The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: Fisher and Paykel Healthcare



Created using TMP-51_c – Parent Procedure SP-290 
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CONFIDENTIAL.  Fisher & Paykel Healthcare internal use only 
 
 
 
 
 
 
Clinical Investigation Plan  
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
  
 
 
 
 

                               
 
 
 
 
 
 
 
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Table of Contents 
1. 
Revision History ....................................................................................................................... 5 
1.1. List of Abbreviations ...................................................................................................... 5 
2. 
Document Information .............................................................................................................. 6 
2.1. Purpose and Scope ....................................................................................................... 6 
2.2. Confidentiality Statement .............................................................................................. 6 
2.3. Persons Authorized to Amend the CIP ........................... Error! Bookmark not defined. 
2.4. Monitoring Arrangements .............................................................................................. 6 
2.5. Data Management ......................................................................................................... 7 
3. 
Investigator Information ........................................................................................................... 7 
3.1. Principal Investigator ..................................................................................................... 7 
3.2. Coordinating Investigator .............................................................................................. 7 
3.3. Other Investigators ......................................................... Error! Bookmark not defined. 
3.4. Institution....................................................................................................................... 8 
4. 
Sponsor Information ................................................................................................................. 8 
4.1. Primary Sponsor Details ................................................................................................ 8 
4.2. Overseas Representative ............................................... Error! Bookmark not defined. 
5. 
Device Information.................................................................................................................... 9 
5.1. Identification of the Medical Device ............................................................................... 9 
5.2. Device Risk Analysis and Management ........................................................................ 9 
6. 
Justification for a Clinical Trial .............................................................................................. 10 
6.1. Synopsis ..................................................................................................................... 10 
6.2. Literature Review ........................................................................................................ 11 
6.3. Preclinical Testing ....................................................................................................... 11 
6.4. Previous Clinical Experience ....................................................................................... 11 
6.5. Justification for Administration ..................................................................................... 12 
7. 
Objectives of the Clinical Investigation ................................................................................. 12 
7.1. Hypothesis .................................................................................................................. 12 
7.2. Objectives ................................................................................................................... 12 
7.3. Population ................................................................................................................... 12 
7.4. Risks ........................................................................................................................... 13 
7.5. Essential Requirements of the Relevant Directive ....................................................... 13 
8. 
Clinical Investigation Design .................................................... Error! Bookmark not defined. 
8.1. Type of Investigation ................................................................................................... 13 
8.2. Controls ...................................................................................................................... 14 
8.3. Bias ............................................................................................................................. 14 
8.4. End Points ................................................................................................................... 14 
8.4.1. Primary Outcome .................................................................................................................... 14 
8.4.2. Secondary Outcomes ............................................................................................................. 14 

                               
 
 
 
 
 
 
 
