled, even if they do not complete the 
study. 
6.4. 
Screen Failures 
Participants who consent to participate in the study, but who do not meet one or more criteria required for 
participation, will be considered screen failures.  Minimal information will be collected for such participants, 
including demographics, screen failure details, eligibility criteria, and any AEs. 
Re-screening is possible if, in the opinion of the Principal Investigator or their designee, the reason for the 
original screen fail is likely to have changed and will not impact participant safety or data integrity.  Re-
screened participants should be assigned the same participant number as used for the initial screening. 
6.5. 
Strategies for Recruitment and Retention 
Participants will be recruited such that the overall sample will comprise approximately 50% OSA, 30% 
central sleep apnea (CSA; with or without Cheyne-Stokes respiration), and 20% healthy (no SDB).  
Recruitment for the OSA and CSA participants will proceed by targeting those with a known diagnosis 
and/or those currently using therapy for SDB and/or those considered by the site investigator to be high-
risk.  The sites may choose to administer the STOP-BANG questionnaire9 during phone screening for risk 
stratification, but this is optional.  Due to night-to-night SDB severity variability as well as the natural history 
of SDB, the diagnosis of each participant may not be known ahead of time and as such, our 
inclusion/exclusion criteria do not reference OSA or CSA diagnostic criteria. 
The PSGs will be scored throughout the study, and each participant will be assigned to a diagnostic 
category (see Section 8.1.6).  This information will be used to guide further recruitment to ensure the 
proportions of OSA, CSA, and no SDB referenced above, as well as to ensure a wide range of SDB 
severity.  The diagnostic category assigned in this study will be based solely on PSG scoring output without 
any other clinical information, and will have no bearing on clinical care. 
It is anticipated that racial/ethnic minorities will represent at least 20% of the sample, and that males and 
females will comprise at least 30% of the sample each.  These parameters are approximate expectations 
only. 

 
 
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All participants will be enrolled within the US.  Recruitment will be the responsibility of the site, and will take 
place through advertisements, the pipeline at local clinic/s, and/or by inspection of local medical records.  
As this study has only two visits, it is not likely that participants will drop-out or be lost to follow-up before 
study completion and therefore no specific strategies for retention are required. 
 
 

 
 
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7. 
STUDY INTERVENTION 
The DreamKit device is a non-released, investigational product.  The previous generation device, 
SomnaPatch, is FDA-approved (K183625); however, the DreamKit device has been modified from this 
version. 
The actigraphy device (GENEActiv Original; Activinsights, United Kingdom) is a released, 510(k) exempt 
product.  PSGs will be acquired through a variety of platforms; all are released products.  Released 
products will be utilized according to their intended use. 
7.1. 
Acquisition and Accountability 
All devices (used and un-used) will be shipped to the sites and then returned to the Sponsor at the end of 
the study.  An inventory of devices will be maintained. 
7.2. 
Formulation, Appearance, Packaging, and Labeling 
The DreamKit Device Label, User Manual and Operating Manual are included with the IRB submission.  
Some content of these documents may change before regulatory submission. 
7.3. 
Product Storage and Stability 
The DreamKit device should not be used in temperatures above 35 degrees Celsius (95 degrees 
Fahrenheit). 
7.4. 
Preparation 
The DreamKit devices are single use, and do not require configuration prior to use.  The investigator is 
required to peel off the adhesive backing, and place the forehead patch above the eyebrows in the center 
of the forehead, after thoroughly prepping the skin.  Calibration of the device begins automatically without 
user input, taking approximately five minutes to complete. 
 
 

 
 
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8. 
STUDY PROCEDURES & EVALUATIONS 
8.1. 
Efficacy Assessments  
8.1.1. Phone screening 
Recruitment will be the responsibility of the sites.  Potential participants will be screened over the phone 
for eligibility, and then scheduled for an enrollment visit.  The sites may choose to administer the STOP-
BANG questionnaire during phone screening for SDB risk stratification, but this is optional and responses 
will not be captured in the dataset. 
8.1.2. Visit 1: Office visit for enrollment 
Preliminary assessment of eligibility will be performed by the site investigator or their designee during Visit 
1, which is anticipated to take approximately one hour.  The investigator or their designee will then describe 
the purpose of the study, all study procedures, and possible risks of participation.  After an opportunity to 
ask questions, consent will be sought by the investigator or their designee. 
Following consent, an investigator will perform a brief physical examination and medical history, including 
anthropometric measurements (height; weight; neck, waist, and hip circumferences).  The examination will 
include vital signs (blood pressure obtained while seated according to American Heart Association 
guidelines,10 pulse rate, respiratory rate, and SpO2).  
Participants will then complete a brief battery of questionnaires including a descriptive questionnaire 
(including sociodemographics, usual sleep routine, and current medical conditions); the Epworth 
Sleepiness Scale;11 the Fitzpatrick skin type questionnaire;12 and the short-form versions of the Patient-
Reported Outcomes Measurement Information Systems (PROMIS) sleep disturbance and sleep-related 
impairment surveys.13 
If the participant is found to be eligible, they will be scheduled for Visit 2 within six weeks of the enrollment 
visit.  Note that the office visit (enrollment) and the laboratory visit (testing) may be combined, if logistically 
feasible. 
8.1.3. Visit 2: Overnight laboratory visit for testing 
Participants will be asked to attend Visit 2 for overnight testing.  The visit is anticipated to take 
approximately 12 hours.  Prior to any testing, each participant will be guided through what to expect during 
the visit. 
Polysomnography 
A registered polysomnographic technologist (RPSGT) or otherwise qualified individual will be responsible 
for setting up and overseeing the PSG according to AASM guidelines.  The PSG will include, at minimum, 

