CPAP In-home Assessment USA
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: Fisher and Paykel Healthcare

Created using TMP-51_c – Parent Procedure SP-290 
This document is not controlled when printed from the intranet. 
Refer to Fisher & Paykel Healthcare intranet for current revision. 
CONFIDENTIAL.  Fisher & Paykel Healthcare internal use only 
 
 
 
 
 
 
Clinical Investigation Plan: ICON 2 Pre-Release 
Assessment (PRA) USA (CIA-176)  
 
Document 
No. 
Rev 
Document Title  
(must be the same as Database/ hardcopy) 
Category-
Folder 
(e.g. DHF) 
Folder 
No. 
Folder  
Tab  
section 
(§)
CIA-176 
B 
Clinical Investigation Plan: ICON 2 
Pre-ReleaseA) USA 
CIA 
176 
2.4 
Additional copies to: 
 
Additional Notes: 
This is part of three ICON2 Pre-Release Assessments conducted in Australia (this 
CIA-175), New Zealand (CIA-174) and USA (CIA-176).  
 
Ethics approval date 
21 June 2016 
NCT number  
NCT02809859 
 
The approved hardcopy of this document shall be filed into the relevant 
Clinical Investigation Administration (CIA) folder under the Clinical 
Investigation Plan Tab 2.4 
 
 
 
 
 
 
 
 
Review and Approval 
Please tick if task complete: 
Pre-release database done  ,   File(s) in DRAFT & Closed   
 
Name 
Title 
Signature 
Date 
Irene Cheung 
Author 
Clinical Research 
Scientist 
 
 
Liz Goldstein 
Review 
Senior Regulatory 
Affairs Specialist 
 
 
Rachel Vicars 
Approval 
Senior Clinical 
Research Scientist 
 
 

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Table of Contents 
1. 
Revision History ....................................................................................................................... 4 
2. 
List of Abbreviations ................................................................................................................ 4 
3. 
Document Information .............................................................................................................. 4 
 Purpose and Scope ....................................................................................................... 4 
 Confidentiality Statement .............................................................................................. 4 
 Persons Authorized to Amend the CIP .......................................................................... 4 
 Monitoring Arrangements .............................................................................................. 4 
 Data Management ......................................................................................................... 5 
4. 
Investigator Information ........................................................................................................... 5 
 Study Principle Investigator ........................................................................................... 5 
4.1.1. Co-ordinating Investigator ......................................................................................................... 5 
 Investigators .................................................................................................................. 5 
4.2.1. Co-ordinating Investigator ......................................................................................................... 5 
 Investigators .................................................................................................................. 5 
4.3.1. Co-ordinating Investigator ......................................................................................................... 6 
 Investigators .................................................................................................................. 6 
4.4.1. Co-ordinating Investigator ......................................................................................................... 6 
4.4.2. Co-ordinating Investigator ......................................................................................................... 6 
 Other Investigators ........................................................................................................ 6 
 Institution....................................................................................................................... 6 
5. 
Sponsor Information ................................................................................................................. 7 
 Primary Sponsor Details ................................................................................................ 7 
6. 
Device Information.................................................................................................................... 7 
 Identification of the Medical Device ............................................................................... 7 
 Device Risk Analysis and Management ........................................................................ 8 
7. 
Justification for a Clinical Trial ................................................................................................ 8 
 Synopsis ....................................................................................................................... 8 
 Literature Review .......................................................................................................... 9 
 Preclinical Testing ......................................................................................................... 9 
 Previous Clinical Experience ......................................................................................... 9 
 Justification for Administration ..................................................................................... 10 
8. 
Objectives of the Clinical Investigation ................................................................................. 10 
 Hypothesis .................................................................................................................. 10 
 Objectives ................................................................................................................... 10 
 Population ................................................................................................................... 10 
 Risks ........................................................................................................................... 10 
 Essential Requirements of the Relevant Directive ....................................................... 11 
9. 
Clinical Investigation Design ................................................................................................. 11 
 Type of Investigation ................................................................................................... 11 
 Controls ...................................................................................................................... 11 
 Bias ............................................................................................................................. 11 
 End Points ................................................................................................................... 11 

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9.4.1. Primary Outcomes .................................................................................................................. 11 
9.4.2. Secondary Outcomes ............................................................................................................. 11 
 Variables ..................................................................................................................... 11 
 Measurements ............................................................................................................ 12 
 Equipment ................................................................................................................... 12 
 Inclusion / Exclusion criteria ........................................................................................ 12 
 Point of Enrolment ....................................................................................................... 13 
 Patient Procedure ....................................................................................................... 13 
 Withdrawal Criteria ...................................................................................................... 14 
 Number of Trial Subjects ............................................................................................. 15 
 Follow up Plan ............................................................................................................ 15 
 Foreseeable Complications ......................................................................................... 15 
10. 
Clinical Trial Documentation .................................................................................................. 15 
 Consent and Recruitment ............................................................................................ 15 
 Case Report Form ....................................................................................................... 15 
10.2.1. 
Case Report Form Signatories .......................................................................................... 15 
 Insurance Statement ................................................................................................... 15 
 Record of Deviations ................................................................................................... 16 
STATISTICAL CONSIDERATIONS ............................................................................................................ 16 
 Description of the Statistical Design ............................................................................ 16 
 Sample Size ................................................................................................................ 16 
 Pass/Fail Criteria ......................................................................................................... 16 
 Statistical Termination ................................................................................................. 17 
 Statistical Procedure Deviations .................................................................................. 17 
 
Selection Criteria .................................................................................................... 17 
 
Statistical Data Management .................................................................................. 17 
11. 
Adverse Events and Termination .......................................................................................... 17 
 Emergency Contact Details ......................................................................................... 17 
 Foreseeable Adverse Events ...................................................................................... 18 
 Reporting Adverse Events ........................................................................................... 18 
 Early Termination ........................................................................................................ 18 
11.4.1. 
Investigator ......................................................................................................................... 18 
11.4.2. 
Sponsor .............................................................................................................................. 19 
11.4.3. 
Institutional Review Board (IRB) ........................................................................................ 19 
12. 
Publication Policy ................................................................................................................... 19 
13. 
Approval .................................................................................................................................. 19 
14. 
References .............................................................................................................................. 19 
15. 
Appendix A: Initial Impression Questionnaire ...................................................................... 21 
16. 
Appendix B: Perception Questionnaire ................................................................................. 22 
  