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8.5. Variables ..................................................................................................................... 14 
8.6. Measurements ............................................................................................................ 15 
8.7. Equipment ................................................................................................................... 17 
8.8. Inclusion / Exclusion criteria ........................................................................................ 17 
8.9. Point of Enrolment ....................................................................................................... 18 
8.10. Patient Procedure ....................................................................................................... 18 
8.11. Withdrawal Criteria ...................................................................................................... 25 
8.12. Number of Trial Subjects ............................................................................................. 25 
8.13. Follow up Plan ............................................................................................................ 25 
8.14. Foreseeable Complications ......................................................................................... 26 
9. 
Clinical Trial Documentation ..................................................... Error! Bookmark not defined. 
9.1. Consent and Recruitment ............................................... Error! Bookmark not defined. 
9.2. Case Report Form .......................................................... Error! Bookmark not defined. 
9.2.1. Case Report Form Signatories ................................................ Error! Bookmark not defined. 
9.3. Insurance Statement ...................................................... Error! Bookmark not defined. 
9.4. Record of Deviations ...................................................... Error! Bookmark not defined. 
STATISTICAL CONSIDERATIONS ............................................................................................................ 26 
9.5. Description of the Statistical Design ............................................................................ 26 
9.6. Sample Size ................................................................................................................ 27 
9.7. Pass/Fail Criteria ............................................................ Error! Bookmark not defined. 
9.8. Statistical Termination ................................................................................................. 28 
9.9. Statistical Procedure Deviations .................................................................................. 28 
9.10. Selection Criteria ......................................................................................................... 28 
9.11. Statistical Data Management....................................................................................... 28 
10. 
Adverse Events and Termination .......................................................................................... 28 
10.1. Emergency Contact Details ......................................................................................... 28 
10.2. Foreseeable Adverse Events ...................................................................................... 29 
10.3. Reporting Adverse Events ........................................................................................... 29 
10.4. Early Termination ........................................................................................................ 30 
10.4.1. 
Investigator ......................................................................................................................... 30 
10.4.2. 
Sponsor .............................................................................................................................. 30 
10.4.3. 
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) ........................ 30 
11. 
Publication Policy ................................................................................................................... 30 
12. 
Approval .................................................................................................................................. 30 
13. 
References .............................................................................................................................. 32 
14. 
Appendix A: Recruitment Script ............................................... Error! Bookmark not defined. 
Detailed Information for each Visit (if requested). ........................ Error! Bookmark not defined. 
15. 
Appendix B: Participant Questionnaire .................................... Error! Bookmark not defined. 
16. 
Appendix C: Participant Sleep Diary ........................................ Error! Bookmark not defined. 

                               
 
 
 
 
 
 
 
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17. 
Appendix D: Researcher Questionnaire ................................... Error! Bookmark not defined. 
 
 
1. 
Revision History 
Revision 
 
Date 
  
 
 
 
 
 
 
 
 
 
 
A 
11 June 2019 
B 
10 July 2019 
C 
17 
October 
2019 
 
1.1. 
List of Abbreviations 
AE 
 
Adverse Event 
AHI 
 
Apnea Hypopnea Index 
APAP  
Automatic Positive Airway Pressure 
BPAP  
Bi-Level Positive Airway Pressure 
 
CIA 
 
Clinical Investigation Administration 
CIP 
 
Clinical Investigation Plan 
CPAP  
Continuous Positive Airway Pressure 
CRF 
 
Case Report Form 
CSI 
 
Clayton Sleep Institute 
F&P 
 
Fisher & Paykel Healthcare 
GCP 
 
Good Clinical Practice 
HA 
 
Hazard Analysis 
IB 
 
Investigators Brochure 
ICF 
 
Informed Consent Form 
ICH 
International 
Conference 
on 
Harmonization 
of 
Technical 
Requirements 
for  
Registration of Pharmaceuticals for Human Use 
IRB 
 
Independent Review Board 

                               
 
 
 
 
 
 
 
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OSA 
Obstructive Sleep Apnea 
PAP 
 
Positive Airway Pressure 
SAE 
Serious Adverse Event 
SME 
 
Subject Matter Expert 
UI 
 
User Instructions 
2. 
Document Information 
2.1. 
Purpose and Scope 
The purpose of the trial is to evaluate the performance, comfort and ease of use (usability) of the F&P 
Nasal mask in the home environment in regards to satisfaction.  
 
2.2. 
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. 
2.3. 
  
• 
  
• 
  
• 
  
2.4. 
Monitoring Arrangements 
F&P will be conducting the study, and as such the investigators will monitor the progress of the 
investigation. Planned monitoring activities will take place at Visit 1, 2 and 3 by a F&P Clinical 
Researcher as well as once during the course of the study extension as outlined below: 
 
 
 
 
 
 
 
 
 
 
 
 

                               
 
 
 
 
 
 
 
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The principal investigator will have access to all source documents needed to verify the entries on the 
Case Report Forms (CRF) and other protocol- related documents; provided that participant 
confidentiality is maintained in agreement with local regulations. It will be the principal investigator’s 
responsibility to inspect the CRF at regular intervals throughout the investigation, to verify the 
adherence to the protocol and the completeness, consistency and accuracy of the data being entered 
on them.  
The investigator’s file will contain the protocol/amendments, financial disclosure form, CRFs, data 
clarification and query forms, Independent Review Board (IRB) approval with correspondence, 
informed consent, staff curriculum vitae and authorization forms, screening and enrolment logs, and 
other appropriate documents/correspondence as per International Conference on Harmonization 
(ICH) and Good Clinical Practice (GCP) and local regulations. 
 