 
 
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electroencephalography (EEG; F4-M1, C4-M1, O2-M1, with back-up signals F3-M2, C3-M2, O1-M2), 
electrooculography (EOG; E1-M2 and E2-M2), electrocardiography (ECG), chin electromyography (EMG; 
ChinZ, Chin1, and Chin2), leg EMG (longitudinally and symmetrically over the middle of each anterior 
tibialis), pulse oximetry, airflow assessed by nasal pressure and oronasal thermistry, thoracic and 
abdominal respiratory inductance plethysmography (RIP) belts, and body position (supine, lateral, prone).  
The PSG will include a digital video recording per AASM recommendations.14  Electrode placement 
specifications are from the AASM scoring rules Section IV Part 1. 
Placement of DreamKit device 
A DreamKit device will be placed on each participant per the supplied instructions.  Thorough skin 
preparation is required before placement.  As the PSG and HSAT both require nasal cannulae, Philips will 
supply a ‘t-tube’ allowing a single nasal cannula to contribute an airflow signal to both platforms.   
Placement of actigraphy device 
The participant ID, sampling frequency (20Hz) and measurement duration (set to 7 days) are required in 
order to configure each actigraphy device using the GENEActiv software that will be supplied to study sites. 
Following configuration, the actigraphy device will be placed on the non-dominant wrist, and recording 
initiated.  A bandage/gauze can be placed underneath the device if desired.  The actigraphy device will 
stay in place until the completion of the PSG.  The GENEActiv configuration/download software should be 
installed on the same computer that runs the PSG platform, to ensure synchronization by using the same 
timestamp. 
Note that if a participant is unwilling or unable to wear the actigraphy device, for example due to a 
dermatological condition, they can complete the remainder of the protocol without actigraphy.   
PSG calibration procedure 
After initiating the recording but prior to lights-out, the RPSGT will work through the following calibration/bio-
calibration procedure: 
• 
Perform and document an impedance check of the EEG, EOG, and EMG electrodes; 
• 
Record a minimum of 30 seconds of EEG with participant awake lying quietly with eyes open; 
• 
Record a minimum of 30 seconds of EEG with participant awake lying quietly with closed open; 
• 
Ask the participant to look up and down without moving head (x5); 
• 
Ask the participant to look left and right without moving head (x5); 
• 
Ask the participant to blink (x5); 
• 
Ask the participant to grit teeth and /or chew (5 seconds); 

 
 
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• 
Ask the participant to simulate a snore or hum (5 seconds); 
• 
Ask the participant to breathe normally and ensure that airflow and respiratory effort signals are 
synchronized; 
• 
Ask the participant to perform a breath-hold (10 seconds); 
• 
Ask the participant to breathe normally and upon instruction, take a breath in and out, while checking 
polarity and mark the in/out accordingly; 
• 
Ask the participant to breathe through the nose only (10 seconds); 
• 
Ask the participant to breathe through the mouth only (10 seconds); 
• 
Ask the participant to take a deep breath and hold it, and while holding his/her breath push the 
stomach in and out 4 times; 
• 
Ask the participant to flex the left foot/raise toes on left foot (x5); 
• 
Ask the participant to flex the left foot/raise toes on right foot (x5). 
Overnight monitoring 
The technologist responsible for the PSG will ensure that all signals are free from artifact at study initiation.  
If sensors become dislodged, the technologist will endeavor to reattach or replace in order to obtain high-
quality signals throughout the night.  The technologist will complete a case report form (CRF) logging the 
exact lights off and lights on times, as well as any signal quality or other issues that arise during each PSG. 
Morning procedure  
In the morning, the technologist will remove all sensors and the participant will be free to leave the 
laboratory.   
Data transfer and device returns 
Study staff will download the raw PSG, DreamKit, and actigraphy data files using the appropriate software 
provided, and send all electronic data files to Philips using an approved, encrypted method.  Alternatively, 
the DreamKit devices will be returned allowing the data download to take place at Philips.  The adhesive 
backing will be replaced on each DreamKit device before returning the devices to Philips.  The actigraphy 
devices will be cleaned and re-used, and returned to Philips at the end of the study. 
8.1.4. Adverse event monitoring 
AE monitoring will take place throughout the study.  Participants will be provided with contact details should 
any AEs arise following the final study visit. 