 
 
 

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1. 
Revision History 
Revision 
Author 
Date 
Description of change 
A 
Irene Cheung 
12 April 2016 
First release 
B 
Irene Cheung 
21 June 2016 
Administrative changes to the questionnaire in 
Appendix A and B 
 
Changed sponsor contact person to Hanie Yee 
(Clinical Research Manager) 
 
Changed reporting of adverse events to Hanie Yee 
(Clinical Research Manager) 
2. 
List of Abbreviations 
AutoCPAP 
Auto-adjusting Continuous Positive Airway Pressure 
CIP 
 
Clinical Investigation Plan 
CPAP  
Continuous Positive Airway Pressure 
CRF 
 
Case Report Form 
FPH 
 
Fisher & Paykel Healthcare 
HIPPA  
Health Insurance Portability and Accountability Act 
IB  
 
Investigator’s Brochure 
IRB 
 
Institutional Review Board 
OSA 
 
Obstructive Sleep Apnea 
3. 
Document Information 
 
Purpose and Scope 
This clinical investigation plan (CIP) is compiled by the investigators and sponsor (Fisher & Paykel 
Healthcare (FPH)). The CIP is designed to optimize the scientific validity and reproducibility of the 
results of this study in accordance with current clinical knowledge and practice so as to fulfil the 
objectives of the investigation. The investigator and the sponsor will store the current copy and all 
previous copies of the CIP. 
 
The purpose of the clinical investigation, ICON 2 Pre-Release Assessment USA (CIA-176) is listed in 
Section 8 Objectives of the Clinical Investigation.  
 
 
Confidentiality Statement 
This document contains confidential information belonging to Fisher & Paykel Healthcare and is 
provided for the sole purpose of enabling an evaluation of a possible collaboration with Fisher & Paykel 
Healthcare to undertake the proposed clinical research. This document must be maintained in a 
confidential manner at all times and any disclosure, distribution or reproduction of this document outside 
the intended purpose is prohibited. 
 
 
Persons Authorized to Amend the CIP 
Irene Cheung – Clinical Research Scientist, Fisher & Paykel Healthcare 
Rachel Vicars – Senior Clinical Research Scientist, Fisher & Paykel Healthcare 
Hanie Yee – Clinical Research Manager, Fisher & Paykel Healthcare 
 
 
Monitoring Arrangements 
Sites will be monitored by a representative of Fisher & Paykel Healthcare or by a representative of 
Clayton Sleep Institute at least twice during the study: 
 
After the first 3 patients have been recruited into the study, and completed the first visit.  

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 
After all patients have completed the study. 
 
At each monitoring visit, the following records will be verified for all patients recruited into the study at 
that time point: 
 
Site regulatory file 
 
Informed consent  
 
Confirmation of inclusion/exclusion criteria from the patient’s physician 
 
Completed Case Report Forms 
 
Device accountability  
The details can be found in the monitoring plan. 
 
 
Data Management  
Data obtained for this investigation will be stored in the controlled document system and electronically 
on secure servers, which are only accessible by Clinical Research staff and those persons identified on 
the delegation of authority. Any data which is not kept in this secure manner will be de-identified in 
accordance with Health Insurance Portability and Accountability Act (HIPPA) protocols. 
4. 
Investigator Information 
 
 
Study Principle Investigator 
Name: Matt Uhles 
Address: Clayton Sleep Institute, 2531 S. Big Bend Boulevard, St Louis, Missouri, 63143 
Email: uhlesm@claytonsleep.com 
Phone: 314-645-6005 
Professional Position: Operational Director of Clayton Sleep Institute 
4.1.1. Co-ordinating Investigator 
Name: Angela Lindsey 
Address: Clayton Sleep Institute, 2531 S. Big Bend Boulevard, St Louis, Missouri, 63143 
Email: LindseyA@claytonsleep.com 
Phone: 314-645-6005 
Professional Position: Clinical Research Coordinator 
 
 
 
Investigators  
Investigator: Edward M.Turpin, MD 
Address: Alabama Sleep Clinic, 4810 Whitesport Circle, Suite 110, Huntsville, Alabama 35801 
Email: ETurpinMD@alabamasleepclinic.com 
Phone: 256-539-2531 
Professional Position: Certified Sleep Physician 
4.2.1. Co-ordinating Investigator 
Name: Dixie Craft 
Address: Alabama Sleep Clinic, 4810 Whitesport Circle, Suite 110, Huntsville, Alabama 35801 
Email: dcraft@alabamasleepclinic.com 
Phone: 256-539-2531 
Professional Position: CPAP Coordinator 
 
 
 
Investigators  
Investigator: Thomas W. O’Brien, MD 

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Address: Central Florida Sleep Centre, 1121 N. Central Avenue, Kissimmee, FL 34741 
Email: pi@PDS-CFSC.com  
Phone: 407-624-4831 
Professional Position: President of Central Florida Sleep Centre 
4.3.1. Co-ordinating Investigator 
Name: Margaret Bell 
Address: Central Florida Sleep Centre, 1121 N. Central Avenue, Kissimmee, FL 34741 
Email: mbell@PDS-CFSC.com 
Phone: 407-624-4831 
Professional Position: Research Site Director 
 
 
 
Investigators  
Investigator: Asim Roy, MD 
Address: Ohio Sleep Medicine Institute, 4975 Bradenton Avenue, Dublin, Ohio 43017 
Email: aroy@sleepmedicine.com  
Phone: 614-766-0773 
Professional Position: Board Certified Sleep Specialist 
4.4.1. Co-ordinating Investigator 
Name: Emily Palmisano 
Address: Ohio Sleep Medicine Institute, 4975 Bradenton Avenue, Dublin, Ohio 43017 
Email: emily@sleepmedicine.com  
Phone: 614-766-0773 
Professional Position: Clinical Trials Coordinator 
4.4.2. Co-ordinating Investigator 
Name: Kathy Datema 
Address: Ohio Sleep Medicine Institute, 4975 Bradenton Avenue, Dublin, Ohio 43017 
Email: kathy@sleepmedicine.com  
Phone: 614-766-0773 
Professional Position: Clinical Trials Coordinator 
 