2.5. 
Data Management  
Data obtained for this investigation will be recorded in source documents and attached to the CRF for 
both the administration of the study and collection of participant data. 
 
Original CRFs will be stored for 15 years by Fisher & Paykel Healthcare. Original Informed Consent 
Forms and copies of the CRF will be stored on site at Clayton Sleep Institute (CSI) for 15 years. 
3. 
Investigator Information 
 
3.1. 
Principal Investigator 
Name: Mark Muehlbach 
Address: 2531 S Big Bend Blvd, Maplewood, MO 63143, USA 
Phone: 314-645-5855 
Professional Position: Clinical Director 
 
3.2. 
Coordinating Investigator 
Name: Mr. Matthew Lee Uhles 
Address: 2531 S Big Bend Blvd, Maplewood, MO 63143, USA 
Email: uhlesm@claytonsleep.com 
Phone: 314-645-5855 Ext 318 
Professional Position: Chief Operating Officer 
 
 

                               
 
 
 
 
 
 
 
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3.3. 
  
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
3.4. 
Institution 
Name: Clayton Sleep Institute 
Address: 2531 S Big Bend Blvd, Maplewood, MO 63143, USA  
Email: uhlesm@claytonsleep.com 
Phone: 314-645-5855 
Country of residence: United States of America  
4. 
Sponsor Information 
4.1. 
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: Bhavi Ogra 
Phone: +64 9 574 0123 Ext 7882 
Email: bhavi.ogra@fphcare.co.nz  
Profession: Clinical Research Manager 
Country of residence: New Zealand 

                               
 
 
 
 
 
 
 
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4.2. 
 
 
 
 
 
 
 
 
5. 
Device Information 
5.1. 
Identification of the Medical Device 
The F&P Nasal is a nasal mask which is primarily used in combination with a Positive Airway 
Pressure (PAP) therapy device to administer PAP therapy either in a patient’s home or in the hospital.  
 
 
 
 
 
  
 
5.2. 
Device Risk Analysis and Management 
The acceptability of the risk associated with the device is derived from the benefit associated with 
positive airway pressure (PAP) therapy via a nasal mask for patients with OSA, and the generally 
accepted state of the art (currently and generally accepted as standard. CPAP flow generators, PAP 
therapy masks and info technology share the same risk acceptability criteria because they all provide 
the same overall benefit and the general accepted state of the art is close enough for the criteria to be 
shared.  
 
The primary benefit of PAP therapy is the treatment of OSA to reduce disease severity (as measured 
by the AHI) and improve daytime sleepiness and fatigue. Good evidence has accumulated that 
effective CPAP improves the neurobehavioral and cardiovascular consequences of OSA1,2. PAP 
therapy is the gold standard treatment for OSA and the benefits of treatment have been clearly shown 
to outweigh any risks of treatment in the OSA population                                                                . 
 
  
 

                               
 
 
 
 
 
 
 
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6. 
Justification for a Clinical Trial 
6.1. 
Synopsis 
The investigation is a prospective, non-randomized, non-blinded study. This investigation is designed 
to evaluate the performance (leak and comfort) as well as participant’s overall acceptance of the F&P 
Nasal mask amongst participants with diagnosed OSA. A minimum of 45 participants with OSA 
currently using a nasal, sub-nasal and/or pillows mask will be recruited by CSI. The phone recruitment 
script is available in Appendix A. CSI will recruit all participants within three weeks of beginning of the 
study. 
 