 
 
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8.1.5. Data processing and scoring 
All data processing will take place at Philips using Sleepware software.  The analyst will import the 
DreamKit and PSG signals, ensuring that the signals are mapped correctly.  The analyst will then inspect 
the time alignment of the DreamKit and PSG signals; if necessary, the DreamKit time may be adjusted to 
ensure synchronization with the PSG pulse rate and/or flow signal/s recorded from the shared nasal 
cannula. 
Automated scoring using Somnolyzer will be used for PSG and DreamKit respiratory event detection within 
the rest period (time between lights off and lights on).  Sleep staging during the rest period will be 
undertaken using Somnolyzer (PSG) or CReSS (DreamKit) algorithms.  Sleep staging and event scoring 
will follow AASM guidelines.14  Apneas will be scored when there is a ≥90% reduction in airflow for at least 
ten seconds (Section IX Part 1, G1), and classified as obstructive (continued or increased respiratory effort 
throughout), central (absence of respiratory effort throughout), or mixed (initial absence followed by 
resumption of respiratory effort).  For our primary and secondary analyses, hypopneas will be scored 
according to the AASM recommended criteria; that is, a ≥30% reduction in airflow for at least ten seconds, 
associated with a SpO2 desaturation of ≥3% (Section IX Part 1, H1A).  We will perform a sensitivity analysis 
in which hypopneas are scored according to the alternative criteria (a ≥30% reduction in airflow for at least 
ten seconds, associated with a SpO2 desaturation of ≥4%; Section IX Part 1, H1B). 
The following metrics will be calculated for both the PSG and DreamKit: 
• 
AHI: Number of apneas and hypopneas divided by TST; 
• 
CAI: Number of central apneas divided by TST; 
• 
ODI: Number of SpO2 desaturations (≥3%) divided by TST. 
8.1.6. Signal quality and other feedback to sites 
Data processing and scoring will take place throughout the study, allowing continual feedback from Philips 
to the sites. 
The AASM clinical practice guidelines state that a diagnosis can be made using a HSAT only if the 
recording includes at least four hours of technically adequate oximetry and flow data;15 studies that do not 
meet these criteria will not be included in the evaluable dataset.  Collection of persistent invalid PSGs or 
other quality issues may prompt Philips to request the site to undergo troubleshooting or re-training.  Note 
that if a PSG is excluded from the evaluable dataset for technical reasons but the investigator considers 
the participant to be suitable for a repeat test, a repeat overnight visit can be scheduled. 
Each PSG will be categorized as follows (note that these categories are not mutually exclusive; as such, 
groups will be filled in the order listed below): 
• 
PSG-CAI ≥30 events/hour (~10% of sample); 

 
 
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• 
PSG-OAI ≥30 events/hour (~17% of sample); 
• 
PSG-CAI 15-29.9 events/hour (~10% of sample); 
• 
PSG-OAI 15-29.9 events/hour (~17% of sample); 
• 
PSG-CAI 5-14.9 events/hour (~10% of sample); 
• 
PSG-OAI 5-14.9 events/hour (~17% of sample); 
• 
PSG-AHI <5 events/hour (~20% of sample). 
The proportion of participants falling into these categories across all sites will be conveyed to sites 
periodically, along with guidance to optimize recruitment according to the approximate goals listed in 
Section 6.5.  Note that the category assigned during this process may differ from a clinical diagnosis; this 
process will take place only to ensure that recruitment proceeds according to the description in Section 6.5. 
8.1.7. Compensation 
Participants will be compensated $50 for the office visit and $150 for the data collection visit ($200 in total).  
Participants who opt to discontinue from the study will be prorated at the time of withdrawal. 
8.2. 
Safety Assessments 
All study procedures will take place during study visits, under the supervision of the Principal Investigator.  
The Principal Investigator is a physician and all visits will take place at a clinical facility, allowing for clinical 
intervention if needed.  The risks associated with the study are immediate; that is, it is considered highly 
unlikely that an AE will take place after the completion of a study visit. 
If any participants discontinue or withdraw early, for any reason including AEs, the reason will be captured. 
 
 

 
 
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9. 
DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
9.1. 
Discontinuations and Withdrawals 
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
• 
Pregnancy; 
• 
Significant study non-compliance; 
• 
If any AE, laboratory abnormality, or other medical condition or situation occurs such that continued 
participation in the study would not be in the best interest of the participant; 
• 
Any disease progression or medical condition which requires discontinuation; 
• 
If the participant meets an exclusion criterion (either newly developed or not previously recognized) 
that precludes further study participation; 
• 
At the discretion of the site investigator for any reason. 
• 
If a participant wishes to voluntarily discontinue from the study, they should contact the site directly.  
AE monitoring will continue for all participants who voluntarily discontinue the study or are 
withdrawn from the study by investigators. 
9.2. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she fails to return for Visit 2 and is unable to be 
contacted by the study site staff. 
9.3. 
Impact on Recruitment 
Participants who do not complete the study will be replaced.  Recruitment will continue until the evaluable 
dataset is complete. 
 
 

 
 