 
 
Other Investigators 
Name: Irene Cheung 
Address: 15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand. 
Email: irene.cheung@fphcare.co.nz  
Phone: +64 9 5740123 Ext. 7889 
Professional Position: Clinical Research Scientist 
 
 
 
Institution 
Name: Clayton Sleep Institute  
Address: 2531 S. Big Bend Boulevard, St Louis, Missouri, 63143 
Phone: 314-645-6005 
Country of residence: United States of America 
 
Name: Alabama Sleep Clinic 
Address: 4810 Whitesport Circle, Suite 110, Huntsville, Alabama 35801 
Phone: 256-539-2531 

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Country of residence: United States of America 
 
Name: Central Florida Sleep Centre 
Address: 1121 N. Central Avenue, Kissimmee, FL 34741 
Phone: 407-624-4831 
Country of residence: United States of America 
 
Name: Ohio Sleep Medicine Institute 
Address: 4975 Bradenton Avenue, Dublin, Ohio 43017 
Phone: 614-766-0773 
Country of residence: United States of America 
 
5. 
Sponsor Information 
 
 
Primary Sponsor Details 
Name of Business: Fisher & Paykel Healthcare Limited 
Address: 15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand. 
Name of Sponsor contact person: Hanie Yee 
Phone: +64 9 5740123 Ext. 7909 
Email: Hanie.Yee@fphcare.co.nz 
Profession: Clinical Research Manager 
Country of residence: New Zealand 
 
6. 
Device Information 
 
Identification of the Medical Device 
The ICON 2 is a new platform of integrated humidifier Continuous Positive Airway Pressure (CPAP) 
devices. The intention of the new platform is to provide a more user friendly device which encourages 
acceptance and compliance with CPAP therapy. The device is still under development and will be 
manufactured for use for clinical investigation only. 
  
The investigational device will provide continuous positive airway pressure to the participant via a 
breathing tube and interface (mask). The device will be available in both a fixed CPAP mode and an 
AutoCPAP mode. The AutoCPAP mode will include software  which is able to automatically adjust the 
CPAP pressure to treat the patient as needed. The device will also have the options of three pressure 
comfort modes, which are available in existing CPAP devices: SensAwakeTM (which monitors the flow 
signal and lowers the pressure when the patient is awake), expiratory relief (which lowers the pressure 
on each breath exhalation) and ramp (which lowers the pressure when activated by the patient, and 
increases gradually over a set time period). The integrated humidifier of the device, using technologies 
as ThermoSmartTM and Ambient Tracking PlusTM, will provide humidified air to improve patient comfort 
(at a patient customizable setting) whilst minimizing condensation.   
 
The investigational device will provide usual therapy for the participants using their usual device 
settings. This device does not utilize tissue, substances or blood derivatives of human or animal origin. 
 
Data from the ICON 2 device is uploaded to a healthcare provider data management software – 
InfoSmart Web. InfoSmart Web is already a fully released product in the US.  
 
There is also a patient-facing mobile application that may be used by the patient as part of this trial 
(HealthZone mobile). This application enables patients to see their own sleep therapy data, and at the 

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same time upload their therapy data to InfoSmart Web, so it is viewable to the healthcare provider. The 
HealthZone mobile app will be available in a beta-release version on the Apple store, and can be 
downloaded by patients if they have an Apple device. Additional instructions will be made available to 
patients who wish to use this application, as a beta-released application is not publically viewable on 
the app store without a specific invitation.     
 
 
Device Risk Analysis and Management 
All investigational devices used in this clinical investigation will undergo device risk analysis and 
management prior to being released for clinical investigation. Evidence of the risk management process 
will be filed in the Clinical Investigation Folder (CIA-176).  
 
All contraindications, warnings, precautions and adverse effects of using this device are included in the 
device manuals, filed in CIA-176, Section 2.3 Investigator’s Brochure (IB) and all associated materials.  
 
Reporting of adverse events or adverse device effects will be included in the Clinical Investigation 
Folder (CIA-176), the site regulatory file and reported on the participant’s case report form (CRF).  
7. 
Justification for a Clinical Trial 
 
Synopsis 
Existing and Naïve CPAP users will be recruited into this 6 month study to evaluate the clinical 
performance of a new CPAP platform. Participants will attend 5 study visits in total at day 0, 7, 30, 60 
and 180. Outcomes of the clinical investigation include downloadable device data reports, device error 
reports and participant perception questionnaires. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
All data collected up to 2 months to be included in a review – 
at least 115 patients @ 2 months. All reports of faults or issues 
to be to be reported by 60 day 
Continuing analysis 
– not tied to device 
release 
Visit 1: Device setup  
Visit 2: 7 day follow-up  
Visit 3: 30 day follow-up  
Visit 4: 60 day follow-up  
Visit 5: 180 day follow-up  
Informed Consent and Demographics 
Perception questionnaire 
Fault reports 
InfoSmart report  
Flow data  
Fault reports 
Perception questionnaire 
In-home treatment 
In-home treatment 
In-home treatment 
In-home treatment 
End of study 
InfoSmart report  
Flow data  
Fault reports 
Perception questionnaire 
 
InfoSmart report  
Flow data  
Fault reports 
InfoSmart report  
Flow data  
Fault reports 

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* Some participants may be invited to attend an additional qualitative interview with a Fisher & Paykel 
Healthcare representative, to gather more detailed feedback regarding the ICON 2 device and its use. 
These interviews may occur at any point within the 6 month follow-up period.  
 
 
Literature Review 
Obstructive sleep apnea (OSA) is a prevalent health issue in western world effecting 24% of men and 
9% of women of the middle age population, and affecting around 2-4% of the total adult population 1, 2. 
It is characterized by periodic collapse of the upper airway during sleep. CPAP is the primary treatment 
for patients with OSA3,4. Despite the effectiveness of CPAP in abolishing upper airway obstruction, 
compliance with therapy has been sub-optimal5, 6. 
 