This study will involve a baseline visit (Visit 1) where participants’ informed consent for the F&P Nasal 
mask trial (CIA-262) will be gained. The participant’s prescribed PAP therapy treatment settings will 
be gathered as well. Participants will also fill out a questionnaire (Appendix B) to gain a better 
understanding of their satisfaction of their current mask.  
 
Visit 2 will take place 7 ± 3 days after Visit 1. At this visit, participants will be fitted with the F&P Nasal 
mask and will be asked a few questions in the form of a structured questionnaire. Initial impressions, 
comments and photographs will be captured via recorded audio and video (provided the participant 
has given consent). If the participant does not provide video and/or audio consent, only written notes 
will be taken. Baseline efficacy data will be downloaded from participants’ PAP/BPAP therapy 
devices. Participants will also be issued a sleep diary (Appendix C) to record daily feedback of the 
Nasal mask.  
 
A follow up phone call will be made by CSI 3±1 days after Visit 2 and feedback will be recorded in the 
CRF.   
 
Visit 3 will take place 14 ± 3 days after Visit 2. The participants will return to the site and provide their 
feedback on the F&P Nasal mask in the form of verbal comments and a structured questionnaire 
(Appendix B and D). Photographs will be captured as well as audio and video will be recorded during 
this visit (provided the participant has given consent). If the participant does not provide audio and/or 
video consent, only written notes will be taken. F&P Nasal efficacy data will be downloaded from 
participants’ PAP/BPAP therapy devices.  If the participant prefers their usual mask over the F&P 
Nasal mask, they will return the F&P Nasal mask and the User Instruction (UI) and return to using 
their usual mask and will be considered to have completed the investigation.  
 
If the participants prefer the F&P Nasal mask to their usual mask they will be invited to continue to 
use the F&P Nasal mask in-home for an additional 6 months. Monthly phone calls will be made and 
recorded in the CRF and at the end of six months the participants will be asked to return the mask 
and UI to CSI and provide their feedback in the form of verbal comments and a structured 
questionnaire (Appendix B). This will mark the 4th Visit and end of the extension part of the trial. 
Participants will return the F&P Nasal mask, and continue using their usual mask.  
 
This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from the protocol 
will be implemented without the prior review and approval of the sponsor except where it may be 

                               
 
 
 
 
 
 
 
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necessary to eliminate an immediate hazard to a research participant.  In such case, the deviation will 
be reported to the sponsor as soon as possible. 
 
 
6.2. 
Literature Review 
Obstructive Sleep Apnea (OSA) is a common sleep breathing disorder ranging from 9% to 38% in the 
general adult population3 and is characterized by periodic collapse of the upper airway during sleep.  
The standard treatment for obstructive sleep apnea is PAP, which consists of pressurized air applied 
to the nose via an interface. PAP includes continuous positive airway pressure (CPAP), automatic 
positive airway pressure (APAP) and Bilevel positive airway pressure (BPAP). Despite the 
effectiveness of PAP in abolishing upper airway obstruction, acceptance of and adherence with 
therapy has been sub-optimal4,5. Reasons for the low compliance include nocturnal awakenings, 
incorrect therapeutic pressure and primarily discomfort due to poor mask fit. Poor mask fit can result 
in facial abrasion, leak causing fluctuations in therapeutic pressure and irritation of the eyes6,7. 
 
 
 
 
 
6.3. 
  
 
 
 
 
 
6.4. 
  
 
 
 
 
 
 
 
 
 
 

                               
 
 
 
 
 
 
 
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6.5. 
Justification for Administration 
Participants will remain on their prescribed PAP /BPAP therapy pressures and devices during the 
duration of the trial. Baseline PAP /BPAP therapy data on the participant’s usual mask will be 
collected after 7 ± 3 days in order to evaluate treatment efficacy compared to the investigational 
mask. Participants will not be randomised to use the F&P Nasal in-home for 14 ± 3 days. 
7. 
Objectives of the Clinical Investigation 
7.1. 
Hypothesis 
 
 
 
7.2. 
Objectives 
Primary Objective:  
- 
To evaluate the performance, comfort and ease of use (usability) of the F&P Nasal mask in a 
home environment in regards to the participants’ view on overall comfort, overall experience 
and satisfaction. 
 