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10. 
RISK/BENEFIT ASSESSMENT 
10.1. Known potential risks 
A. The only anticipated adverse event (AE) related to the DreamKit device is skin irritation associated 
with the adhesive patch. 
B. Anticipated AEs associated with PSG include skin irritation or discomfort from the sensor 
placement, and possible sleep fragmentation leading to hypersomnolence the following day. 
C. A subset of participants may be required to withdraw from their usual overnight therapy (including 
but not limited to PAP, adaptive servo-ventilation, or oral appliance) during the overnight visit.  
Withdrawal of therapy for a single night may cause hypersomnolence the following day. 
D. The PSG will include video monitoring, which may cause some discomfort to participants.   
E. Some participants may feel uncomfortable answering questions regarding their sleep habits. 
F. Wrist actigraphy is included as an exploratory component of the protocol (see Section 4.6).  The 
only anticipated AE related to the actigraphy device is skin irritation associated with the placement 
of the device on the wrist. 
10.2. Known potential benefits 
Participation in this trial will not result in direct benefit to the participant.   
10.3. Assessment of Potential Risks and Benefits  
A. Participants reporting a history of allergic reactions to medical adhesives will not be recruited. 
B. Participants reporting a history of skin rashes or atopic dermatitis will not be recruited if the condition 
is likely to impact the placement of, or be exacerbated by, the DreamKit and/or PSG sensors.   
C. Participants who are required to be withdrawn from overnight therapy will not be recruited if they 
are engaged in a high-risk occupation such as commercial driving.  The investigator at each site 
will undertake a risk assessment when considering the withdrawal of therapy for a single night, 
where applicable. 
D. Participants will be informed about the overnight video monitoring during the consent process, and 
will have the option to opt-out of this component of the PSG. 
E. Participants will be informed that they may choose not to answer questions that make them 
uncomfortable; however, this may impact their ability to participate in the remainder of the study.  
At minimum, completion of sociodemographic data (age, sex, race/ethnicity) is required in order to 
remain enrolled. 

 
 
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F. Participants reporting a history of skin rashes or atopic dermatitis likely to impact the placement of, 
or be exacerbated by, the presence of a wrist actigraphy device can complete the protocol without 
actigraphy.  A dermatological condition impacting only the actigraphy device is not grounds for 
exclusion from the protocol. 
It is the opinion of the Sponsor and the Principal Investigator that the benefits of this protocol outweigh the 
risks. 
 
 

 
 
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11. 
SAFETY MONITORING 
11.1. Adverse Events and Serious Adverse Events 
11.1.1. Definition of Adverse Events 
An AE is any untoward medical occurrence associated with the use of an intervention in humans, whether 
or not considered intervention-related (21 CFR 312.32 (a)).  When an AE is deemed to be related to the 
study device, it is termed an adverse device event. 
11.1.2. Definition of Serious Adverse Events 
An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or 
Sponsor, it results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization 
or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of 
the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events 
that may not result in death, be life-threatening, or require hospitalization may be considered serious when, 
based upon appropriate medical judgment, they may jeopardize the participant and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition.  When a serious AE is 
deemed to be related to the study device, it is termed a serious adverse device event (SADE). 
11.2. Unanticipated Adverse Device Event 
An unanticipated adverse device event (UADE) is defined in 21 CFR Part 812.3(s) as “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 serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects”. 
Other important medical events which may not result in any of the outcomes above, but which may require 
intervention to prevent one of the outcomes above, may in the opinion of the investigator, be considered a 
UADE. 
11.3. Classification of an Adverse Event or Adverse Device Event 
11.3.1. Severity of Event 
All AEs will be assessed by the study clinician using a protocol defined grading system as follows: 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  

 
 
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• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy 
or other treatment. Severe events are usually potentially life-threatening or incapacitating.  Of note, 
the term “severe” does not necessarily equate to “serious”. 
11.3.2. Relationship to the Study or Device 
All AEs will have their relationship to study procedures and the study device assessed by the clinician who 
examines and evaluates the participant based on temporal relationship and his/her clinical judgment. The 
degree of certainty about causality will be graded using the categories below.  
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test result, 
occurs in a plausible time relationship to study intervention administration and cannot be explained 
by concurrent disease or other drugs or chemicals. The response to withdrawal of the study 
intervention (dechallenge) should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive, with use of a satisfactory rechallenge procedure if necessary. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the study intervention, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal (dechallenge). Rechallenge information is not required to fulfill this definition. 
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of the trial medication). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other concomitant 
events). Although an AE may rate only as “possibly related” soon after discovery, it can be flagged 
as requiring more information and later be upgraded to “probably related” or “definitely related”, as 
appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study intervention administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study intervention) 
and in which other drugs or chemicals or underlying disease provides plausible explanations (e.g., 
the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study intervention administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an alternative, 
definitive etiology documented by the clinician). 

 
 
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11.3.3. Expectedness  
The Principal Investigator will be responsible for determining whether an AE is expected or unexpected.  
An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the study intervention. 
11.4. Adverse Event Assessment and Follow-Up 
Within 1-7 days of completing Visit 2, a phone call will allow for the assessment of any possible AEs that 
may have become apparent in the intervening period.  Events will be followed for outcome information until 
resolution or stabilization 
All AEs including local and systemic reactions not meeting the criteria for a serious adverse event (SAE) 
will be captured on the appropriate (e)CRF. Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 
occurring while on study must be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any time 
during the study, it will be recorded as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of onset 
and duration of each episode. 
11.5. Serious Adverse Event or Serious Adverse Device Event Reporting  
The study investigator shall complete a SAE or UADE Form and submit to the Sponsor and to the reviewing 
IRB as soon as possible, but in no event later than 24 hours (for a SAE) or 10 working days (for a UADE) 
after the investigator first learns of the effect.  The Sponsor is responsible for conducting an evaluation of 
the SAE/UADE and shall report the results of such evaluation to the Food and Drug Administration (FDA) 
and to all reviewing IRBs and participating investigators within 24 hours (for a SAE) or 10 working days (for 
a UADE) after the Sponsor first receives notice of the effect. Thereafter, the Sponsor shall submit such 
additional reports concerning the effect as FDA requests. 
11.6. Device Deficiency 
All device deficiencies, use or user errors, and equipment failures will be documented.  Use or user errors 
will be captured as part of the source documentation.  Device deficiencies and equipment failures will be 
kept on a separate log.  The serial numbers and type of deficiency/failure will be captured. Unanticipated 