Conventional CPAP (i.e. fixed pressure) is generally higher than necessary for much of the night as the 
required CPAP pressure is selected on one night, and pressure requirements can vary considerably 
with sleeping posture, sleep stage and environmental influences such as alcohol and sedative use7,8. 
AutoCPAP addresses this problem by continually monitoring airflow changes and only increasing the 
pressure when the upper airway requires stabilization and reducing pressure at other times to make 
therapy more comfortable. Research suggests that AutoCPAP in general delivers a lower mean 
treatment pressure than conventional CPAP. Despite this, there is limited evidence to suggest that 
AutoCPAP therapy can considerably improve CPAP adherence and compliance9-15. The device under 
investigation can be set to operate as a conventional fixed pressure CPAP or as an AutoCPAP.  
 
The use of heated humidifier with CPAP has been shown to increase compliance16-17, even more so 
in non-compliers16. Ambient Tracking PlusTM and ThermoSmartTM are humidity delivery technologies 
that aim to provide the patient with physiological humidity (at the same level maintained by the 
nasopharynx), and adjusts to room temperature to prevent condensation. ThermoSmart is able to 
increase the patient comfort level to the patient compared with conventional humidification18. 
SensAwakeTM technology provides relief from pressure when a patient transitions from sleep to 
wake19. In order to improve performance and patient comfort, ICON 2 includes changes to the existing 
technologies of AutoCPAP, ThermoSmart, SensAwake and Ambient Tracking Plus, and the addition 
of expiratory relief, a pressure relief that reduces the pressure slightly when a patient exhales, which 
is commonly available in other brand CPAP devices. Each of these features will be available for use 
by participants in the trial, should they or their healthcare provider wish to use them.  
 
 
Preclinical Testing 
The investigational devices will undergo verification and validation testing, which will be reviewed in a 
“Design Review: Release for Clinical Investigation” to ensure that all risks have been assessed and 
mitigated appropriately prior to release of the devices for clinical investigation. These reviews will be 
referenced and included in the clinical investigation folder (CIA-176), under section 2.10 Justification of 
Device Safety.  
 
 
Previous Clinical Experience 
The ICON 2 device is similar to the existing devices FPH CPAP devices such as ICON and ICON+, but 
with mechanical and aesthetic design changes and improvements. ICON 2 provides the same intended 
therapy as other CPAP devices, whose safety and effectiveness is described in Section 7.2.  
 
This device has already undergone two rounds of In-Lab Assessment investigations in New Zealand, 
where the device was used by participants in the sleep lab for one night (CIA-100 ICON 2 In Lab 
Assessment and CIA-136 ICON 2 In Lab Assessment 2,  which were both registered on the ANZCTR 
trial registry and received HDEC NZ approval for clinical investigation). The conclusion of these 
investigations were that the ICON 2 device in both CPAP and APAP mode could treat OSA effectively, 
and that the technologies within performed as expected. In this investigation, the device will be used 
for an extended period of time in the participants’ home setting.  
 

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Justification for Administration 
The device, and all of the therapy and comfort settings to be used in this trial have been previously 
tested, and are expected to be at least as efficacious as previous versions. Any indications of reduced 
efficacy will be investigated as an outcome of this trial. Participants will receive treatment as prescribed, 
and so are likely to receive the same benefit as they would with another CPAP device, with the same 
expected therapy risks (as defined in Section 8.4).   
 
This need for this trial is to test the ICON 2 device in a larger population, through home-health care 
providers, with participants receiving treatment longer-term treatment in-home in order to replicate real 
life conditions. The treatment period of the clinical investigation is designed to assess the device failure 
rates, with most previous generation device failures occurring within the first 60-90 days of use. The 
additional follow-up period of 90 days is to account for additional/later failures with this device, which 
may not be represented by previous generation devices.    
 
8. 
Objectives of the Clinical Investigation 
 
 
Hypothesis 
The ICON 2 investigational device clinical performance will be acceptable in terms of product reliability, 
therapy effectiveness and user feedback.   
 
 
Objectives 
 
The primary objective for this investigation is to evaluate whether the investigational device treats the 
participant safely, effectively and reliably over a 6 month period of in-home treatment.  
 
Effectiveness will be determined by the AHI reported by the device, and additional flow data 
files.  
 
Safety will be determined by the log of safety-related events.  
 
Reliability will be determined from user-reported faults and the machine fault logs.  
 
The secondary outcome of this investigation is the participant perception of the device through the 
participant perception questionnaire, provided in Appendix A and B. Claims from the results of this 
questionnaire may be used for promotional material.  
 
 
Population 
This investigation will include a total of 150 adult participants (22 or older) with a diagnosis of OSA and 
a PAP (CPAP or AutoCPAP) prescription. They may be either experienced users of PAP or naïve to 
PAP therapy. Further details are included in Section 9.8 Inclusion/Exclusion Criteria.   
 
 
Risks 
Positive airway pressure therapy is considered to be the gold-standard therapy for individuals with OSA 
(Section 7.2). The treatment is considered to be extremely safe and any adverse effects are usually 
short term and easily resolvable. Adverse effects can be caused by an ill-fitting mask, too much or too 
little pressure being delivered to the participant, existing or developing nasal congestion during CPAP 
use. Individuals that are contraindicated for CPAP therapy will be excluded during screening. For more 
information on contraindications, warnings and precautions refer to the user manuals provided in CIA-
176, Section 2.3 Investigator’s Brochure and associated materials.  
 
The primary risk within the scope of this study that the pressure may be slightly too high or slightly too 
low due to poor device performance (either due to a fault within the device, or a poorly performing 

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AutoCPAP or pressure relief algorithm). In the case of the pressure being slightly too low (sub-
therapeutic), this may result in the participant having sleep disordered breathing events. If the pressure 
is too high, then the participant may be uncomfortable during CPAP use. Either of these may result in 
the participant feeling more tired than usual the next day. Other risks associated with poor device 
performance include poor humidity performance due to a fault within the device, or a poorly performing 
humidity algorithm which may result in side effects of CPAP related to nasal dryness and congestion. 
All of these risks are common to fully-released CPAP devices, and this study represents no greater risk 
than usual therapy.   
   