Secondary Objective: 
- 
To evaluate the performance, comfort and ease of use (usability) of the F&P Nasal mask in a 
home environment in regards to the participants’ view on overall comfort, overall experience 
and satisfaction over time.  
 
7.3. 
Population 
This investigation is a prospective, randomized, non-blinded study. This investigation is designed to 
evaluate the performance, comfort and ease of use of the F&P Nasal mask amongst a minimum of 45 
participants diagnosed with OSA who are current nasal, sub-nasal or pillows users. 
 

                               
 
 
 
 
 
 
 
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• 
  
• 
  
• 
  
 
• 
  
• 
  
• 
  
7.4. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.5. 
  
 
 
7.6. 
Type of Investigation 
This is an open-label (investigators and participants are non-blinded and informed of intended 
treatment device) single arm study. The F&P Nasal will provide effective treatment similar to the 

                               
 
 
 
 
 
 
 
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17 October 2019 
participant’s usual CPAP mask. The intended treatment F&P Nasal will not be randomized – as the 
intention is not to compare between masks therapies. 
 
7.7. 
Controls 
The PAP/BPAP therapy device data gathered from the participants using their usual mask at baseline 
will act as the control for each participant, and will be compared to the data gathered from participants 
when using the F&P Nasal mask. 
 
7.8. 
Bias 
The F&P Nasal mask is non-blinded and distinguishable. Since the trial mask is the same for the 
entire population, this study is not blinded. 
 
7.9. 
End Points 
7.9.1. Primary Outcome 
- 
The F&P Nasal mask provides adequate therapy for OSA during in-home use.  
 
7.9.2. Secondary Outcomes 
- 
The F&P Nasal mask is rated easy to use by the participant.  
- 
The F&P Nasal mask is rated as comfortable to use by the participant.  
- 
The F&P Nasal mask is rated overall by the participant as satisfactory.  
 
7.10. Variables 
Variable 
Justification 
 
Ease 
of 
use/Acceptability 
To assess the ease of 
using the mask in the 
home and overall mask 
acceptability 
Mask Comfort 
To assess the comfort 
(or lack of) of the mask 
as experienced by the 
participant while using it 
in-home.  
Usability 
of 
the 
mask 
To evaluate the usability 
of the mask through a 
custom designed ease of 
use usability script 
General 
Demographics 
To gather participants 
general demographics  
Preference   
To assess which mask 

                               
 
 
 
 
 
 
 
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17 October 2019 
the participants prefers 
to use going forward. 
Mask 
performance 
To assess the mask’s 
performance in relation 
to leak   
 
7.11.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
  
  
 
 
 
 
 

                               
 
 
 
 
 
 
 
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7.12. Equipment 
Participants will use their own PAP/BPAP therapy devices with their prescribed pressures.  
 
 
  
 
7.13. Inclusion / Exclusion criteria 
Inclusion Criteria  
• 
Diagnosis of OSA by Physician  
• 
≥ 22 years of age 
• 
≥ 66 lbs 
• 
Prescribed PAP or BPAP therapy for OSA 
• 
Existing nasal, sub-nasal and pillows mask users for approximately three months prior 
to enrollment in this investigation 
• 
Fluent in written and spoken English 
 
Exclusion Criteria 
• 
Inability to give informed consent 
• 
Pregnant or think they may be pregnant 
• 
PAP Intolerant 
• 
Anatomical or Physiological Conditions that make PAP therapy inappropriate 

                               
 
 
 
 
 
 
 
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• 
Participant’s PAP/Bi-level device without efficacy data recording capabilities 
• 
IPAP pressure of >25cmH20 
• 
PAP/BPAP therapy device usage for delivery of medicines with exception of oxygen 
 
7.14. Point of Enrolment 
Participants will be recruited from patients who are prescribed either APAP, CPAP or BPAP devices 
for OSA therapy at Clayton Sleep Institute. The principal investigator (or those identified in delegation 
log) will ask the subjects whether they’re interested to take part in the trial. The participants who 
provide informed consent and meet the inclusion/exclusion criteria will then be enrolled into the trial.   
 