 
 
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device deficiencies that lead or may lead to an SAE will be reported to the Sponsor within 24 hours of 
learning of the event. 
11.7. Unanticipated Problems 
11.7.1. Definition of Unanticipated Problems 
An unanticipated problem (UP) is any incident, experience, or outcome that for which the nature, severity, 
or frequency is unexpected for the subject population or research activities as described in the current IRB 
approved protocol, supporting documents, and the consent form. 
11.7.2. Unanticipated Problem Reporting 
The Principal Investigator will submit to the Sponsor and to the reviewing IRB a report of any UADE 
occurring during an investigation as soon as possible, but in no event later than 10 working days after the 
investigator first learns of the effect (21 CFR 812.150(a)(1)).  Under 812.46(b), the Sponsor shall report the 
results of such evaluation to the FDA and to all reviewing IRB's and participating investigators within 10 
working days after the Sponsor first receives notice of the effect. Thereafter the Sponsor shall submit such 
additional reports concerning the effect as FDA requests (21 CFR 812.150(b)(1)). 
 
 

 
 
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12. 
STATISTICAL CONSIDERATIONS 
The statistical analysis plan has been incorporated into this protocol.  It is not a stand-alone document. 
12.1. Statistical Analyses 
12.1.1. Sample Size Determination 
The endpoint associated with Hypothesis 2 (ICC between PSG-CAI and DreamKit-CAI) exhibits a weaker 
effect size than the endpoint associated with Hypothesis 1 (ICC between PSG-AHI and DreamKit-AHI). 
Pilot data from a sample of 178 records exhibited an ICC between the PSG-CAI and DreamKit-CAI 0.720 
(95% CI 0.641 – 0.784).  We will compare the lower-bound of the CI (0.641) to a threshold of 0.50, per 
Hypothesis 2.  Assuming 90% power and an alpha of 0.05, n=195 participants will be required to test 
Hypothesis 2. 
The same sample exhibited an ICC between the PSG-AHI and DreamKit-AHI of 0.908 (95% CI 0.879 – 
0.931).  We will compare the lower-bound of the CI (0.879) to a threshold of 0.75, per Hypothesis 1.  
Assuming 90% power and an alpha of 0.05, n=56 participants will be required to test Hypothesis 1.  Thus, 
the sample size required for Hypothesis 2 (n=195) is more than adequate for Hypothesis 1, and we will 
adopt an overall sample size of n=200. 
12.1.2. General Considerations 
The primary and secondary analyses will be performed after excluding studies that do not meet the AASM 
criteria for technical adequacy described in Section 8.1.6 (evaluable dataset).  Continuous data will be 
presented by mean, standard deviation, median, minimum, and maximum observation.  Data will be 
presented in the untransformed and transformed format (if applicable) for each continuous variable.  
Categorical data will be presented as frequencies and percentages.  Significance tests will be conducted 
at a two-sided significance level of alpha of 0.05. 
12.1.3. Participant Disposition 
Participant disposition, including the total number of participants enrolled, completed, early terminations, 
and withdrawals, will be presented.  A listing will be provided with the reasons for discontinuation.  
12.1.4. Demographics and Baseline Characteristics 
Participant demographics (age, sex, race/ethnicity) and descriptive characteristics will be summarized for 
all participants enrolled and for evaluable participants. 

 
 
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12.1.5. Analysis of the Primary Endpoint 
We will calculate the ICC for absolute agreement (two-way, mixed effect) between the AHI-PSG and 
DreamKit-AHI, along with a 95% CI.  Hypothesis 1 will be supported if the lower-bound of the 95% CI is 
equal to or above 0.75. 
12.1.6. Analysis of the Secondary Endpoint 
We will calculate the ICC for absolute agreement (two-way, mixed effect) between the AHI-CAI and 
DreamKit-CAI, along with a 95% CI.  Hypothesis 2 will be supported if the lower-bound of the 95% CI is 
equal to or above 0.50. 
For the primary and secondary endpoints, the AASM recommended definition of hypopnea will be used. 
12.1.7. Adjustment for Multiplicity 
We have adopted a single primary endpoint, and will progress to the secondary endpoint only if the primary 
hypothesis is supported.  There is therefore no requirement for an adjustment to control the false discovery 
rate. 
12.1.8. Exploratory Analyses 
Analyses of indices 
• 
We will calculate the ICC for absolute agreement (two-way, mixed effect) between the PSG and 
DreamKit ODI3%, total respiratory events, total apneas, total hypopneas, total obstructive apneas, 
total central apneas, and total mixed apneas, along with 95% CIs. 
• 
We will construct a confusion matrix and calculate Cohen’s kappa (linear weighted) for four 
categories of disease severity determined by the PSG and DreamKit (AHI 0-4.9, 5-14.9, 15-29.9, 
and ≥30 events/hour). 
• 
We will construct a confusion matrix depicting true-positives, false-positives, true-negatives, and 
false-negatives for the AHI, CAI, and ODI3% (separately) at thresholds of 5, 15, 20, 30, and 40 
events/hour. 
• 
We will calculate the accuracy (percentage agreement between PSG and DreamKit), sensitivity, 
specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative 
likelihood ratio for each threshold of the above indices. 
• 
We will construct a receiver operating characteristic curve and calculate the area under the curve 
for each threshold of the above indices. 
• 
We will construct a Bland-Altman plot for each threshold of the above indices, including a 95% CI 
for the upper and lower limits of agreement. 