As this study is long-term (up to 6 months use), follow-up appointments at day 7, 30, 60 and 180 as 
well as therapy data monitoring and downloads can help identify participants receiving poor treatment, 
suffering from side effects, or struggling to use the investigation device. 
 
 
Essential Requirements of the Relevant Directive  
Essential requirements are not applicable since this study is being conducted in the US only. 
9. 
Clinical Investigation Design 
 
Type of Investigation 
This is an open-label (investigators and participants are un-blinded and informed of intended treatment 
device) single arm study. The intended treatment (CPAP or AutoCPAP) will not be randomized – as the 
intention is not to compare therapies. 
 
 
Controls 
No control group will be used in this study, as it is designed to test the performance and safety of the 
ICON 2 device and inform product development of any changes that need to be implemented before 
product release.  
 
 
Bias 
Participants will not be blinded to any therapy settings for the duration of the trial. They will be allowed 
to change humidity settings as per their preference. Device performance is objectively measured using 
device captured data. 
 
 
End Points 
9.4.1. Primary Outcomes 
The primary outcomes of effectiveness, safety and reliability will be measured by:  
 
Effectiveness will be determined by the AHI reported by the device, from device compliance 
and efficacy reports produced at day 7, 30, 60 and 180, and the flow data files from the 
device.  
 
Safety will be determined by the log of safety-related events from the CRFs at day 7, 30, 60 
and 180.  
 
Reliability will be determined from the machine fault logs from the CRF and device data files.  
 
9.4.2. Secondary Outcomes 
The secondary outcome of this investigation is the participant perception of the device (of the setup, 
use and cleaning of the device and its accessories) through the participant perception questionnaires 
at day 0, 7 and 30, provided in Appendix A and B  
 
 
Variables 
The following variables will be recorded during the investigation:  

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 
Participant variables: 
o Age 
o Gender 
o OSA severity 
o Any pre-existing co-morbidities (cardiac, HT etc.) 
o Participant ethnicity 
o Participant height/weight 
 
 
Usual participant therapy details: 
o Device details – Brand, model & type (Auto/Constant) 
o Device Pressure setting 
o Device Humidity setting 
o Participant interface type 
 
 
Measurements 
The following measurements will be performed during the study remotely and at follow-up appointments 
to evaluate the safety, efficacy and reliability of the ICON 2 device in the participant’s home setting. 
 
 
Device reported AHI, sleep time, system leaks, SensAwake arousals & other information. This 
information may be collected via: 
o direct download from the device USB (InfoUSB)  
o upload from the InfoUSB to a cloud-based system (InfoSmart Web)  
o bluetooth upload to the Healthzone mobile app which will also automatically upload onto 
InfoSmart Web.  
 
Accessing and downloading machine fault logs and flow data at every follow up appointment. 
This information may be collected via a direct download from the device USB (InfoUSB). 
 
Log of safety related events recording any safety issues with the investigational device. 
 
Patient perception questionnaire feedback 
 
 
Equipment 
Each participant will be issued the following: 
 
ICON 2 device, including 
o Device outlet elbow 
o Device inlet seal 
o Device humidity chamber 
o Device lid seal 
o Device air filter  
o Device breathing tube (may be heated or non-heated) 
o InfoUSB 
 
Patient User Instructions 
 
Device error log 
 
Access to InfoSmart Web 
 
Instructions to access HealthZone mobile application if a participant wishes to use it 
 
 
Inclusion / Exclusion criteria 
The inclusion criteria for participants in this investigation will be: 
 
Aged 22 and over (FDA defined as adult). 
 
Diagnosed with OSA by a practicing physician and prescribed PAP (CPAP or AutoCPAP) 
therapy. 

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 
For experienced users of PAP (CPAP or AutoCPAP): 
o Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification 
allowed by the investigator of each site if the participant does not meet this compliance 
but is deemed suitable for this trial). 
 
The exclusion criteria for participants in this investigation will be: 
 
Contraindicated for PAP (CPAP or AutoCPAP) therapy.  
 
Persons with other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, 
central sleep apnea). 
 
Persons with obesity hypoventilation syndrome or congestive heart failure. 
 
Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device. 
 
Persons with implanted electronic medical devices (e.g. cardiac pacemakers). 
 
Persons who are pregnant or think they might be pregnant.  
 
Persons whose is not fluent in spoken and written English.   
 
 
Point of Enrolment 
A participant shall be considered enrolled into the investigation once they have been screened for the 
inclusion/exclusion criteria, signed the informed consent form and taken the device home to use for the 
first time.  
 
 Patient Procedure 
Participants will undergo screening/recruitment through a phone call with a study coordinator. Once 
screened an appointment date and time will be set for their trial initiation interview, and a copy of the 
participant information sheet and informed consent will be sent to the patient to review.  
 
Visit 1 (Day 0): During this appointment lasting approximately 60 minutes, the inclusion/exclusion 
criteria will be checked again and the participant will undergo informed consent, where they will be 
given essential information about the investigation, trial device and have any questions answered. The 
participant’s mask condition will be checked at this visit and may have parts or the whole mask replaced 
by a new mask (fully released in US) as per their usual care. The trial device will have the appropriate 
device settings loaded (based on their current device settings, or those ordered by the physician 
prescription) and the participant will be shown how to use the device. The participant will be asked to 
complete a perception questionnaire to gather their first impressions of the device (Appendix A). The 
trial device will be issued to the participant to be used as their primary therapy device for their OSA for 
up to 6 months. 
 
A participant reimbursement of $30 will be provided on completion of  visit 1 to compensate the 
participant for their travel costs and time.  
 
Visit 2 (Day 7 ± 3 days): A follow up appointment will take place at day 7, lasting approximately 30 
minutes. The participant’s device will be checked by the healthcare provider, and any device 
faults/issues recorded. Device data will be downloaded using the usb data stick, and this data will be 
used to generate an InfoSmart report from Day 0 to the current date (reports the participant’s device 
usage and therapy efficacy), a fault log file and detailed flow-data. The participant will be asked to 
complete a 7 perception questionnaire (Appendix B).  
 