7.15. Patient Procedure 
The study coordinator will ask the subjects whether they’re interested to take part in the trial. Only 
eligible participants, that provide written informed consent, will be enrolled into the investigation.  
 
 
EVENTS 
 
 
Visit 
One 
 
 
Visit 
Two   
 
 
Phone 
Call  
 
 
Visit 
Three 
 
Phone 
call 
Phone 
call 
Phone 
call 
Phone 
call 
Phone 
call 
Visit 
Four 
Informed consent 
(CIA-262) 
X 
 
 
 
 
 
 
 
 
 
Commence baseline 
data gathering 
X 
 
 
 
 
 
 
 
 
 
Participant 
Questionnaire (see 
Appendix B) 
X 
X 
 
 
 
 
 
 
 
 
Mask fitting with 
F&P Nasal mask 
 
X 
 
 
 
 
 
 
 
 
Static Leak 
Measurement 
 
X 
 
 
 
 
 
 
 
 
Issue complete 
Nasal 
mask with UI 
 
X 
 
 
 
 
 
 
 
 
Sleep Diary Issued 
 
X 
 
 
 
 
 
 
 
 
Researcher 
Questionnaire (see 
Appendix C) 
 
X 
 
X 
 
 
 
 
 
 
Baseline PAP 
device data 
downloaded 
 
X 
 
 
 
 
 
 
 
 
Commence in-home 
trial of the F&P 
 
X 
 
 
 
 
 
 
 
 

                               
 
 
 
 
 
 
 
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EVENTS 
 
 
Visit 
One 
 
 
Visit 
Two   
 
 
Phone 
Call  
 
 
Visit 
Three 
 
Phone 
call 
Phone 
call 
Phone 
call 
Phone 
call 
Phone 
call 
Visit 
Four 
Nasal mask 
Phone call 
 
 
X 
 
 
 
 
 
 
 
Return the F&P 
Nasal mask  
 
 
 
X 
 
 
 
 
 
 
PAP device data 
downloaded 
 
X 
 
X 
 
 
 
 
 
 
AE/SAE 
assessment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Commence F&P 
Nasal extension if 
participant agrees 
 
 
 
X 
 
 
 
 
 
 
Phone call 
(extension month 1)  
 
 
 
 
X 
 
 
 
 
 
Phone call 
(extension month 2)  
 
 
 
 
 
X 
 
 
 
 
Phone call 
(extension month 3)  
 
 
 
 
 
 
X 
 
 
 
Phone call 
(extension month 4)  
 
 
 
 
 
 
 
X 
 
 
Phone call 
(extension month 5)  
 
 
 
 
 
 
 
 
X 
 
PAP device data 
downloaded 
 
 
 
 
 
 
 
 
 
X 
Return F&P Nasal 
mask. 
 
 
 
 
 
 
 
 
 
X 
Participant 
Questionnaire (see 
Appendix B) 
 
 
 
 
 
 
 
 
 
X 
                                      
 
 
 
 
 
 
 

                               
 
 
 
 
 
 
 
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Visit 2: Participants baseline data downloaded by CSI 
Mask fitting by CSI and issue 
Questionnaire and initial feedback 
Flow test performed 
Visit 3: Exit Interview,  
Questionnaire and patient feedback 
Participant does NOT prefer Nasal mask 
and returns mask  
Trial completion 
 