 
 
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• 
We will construct a scatter plot with regression line for each threshold of the above indices. 
• 
We will repeat all analyses listed above using the AASM alternative hypopnea criteria. 
Event-level analyses 
• 
We will construct a 2x2 confusion matrix based on the presence/absence of events by adapting the 
methodology described in the AASM Inter-Scorer Reliability Program: Respiratory Events (2014).16  
Each epoch staged as sleep per the PSG will be deemed ‘positive’ if it contains at least one 
respiratory event of any type, and ‘negative’ if it contains no respiratory event/s.   
• 
We will construct a 4x4 confusion matrix based on apnea differentiation (obstructive apnea, central 
apnea, mixed apnea, no event), following the above methodology using events staged as sleep per 
the PSG, and calculate Cohen’s kappa.17  In cases where a single epoch contains more than one 
event, the first event will be used for categorization.  Mixed events will be categorized independently 
if we observe at least five mixed events/hour in at least 5% of participants and at least ten mixed 
events/hour in at least 2% of participants in the evaluable dataset; otherwise, mixed events will be 
placed in the obstructive category to create a 3x3 confusion matrix. 
Signal quality analyses 
• 
Finally, we will compare the average percentage of useable signal quality from the DreamKit 
respiratory effort signal (PARE algorithm) and PSG (thoracic and/or abdominal belts). 
12.2. Exploratory Analyses of Actigraphy Data 
Actigraphy is included in the protocol for exploratory product development purposes only.  All analyses of 
the actigraphy data will be conducted separately from the DreamKit analyses described above. 
12.3. Safety Analyses 
Safety evaluations will be performed by recording clinical AEs at the time originally reported, and they will 
be followed at regular intervals until resolution.  AEs will be provided in data listings. 
12.4. Planned Interim Analyses 
No interim statistical analyses will be undertaken.  There are no statistical criteria for terminating the study.   
12.5. Missing Unused and Spurious Data 
Imputation methods will not be employed in this study. 
12.6. Deviations from the Statistical Analysis Plan 
Any deviations from the original statistical plan will be noted in the analysis report. 
 

 
 
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13. 
OPERATIONAL CONSIDERATIONS 
13.1. Regulatory and Ethical Considerations 
13.1.1. Informed Consent Process 
Participants will be asked to complete the consent form prior to any study procedures, including screening 
for eligibility. 
In obtaining and documenting informed consent, the investigator must comply with applicable regulatory 
requirements (e.g., 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56) and should adhere to ICH GCP. 
Prior to the beginning of the trial, the investigator should have the IRB’s written approval for the protocol 
and the written informed consent form(s) and any other written information to be provided to the 
participants. 
Study participation is voluntary. Potential subjects, and/or their legal representatives, will be given the most 
current IRB-approved consent form to read.  They shall be provided ample time for review and an 
opportunity to ask questions about the study.  If they agree to participate, they shall sign the consent form 
and be given a copy of the signed document for their records.  Each of these actions/steps will be 
documented.  Only after informed consent has been obtained, may the remaining study procedures begin. 
13.1.2. Consent Procedures and Documentation 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Consent forms will be IRB-approved and the 
participant will be asked to read and review the document. The investigator will explain the research study 
to the participant and answer any questions that may arise. A verbal explanation will be provided in terms 
suited to the participant’s comprehension of the purposes, procedures, and potential risks of the study and 
of their rights as research participants.  Participants will have the opportunity to review the written consent 
form carefully and ask questions prior to signing. The participants should have the opportunity to discuss 
the study with their family or surrogates or think about it prior to agreeing to participate.  Participants must 
be informed that participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. A copy of the informed consent document will be given to the participants for their records. The 
informed consent process will be conducted and documented in the source document (including the date), 
and the form signed, before the participant undergoes any study-specific procedures. The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their medical care 
will not be adversely affected if they decline to participate in this study. 
13.1.3. Study Discontinuation and Closure 
Although there are no pre-determined criteria for study closure, the study may be temporarily suspended 
or prematurely terminated if there is sufficient reasonable cause.  If the study is prematurely terminated or 

 
 
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suspended, the Principal Investigator will promptly inform study participants, the IRB, and Sponsor, and 
will provide the reason(s) for the termination or suspension.  Study participants will be contacted, as 
applicable, and be informed of changes to study visit schedule. 
• 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants; 
• 
Insufficient compliance to protocol requirements; 
• 
Data that are not sufficiently complete and/or evaluable. 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, and 
satisfy the Sponsor, IRB and/or FDA. 
13.1.4. Confidentiality and Privacy  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
and the Sponsor. The study protocol, documentation, data, and all other information generated will be held 
in strict confidence. No information concerning the study or the data will be released to any unauthorized 
third party without prior written approval of the Sponsor.  
All research activities will be conducted in as private a setting as possible. 
The study monitor, other authorized representatives of the Sponsor, representatives of the IRB, or 
regulatory agencies may inspect all documents and records required to be maintained by the investigator, 
including but not limited to, medical records (office, clinic, or hospital) and pharmacy records for the 
participants in this study. The clinical study site will permit access to such records. 
Each study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as long 
a period as dictated by the reviewing IRB, institutional policies, or Sponsor requirements. 
Study participant research data for statistical analysis and scientific reporting will be transmitted to and 
stored by the Sponsor. This will not include the participant’s contact information. Rather, individual 
participants and their research data will be identified by a unique study identification number. The study 
data entry and study management systems used by clinical sites and by the Sponsor research staff will be 
secured and password protected. At the end of the study, all study databases will be de-identified with the 
exception of dates, and archived at the Sponsor. 
13.2. Future Use of Stored Specimens and Data  
Data collected for this study will be analyzed and stored at the Sponsor, where it may be used for future 
research.  During the conduct of the study, an individual participant can choose to withdraw consent to 