A participant reimbursement of $30 will be provided on completion of  visit 2 to compensate the 
participant for their travel costs and time.  
 
Visit 3 (Day 30 ± 3 days): A follow up appointment will take place at day 30 (± 3 days), lasting 
approximately 30 minutes. The participant’s device will be checked by the healthcare provider, and any 

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device faults/issues recorded. Device data will be downloaded using the usb data stick, and this data 
will be used to generate an InfoSmart report from Day 0 to the current date (reports the participant’s 
device usage and therapy efficacy), a fault log file and detailed flow-data. The participant will be asked 
to complete a perception questionnaire (Appendix B). 
 
A participant reimbursement of $30 will be provided on completion of visit 3 to compensate the 
participant for their travel costs and time.  
 
Visit 4 (Day 60 ± 3 days): A follow up appointment will take place at day 60 (± 3 days), lasting 
approximately 30 minutes. The participant’s device will be checked by the healthcare provider, and any 
device faults/issues recorded. Device data will be downloaded using the usb data stick, and this data 
will be used to generate an InfoSmart report from Day 0 to the current date (reports the participant’s 
device usage and therapy efficacy), a fault log file and detailed flow-data 
 
A participant reimbursement of $30 will be provided on completion of  visit 4 to compensate the 
participant for their travel costs and time.  
 
Visit 5 (Day 180 ± 7 days): The final follow up appointment will take place at day 180 (± 7 days), lasting 
approximately 30 minutes. The participant’s device will be checked by the healthcare provider, and any 
device faults/issues recorded. Device data will be downloaded using the usb data stick, and this data 
will be used to generate an InfoSmart report from Day 0 to the current date (reports the participant’s 
device usage and therapy efficacy), a fault log file and detailed flow-data. The device and all associated 
accessories will be returned to the healthcare provider, who will return it to FPH. Any issued masks or 
mask parts will not be required to be returned. 
 
A participant reimbursement of $30 will be provided on completion of  visit 5 to compensate the 
participant for their travel costs and time.  
 
Additional qualitative interview: A number of participants (up to 20 participants) will be invited to 
attend an additional qualitative interview with a Fisher & Paykel Healthcare representative, lasting up 
to 90 minutes, to get their detailed feedback on the ICON 2 device and its use. These interviews may 
take place at any point during the 6 month follow up period. Study sites will recruit these participants 
from the overall cohort, dependent on their ability and willingness to attend the interview.  
 
A participant reimbursement of $100 will be provided on completion of the qualitative interview to 
compensate for their travel costs and time.  
 
 Withdrawal Criteria 
Participants enrolled in this investigation will be notified that they have the right to withdraw from the 
investigation at any time, without prejudice to their medical care and are not obliged to state their 
reasons. The investigator will follow-up any withdrawals.  
 
Additionally, the investigator may withdraw a participant at any time for the following reasons: 
 
1. Inability to tolerate trial PAP device due to nasal obstruction or claustrophobia 
2. Protocol violation 
3. Serious illness 
4. Adverse events 
 
The reason for participant discontinuation in the investigation is to be recorded in the CRF and will be 
included in any clinical investigation report.  

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 Number of Trial Subjects 
150 trial participants will be included in this investigation, aiming for at least 50 of those participants 
being naïve to PAP (CPAP or AutoCPAP). Each participant will use their own trial device, and so 150 
devices are required. It is estimated that 30 days will be need to enroll these participants across 4 sites.  
 
The target for each site is: 
 
Clayton Sleep Institute – 70 participants 
 
Alabama Sleep Clinic – 30 participants 
 
Central Florida Sleep – 30 participants 
 
Ohio Sleep Medicine Institute – 20 participants.  
 
 Follow up Plan 
Follow-up appointments will be booked with the participants at day 7, 30, 60 and 180 during the 
investigation. For more information please see the patient procedure section 8.10.  
 
Participants remain under the medical care of their usual care provider during the trial, and after the 
trial has concluded.  
 
 Foreseeable Complications 
PAP (CPAP or AutoCPAP) use may irritate certain conditions and may be temporarily contraindicated 
in participants who exhibit sinus infection, middle ear infection or a perforated ear drum. Participants 
that are contraindicated for PAP (CPAP or AutoCPAP) will be excluded from the investigation.  
 
The participant will be instructed to cease using the device if they think the device is malfunctioning, 
not treating them or if they feel uncomfortable using the device; and that they should immediately 
swap to their usual PAP device (if available) for the rest of the night and contact a member of the 
research team as soon as possible. The research team will then assess with the participant if the 
problem can be resolved,  or withdraw them from the trial.  
10. 
Clinical Trial Documentation 
 Consent and Recruitment 
Informed consent will be taken for all participants enrolled in this investigation. A copy of the information 
sheet and consent form is included with the ethics application, filed in CIA-176 Section 2.6 Ethics 
application and subsequent approvals.   
 
 Case Report Form 
Investigation data will be recorded in source documents and attached to the Case Report Form (CRF) 
for both the administration of the investigation and collection of participant data. A master index will 
contain confidential participant contact information and will be the only link between individual 
participants and the ID number. A copy of the blank case report form is included in section 3.03 of the 
CIA-176 folder and also in the similar labelled folder electronically. 
 
10.2.1. Case Report Form Signatories 
Case Report Form Signatories will be included on the Delegation of Authority in the site regulatory 
file. 
 
 Insurance Statement 
A copy of the insurance statement will be included in the CIA folder (CIA-176) under section 2.8 
Insurance Certificates and Indemnity Agreements, and in the site regulatory file.  

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 Record of Deviations  
There are currently no deviations to the clinical investigation plan (CIP).  
STATISTICAL CONSIDERATIONS 
 Description of the Statistical Design 
The total sample size across three clinical investigations (USA (this study), New Zealand and Australia) 
has been chosen at 230 devices (1 device per participant).   
 
230 devices is based upon a binomial model of 90% confidence and 99% reliability, allowing for no 
critical failures in the sample. Refer to 10.7 Pass/Fail criteria for description and classification of failures.  
 
 Sample Size 
150 participants will be required as part of this pre-release assessment in the USA.  
 