Visit 3: Exit Interview 
Questionnaire and patient feedback 
Participant prefers F&P Nasal and agrees to 
continue using the mask for another 6 months 
Participants to return F&P Nasal mask at the end 
of the 6 month extension to CSI. 
Questionnaire and Patient Feedback 
Trial Completion 
Minimum 45 existing nasal, sub-nasal and 
pillows mask users on PAP or Bi-Level 
devices 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7 ± 3 days 
14 ± 3days 
Follow up phone call 
3±1 days after Visit 2 
Follow up phone 
call every month 
after Visit 3 
Visit 1: Informed consent (CIA-262)  
Patient demographics and treatment info recorded 
Patient device confirmed for data logging 

                               
 
 
 
 
 
 
 
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With the following section, the days (± N) reflects: the date that will begin for that section (± the range 
within which the visit is acceptable) 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                               
 
 
 
 
 
 
 
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7.16. Withdrawal Criteria 
Participants will be informed that they have the right to withdraw from the study at any time, without 
prejudice to their medical care, and are not obliged to state their reasons. The participants are 
informed that they can revert back to their usual therapy during the clinical investigation if they have 
reason to do so. Additionally the investigator may withdraw a participant at any time for the following 
reasons: 
• 
Protocol Violation 
• 
Safety concerns 
• 
Serious illness 
• 
Adverse event 
The reason for participant discontinuation in the study is to be recorded in the CRF and source 
document. 
 
7.17. Number of Trial Subjects 
A minimum of 45 nasal, sub-nasal and pillows mask users for OSA therapy will be recruited into this 
trial.  
 
7.18. Follow up Plan 
Participants will receive standard care from their health care provider throughout and following the 
study. 

                               
 
 
 
 
 
 
 
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7.19.   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STATISTICAL CONSIDERATIONS 
7.20. Description of the Statistical Design 
Since the trial is regarding the performance and acceptability of the trial device in order to inform 
product development, no statistical design is required. 
 

                               
 
 
 
 
 
 
 
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7.21.   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                               
 
 
 
 
 
 
 
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7.22. Statistical Termination 
No interim analysis will be conducted as statistical outcomes will not change the conduct of the study. 
 
7.23. Statistical Procedure Deviations 
Statistical procedure deviations will be reported to the principal investigator and the sponsor. 
Deviations from the original statistical plan will be explained in the final study report.  
 
7.24.   
 
 
7.25. Statistical Data Management 
Fisher and Paykel Healthcare may consult an external statistician to assist with the analysis of the 
data. 
8. 
Adverse Events and Termination 
An Adverse Event (AE) is any adverse change from the participant’s baseline condition, i.e., any 
unfavourable and unintended sign or symptom or disease that occurs during the course of the study, 
whether or not considered related to the PAP treatment.  All clinically significant AE’s occurring during 
the study will be assessed at each subsequent visit and phone call to assess any change to the 
subject’s health status since the previous interaction.  Any change in health status will be recorded on 
CRF and evaluated by the PI. 
 
Serious AE’s are considered to be AE’s that result in any of the following outcomes, regardless of 
their relationship to the PAP treatment: 
• 
Death 
• 
A life-threatening AE 
• 
In-patient hospitalization or prolongation of existing hospitalization 
• 
A persistent or significant disability/incapacity 
• 
A congenital abnormality/birth defect 
 
8.1. 
  
  
 
 
 
 

                               
 
 
 
 
 
 
 
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17 October 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2. 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.3. 
Reporting Adverse Events 
Any serious AE, due to any cause, that occurs during the study period, must be reported immediately 
(within the next business day) by telephone to the sponsor. In addition to the initial telephone report, a 
Serious Adverse Event form must be completed and sent via facsimile to the sponsor.  All serious 
AE’s must also be recorded on the AE page of the CRF. Additionally, all serious AE’s must be 
reported to the Independent Review Board (IRB) as per the IRB’s requirements.  

                               
 
 
 
 
 
 
 
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8.4. 
Early Termination 
The study may be discontinued at any time on the advice of the responsible investigator on the basis 
of new information regarding safety or efficacy. Additionally, the study may be terminated if progress 
is unsatisfactory. 
 
The following documentation is required if the appropriate party terminates a clinical trial. 
 