 
 
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have biological specimens stored for future research. However, withdrawal of consent with regard to data 
storage may not be possible after the study is completed.  
13.3. Safety Oversight 
Safety oversight is the responsibility of the Principal Investigator.  It has been determined that a Safety 
Monitoring Committee, Data and Safety Monitoring Board, Safety Assessment Committee and/or an 
Independent Safety Monitor is not required for this study. 
13.4. Clinical Monitoring 
This study will be monitored using a risk-based monitoring approach.  It will ensure that documents used 
to originally record subject data (source documents) are maintained, and to verify that transcribed data are 
accurately reflected on the study (e)CRFs.  All study documentation must be made available for review by 
the Sponsor or its designees as well as regulatory agencies. 
13.5. Quality Assurance and Quality Control 
The clinical sites will perform internal quality management of study conduct, data collection, documentation 
and completion. 
Quality control procedures will be implemented beginning with the data entry system and data quality 
control checks that will be run on the database will be generated. Any missing data or data anomalies will 
be communicated to the site(s) for clarification/resolution. 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the Sponsor, and inspection by local and regulatory 
authorities. 
13.5.1. Data Handling and Record Keeping  
The site will maintain appropriate medical and research records for this trial, in compliance with ICH GCP 
and regulatory and institutional requirements for the protection of confidentiality of participants.   
13.5.2. Data Collection and Management Responsibilities  
Data collection is the responsibility of the staff at the site under the supervision of the site investigator. The 
investigator is 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.   

 
 
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Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  Data recorded in the (e)CRF derived from source 
documents should be consistent with the data recorded on the source documents.  
Clinical data (including AEs), concomitant medications, and expected adverse reactions data) and clinical 
laboratory data will be entered into a 21 CFR Part 11-compliant data capture system provided by the 
Sponsor. The data system includes password protection and internal quality checks, such as automatic 
range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be 
entered directly from the source documents. 
13.6. Study Records Retention  
Study documents will be retained for a minimum of 2 years after the last approval of a marketing application 
in an ICH region and until there are no pending or contemplated marketing applications in an ICH region 
or until at least 2 years have elapsed since the formal discontinuation of clinical development of the study 
intervention. These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the Sponsor, if applicable. It is the 
responsibility of the Sponsor to inform the investigator when these documents no longer need to be 
retained. 
13.7. Protocol Deviations  
Any and all deviations from the protocol shall be documented upon discovery and reported in the subject’s 
(e)CRFs.  Significant deviations shall be reported immediately to the Sponsor. 
13.8. Publication and Data Sharing Policy 
The results of this clinical study may be submitted for publication.  The rights for publication of results from 
this study remain with Philips.  The Investigator must request permission from Philips prior to initiating any 
publication. Permission must be requested and received in writing.  Review and approval of any data, 
abstract or manuscript is required.  Philips reserves the right to delay publication to review the presentation 
of study methodology, data collection, data analysis, interpretation of data, proprietary information or 
patented technology.  A request for delay and the reason(s) shall be communicated by Philips to the 
Investigator in writing.  Philips ultimately reserves the right to deny any request to publish. 
13.9. Registration 
Philips will be registering this clinical study on ClinicalTrials.gov.   

 
 
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13.10. Conflict of Interest Policy 
The independence of this study from any actual or perceived influence is critical.  Therefore, any actual 
conflict of interest (apart from that related to Philips) of persons who have a role in the design, conduct, 
analysis, publication, or any aspect of this trial will be disclosed and managed.  Furthermore, persons who 
have a perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the design and conduct of this trial.   
 
 

 
 