A minimum number of compliance data reports must be reviewed for the presence of algorithm issues 
(related to effective treatment), data corruption affecting compliance reprint and any other anomalies: 
 
120 of 7 day reports (80% of recruited patients) 
 
120 of 30 day reports (80% of recruited patients) 
 
75 of 60 day reports (50% of recruited patients) 
 
The results from this clinical investigation will be incorporated into analysis with pre-release 
assessments in New Zealand (30 participants) and Australia (50 participants). 
 
 Pass/Fail Criteria 
The pass/fail criteria of this trial is related to the evaluation of the data to determine whether the ICON 
2 device can be released to the general market, after evaluation of data at the 60-day follow-up point.  
 
A device failure will be classified as:  
 
Any failures that leads to a patient harm – as determined through reported adverse 
events/adverse device effects.    
 
Loss or degradation of primary function – as determined through error reports. This includes 
failure to deliver therapeutic pressure (i.e. stops working, or delivers sub-optimal pressure) and 
failure of the humidity system (i.e. heater plate stops working).  
 
Loss of secondary function – as determined through error reports. This includes failure to access 
patient data.  
 
User dissatisfaction/inconvenience.  
 
All device failures will be reviewed by a review board, including representatives from product 
development, quality, regulatory affairs, clinical and marketing.  
 
Critical failures are any failures that lead to a catastrophic, serious or moderate harm and will 
be classified as unacceptable, requiring design changes/mitigations before the ICON 2 is 
released to market.  
o Catastrophic harms are defined as those that lead to death.  
o Serious harms are defined as an injury or impairment that is life threatening, results in 
permanent impairment of a body function or permanent damage to a body structure, or 
necessitates a medical or surgical intervention to preclude a permanent impairment.  
o Moderate harms are defined as an injury or impairment requiring professional medical 
intervention, excluding what is defined as a serious injury.   

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 
All other failures will be reviewed against to determine their acceptability under internal company 
risk assessment procedures, using both the severity of the failure, and the number of failures 
that occurred within the trial, to determine if design changes/mitigations are required before 
general release. These may include minor or negligible safety harms (including short term OSA 
symptoms, patient discomfort) and loss or degradation of intended functions or user 
dissatisfaction/inconvenience.  
 
 Statistical Termination 
There is no criteria for statistical termination for this investigation.  
 
 Statistical Procedure Deviations 
There is no criteria for statistical procedure deviations for this investigation.  
 
 Selection Criteria 
All enrolled subjects will be included in the analysis at the review board meeting, The review meeting 
will not be held until at least the minimum number of reports for each compliance period has been met, 
and all recruited patients have passed the 60 day time point.  
 
All available compliance reports will be included at the date at which the review board meeting 
is held.  
 
All available feedback questionnaires will be included at the date at which the review board 
meeting is held. 
 
All available error reports will be included at the date at which the review board meeting is held. 
 
 Statistical Data Management 
Compliance and efficacy reports will be collected via InfoSmart Web software, and confirmed as 
collected by the investigator. Incomplete reports and/or missing data from within a report will be 
classified as a report anomaly and investigated further.  
 
Patient feedback questionnaires will be completed online via an online questionnaire application. All 
received responses will be reviewed, including partially completed questionnaires. Missing answers or 
unclear answers will be excluded from analysis (neither viewed positively or negatively).  
 
Error reports will be collected via an error log (for errors detected by the patient/healthcare provider) 
and via the device download data to be interrogated by software engineers. All errors will be logged 
and investigated.  
 
11. 
Adverse Events and Termination 
 Emergency Contact Details 
The participant will contact their following investigator if there are any adverse events: 
Name: Matt Uhles 
Address: Clayton Sleep Institute, 2531 S. Big Bend Boulevard, St Louis, Missouri, 63143 
Email: uhlesm@claytonsleep.com 
Phone: 314-645-6005 
 
Investigator: Edward M.Turpin, MD 
Address: Alabama Sleep Clinic, 4810 Whitesport Circle, Suite 110, Huntsville, Alabama 35801 
Email: ETurpinMD@alabamasleepclinic.com 
Phone: 256-539-2531 
 

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Investigator: Thomas W. O’Brien, MD 
Address: Central Florida Sleep Centre, 1121 N. Central Avenue, Kissimmee, FL 34741 
Email: pi@PDS-CFSC.com  
Phone: 407-624-4831 
 
Investigator: Asim Roy, MD 
Address: Ohio Sleep Medicine Institute, 4975 Bradenton Avenue, Dublin, Ohio 43017 
Email: aroy@sleepmedicine.com  
Phone: 614-766-0773 
 
 Foreseeable Adverse Events 
Foreseeable adverse events for this investigation include the following: 
 
 
Feeling of uneasiness and/or discomfort with a pressure delivered that is too high.  
 
Tiredness, daytime sleepiness with a pressure delivered that is too high or too low. 
 
An ill-fitting mask with high system leak can cause sub-optimal therapy being delivered to the 
participant, which can cause daytime sleepiness and tiredness. 
 
Nasal drying/discomfort due to PAP, which may be ameliorated by the humidification system in 
the device.   
 
These foreseeable adverse events are the same as those for a PAP patient on their usual therapy.  
 
 Reporting Adverse Events 
Adverse events will be recorded on the Case Report Form (CRF) and the investigator of each site will 
be notified of all adverse events. Serious adverse events will be reported to the sponsor and relevant 
authority within 24 hours.   
 
Name: Irene Cheung 
Address: 15 Maurice Paykel Place 
Phone: +64 09 5740123 Ext. 7889 
Email: irene.cheung@fphcare.co.nz 
 
Name: Hanie Yee 
Address: 15 Maurice Paykel Place 
Phone: +64 09 5740123 Ext. 7909 
Email: Hanie.Yee@fphcare.co.nz 
  
 Early Termination 
If a participant is struggling with therapy during the investigation and we are unable to resolve the issue 
causing the problem, the participant may be terminated early from the investigation. The participant 
also has the right to withdraw from the investigation at any point without a need for a reason.  
 
If through error reports and adverse events it becomes clear that the ICON 2 device is not treating 
participants effectively, the investigator may terminate the trial in its entirety.  
 
The following documentation is required if the appropriate party terminates a clinical trial. 
11.4.1. Investigator 
If the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator 
should inform the institution, where required by the applicable regulatory requirements and the 

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investigator/institution should promptly inform the sponsor and the IRB, and should provide the sponsor 
and the IRB a detailed written explanation of the termination or suspension.  
 
11.4.2. Sponsor 
If the sponsor terminates or suspends a trial, the investigator should promptly inform the institution, 
where required by the applicable regulatory requirements, and the investigator/institution should 
promptly inform the IRB and provide the IRB a detailed written explanation of the termination or 
suspension. 
 
11.4.3. Institutional Review Board (IRB)  
If the IRB terminates or suspends its approval/favorable opinion of a trial the investigator should inform 
the institution, where required by the applicable regulatory requirements, and the investigator/institution 
should promptly notify the sponsor and provide the sponsor with a detailed written explanation of the 
termination or suspension. 
12. 
Publication Policy 
The results from this investigation will not be published externally to any journal or other source. The 
results from this investigation will feed into product development and will help implement any changes 
if needed to the final product before release. Results from this investigation may be used for marketing 
of the released product (i.e. results from the participant perception questionnaires) – but these will only 
be published in a completely de-identified way. 
13. 
Approval  
Signing the below approval indicates that the principal investigator(s) (PI) in each trial center and the 
sponsor agree to this version of Clinical Investigator Plan. 
 
Principal Investigator Approval:  
PI Name:  
 
 
 
 
_______________________________________ 
PI Signature:   
 
 
 
_______________________________________ 
Date (dd/mmm/yyy):   
 
 
_______________________________________ 
 
Sponsor Approval  
Sponsor Name:  
 
 
 
_______________________________________ 
Sponsor Signature:   
 
 
_______________________________________ 
Date (dd/mmm/yyy):   
 
 
_______________________________________ 
14. 
References 
1. Diamanti, C., E. Manali, M. Ginieri-Coccossis, K. Vougas, K. Cholidou, E. Markozannes, P. 
Bakakos, I. Liappas and M. Alchanatis. "Depression, Physical Activity, Energy Consumption, and 
Quality of Life in Osa Patients before and after Cpap Treatment." Sleep Breath,  (2013). 
2. Vanderveken, O. M., A. Boudewyns, Q. Ni, B. Kashyap, J. Verbraecken, W. De Backer and P. 
Van de Heyning. "Cardiovascular Implications in the Treatment of Obstructive Sleep Apnea." J 
CardiovascTransl Res 4, no. 1 (2011): 53-60. 
3. Sullivan, C., F. Issa, and M. Berthon-Jones, Reversal of obstructive sleep apnoea by continuous 
positive airway pressure applied through the nares. Lancet, 1981. 1: p. 862-865. 
4. Gay, P., et al., Evaluation of positive airway pressure treatment for sleep related breathing 
disorders in adults. Sleep, 2006. 29: p. 381-401. 
5. Weaver, T., et al., Night-to-night variability in CPAP use by patients with obstructive sleep apnea. 
Sleep, 1997. 20: p. 278-283. 

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6. Kribbs, N.B., et al., Objective measurement of patterns of nasal CPAP use by patients with 
obstructive sleep apnea. Am Rev Respir Dis, 1993. 147(4): p. 887-95. 
7. Berry, R.B., J. Parish, and K. Hartse, The use of auto-titrating continous positive airway pressure 
for treatment of adult obstructive sleep apnea. Sleep, 2002. 25(2): p. 148-173. 
8. Oskenberg, A., et al., The sleep supine position has a major effect on optimal nasal continuous 
positive airway pressure; relationship with rapid eye movement and non-rapid eye movements 
sleep, body mass index, respiratory disturbance index, and age. Chest, 1999. 116: p. 1000-1006. 
9. Ayas, N.T., et al., Auto-titrating versus standard continuous positive airway pressure for the 
treatment of obstructive sleep apnea: results of a meta-analysis. Sleep, 2004. 27(2): p. 249-53. 
10. Behbehani, K., et al., A sleep laboratory evaluation of an automatic positive airway pressure system 
for treatment of obstructive sleep apnea. Sleep, 1998. 21(5): p. 485-91. 
11. Boudewyns, A., et al., Two months follow up of auto-CPAP treatment in patients with obstructive 
sleep apnoea. Thorax, 1999. 54(2): p. 147-9. 
12. d'Ortho, M.P., Auto-titrating continuous positive airway pressure for treating adult patients with sleep 
apnea syndrome. CurrOpinPulm Med, 2004. 10(6): p. 495-9. 
13. d'Ortho, M.P., et al., Constant vs. automatic continuous positive airway pressure therapy: home 
evaluation. Chest, 2000. 118(4): p. 1010-7. 
14. Randerath, W.J., et al., eds. Autoadjusting CPAP therapy based on impedance efficacy, compliance 
and acceptance. Am J RespirCrit Care Med. Vol. 163. 2001. 652-7. 
15. Teschler, H., et al., Automated continuous positive airway pressure titration for obstructive sleep 
apnea syndrome. Am J RespirCrit Care Med, 1996. 154(3 Pt 1): p. 734-40. 
16. Rakotonanahary, D., et al., Predictive Factors for Need for Additional Humidification During Nasal 
Continuous Positive Airway Pressure Therapy. CHEST, 2001 119(2):460-5. 
17. Massie C.A., et al., Effects of Humidification on Nasal Symptoms and Compliance in Sleep Apnea 
Patients Using Continuous Positive Airway Pressure. Chest, 1999 116(2): 403-8. 
18. Almasri E., et al., Heated Wall Tubing Provides More Humidity and Comfort than Standard CPAP 
units with Heated Humidifiers. Sleep, 2007 30:A190. 
19. Powell E.D., et al., Long-term patient feedback on a novel automatic ramp feature in fixed 
pressure CPAP. World Association of Sleep Medicine Conference 2011[poster]: T-1-054.  
 
 

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15. 
Appendix A: Initial Impression Questionnaire 
 
 

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16. 
Appendix B: Perception Questionnaire