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14. 
REFERENCES  
1. 
Rosen IM, Kirsch DB, Chervin RD, et al. Clinical Use of a Home Sleep Apnea Test: An American 
Academy of Sleep Medicine Position Statement. J Clin Sleep Med 2017;13(10):1205-1207. 
2. 
Kundel V, Shah N. Impact of Portable Sleep Testing. Sleep Med Clin 2017;12(1):137-147. 
3. 
Kim RD, Kapur VK, Redline-Bruch J, et al. An Economic Evaluation of Home Versus Laboratory-
Based Diagnosis of Obstructive Sleep Apnea. Sleep 2015;38(7):1027-1037. 
4. 
Skomro RP, Gjevre J, Reid J, et al. Outcomes of home-based diagnosis and treatment of 
obstructive sleep apnea. Chest 2010;138(2):257-263. 
5. 
Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for 
Reliability Research. J Chiropr Med 2016;15(2):155-163. 
6. 
Yalamanchali S, Farajian V, Hamilton C, Pott TR, Samuelson CG, Friedman M. Diagnosis of 
obstructive sleep apnea by peripheral arterial tonometry: meta-analysis. JAMA Otolaryngol Head Neck 
Surg 2013;139(12):1343-1350. 
7. 
Magalang UJ, Chen NH, Cistulli PA, et al. Agreement in the scoring of respiratory events and sleep 
among international sleep centers. Sleep 2013;36(4):591-596. 
8. 
Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: an updated list of essential items for 
reporting diagnostic accuracy studies. BMJ 2015;351(h5527. 
9. 
Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for 
Obstructive Sleep Apnea. Chest 2016;149(3):631-638. 
10. 
Pickering TG, Hall JE, Appel LJ, et al. Recommendations for blood pressure measurement in 
humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for 
professionals from the Subcommittee of Professional and Public Education of the American Heart 
Association Council on High Blood Pressure Research. Hypertension 2005;45(1):142-161. 
11. 
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 
1991;14(6):540-545. 
12. 
Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol 
1988;124(6):869-871. 
13. 
Yu L, Buysse DJ, Germain A, et al. Development of short forms from the PROMIS sleep disturbance 
and Sleep-Related Impairment item banks. Behav Sleep Med 2011;10(1):6-24. 
14. 
Berry RB, Brooks R, Gamaldo C, et al. AASM Scoring Manual Updates for 2017 (Version 2.4). J 
Clin Sleep Med 2017;13(5):665-666. 
15. 
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;13(3):479-504. 
16. 
Rosenberg RS, Van Hout S. The American Academy of Sleep Medicine Inter-scorer Reliability 
program: respiratory events. J Clin Sleep Med 2014;10(4):447-454. 

 
 
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17. 
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 
1977;33(1):159-174. 
 
 

 
 
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15. 
APPENDICES 
A. Informed consent form 
B. DreamKit Device Label 
C. DreamKit User Manual 
D. DreamKit Operating Manual 
E. Descriptive questionnaire 
F. Epworth Sleepiness Scale 
G. Fitzpatrick skin type questionnaire 
H. Short-form PROMIS sleep disturbance survey 
I. Short-form PROMIS sleep-related impairment survey 
J. STOP-BANG questionnaire 
 
 

 
 
Clinical Investigation Protocol ICH E6 Aligned 
 
 
Document 
ID: 
SRC_SLE_Sparkle_P
SG_2020_10908 
Document title: 
Classification: 
Confidential 
Modified: 
26 July 2021 
Clinical Investigation Protocol ICH E6 Aligned 
Version: 
5 
User Tool ID:  
16.2.6UserTool0004 
Page: 
48 
Status: 
Final 
User Tool Version Date 
5June2019 
 
16. 
INVESTIGATOR’S STATEMENT 
I agree to conduct the trial as outlined in the protocol in accordance with the Sponsor’s guidelines, Good Clinical Practices, the 
Declaration of Helsinki, and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB.  The 
Sponsor’s guidelines include, but are not limited to: 
• 
Provide Philips with current curriculum vitae including a statement regarding relevant experience. 
• 
Provide accurate financial disclosure information to allow Philips to make an accurate disclosure statement as required 
under 21 CFR, Part 54 for the course of the investigation and for up to one year after its completion  
• 
Provide supervision of all testing of the device involving human subjects.   
• 
If applicable, provide Philips with information regarding past investigations or other research that was terminated, 
including an explanation of the circumstances that led to the termination.   
• 
Permission to allow Philips and/or regulatory agencies to inspect study facilities and pertinent records at reasonable times 
and in a reasonable manner that ensures subject confidentiality.  If this study is to be inspected by a regulatory agency, 
Philips is to be notified as soon as possible. 
• 
Submission of the proposed clinical investigation including the protocol and the consent form to an IRB for approval and 
the acquisition of written approval for each subject ensuring that the requirements for obtaining informed consent are 
obtained prior to the use of any test articles. 
• 
Submission of any proposed change in or significant deviation from the protocol to the IRB using a signed formal 
amendment document prepared by the Sponsor.  Any proposed changes or deviations from the protocol require that the 
informed consent also reflects such changes or deviations and that the revised informed consent be approved by an IRB. 
• 
Documentation and explanation of individual protocol deviations and violations are captured with explanations as 
indicated. 
• 
Submission of reports of AEs to the Sponsor and IRB as outlined in the protocol. 
• 
Submission of timely progress reports to the IRB and Sponsor at appropriate intervals on a schedule determined by the 
IRB or Sponsor, as indicated. 
• 
Record keeping:  the Investigator shall maintain adequate and accurate records designed to record completion of all study 
procedures, related observations and other key data (such as safety, compliance and product accountability) pertinent to 
the investigation on each subject enrolled.  The investigator must maintain these records for a period as specified by 
Philips following completion of the study report. 
I agree that all information provided to me by the Sponsor including pre-clinical data, protocols, electronic databases, (e)CRFs, 
and verbal and written information shall be kept strictly confidential and confined to the clinical personnel involved in conduct of 
the trial.  It is recognized that this information may be related in confidence to the IRB.  I also understand that reports or information 
about the trial or its progress shall not be provided to anyone not involved in the trial other than the Sponsor or other legally 
constituted authority. 
____________________________________________________________ 
___________________ 
Principal Investigator Signature and Printed Name 
Date