8.4.1. 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 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.  
8.4.2. 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. 
8.4.3. Institutional Review Board (IRB) or Independent Ethics Committee (IEC)  
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. 
9. 
Publication Policy 
This study is intended for internal use on the development of the product. However the results of this 
study may be used for marketing purposes or in regulatory documentation to support the clinical 
efficacy of the devices.  
10. 
Approval  
All the required signatories for the approval of this document (Clinical Investigation Plan) are listed on 
the front page of this document with their relevant positions. Signing the below approval indicates that 
the primary investigator (PI) agrees to this version of CIP. 
 
 
  
 
 
 
 

                               
 
 
 
 
 
 
 
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11. 
References 
1. Schein AS, Kerkhoff AC, Coronel CC, Plentz RD, Sbruzzi G. Continuous positive airway 
pressure reduces blood pressure in patients with obstructive sleep apnea; a systematic review 
and meta-analysis with 1000 patients. J Hypertens. 2014;32(9):1762–73. 
2. Marshall NS, Barnes M, Travier N, Campbell AJ, Pierce RJ, McEvoy RD, et al. Continuous 
positive airway pressure reduces daytime sleepiness in mild to moderate obstructive sleep 
apnoea: a meta-analysis. Thorax. 2006;61(5):430–4. 
3. Senaratna CV, Perret JL, Lodge C, Lowe A, Campbell BE, Matheson MC, Hamilton GS, 
Dharmage SC, Prevalence of Obstructive Sleep Apnea in the general population: A systematic 
review, Sleep Medicine Reviews (2016). 
4. Dungan G et al. Randomized Crossover Trial of the Effect of a Novel Method of Pressure 
Control (SensAwake) in Automatic Continuous Positive Airway Pressure Therapy to Treat 
Sleep Disordered Breathing. Journal of Clinical Sleep Medicine 2011;  7(3): 261-267. 
5. Kribbs NB et al. Objective measurement of patterns of nasal CPAP use by patients with 
obstructive sleep apnea. Am Rev Respir Dis 1993; 147(4): 887-95. 
6. Weaver T, Grunstein T (2008) Adherence to continuous positive airway pressure: the challenge 
to effective treatment. Proc Am Thorac Soc 15(5):173–178. 
7. Wolkove N, Baltzan M, Kamel H, Dabrusin R, Palayew M (2008) Long-term compliance with 
continuous positive airway pressure in patients with obstructive sleep apnea. Can Respir J 
15(7):365–369. 
8. Massie CA and Hart RW. Clinical Outcomes related to Interface type in patients with 
Obstructive Sleep Apnea/Hypopnea Syndrome who are using Continuous Positive Airway 
Pressure. Chest 2003; 123:1112-1118. 
9. Elliott MW. The Interface: crucial for successful non-invasive ventilation.  European Respiratory 
Journal 2004; 23:7-8. 
10. Schnohofer B and Sortor-Leger S. Equipment needs for non-invasive mechanical ventilation. 
European Respiratory Journal 2002; 20:1029-1036. 
11. Scharf S et al. Racial Differences in Clinical Presentation of patients with Sleep-Disordered 
Breathing. Sleep and Breathing 2004; 8(4): 173-183. 
12. Meetze K et al. Obstructive Sleep Anea: A Comparison of Black and White Subjects. The 
Laryngoscope 2002; 112(7):1271–1274. 
13. Subramanian S et al. Influence of Gender and Anthropometric Measures on Severity of 
Obstructive Sleep Apnea. Sleep and Breathing 2012; 16(4): 1091-1095. 
14. Davidson T, Patel M. Waist Circumference and Sleep Disordered Breathing. The 
Laryngoscope 2008; 118(2): 339-347. 
15. Schwab RJ et al. An Official American Thoracic Society Statement: Continuous Positive Airway 
Pressure Adherence Tracking Systems: The Optimal Monitoring Strategies and Outcome 
Measures in Adults. Am J Respir Crit Care Med Vol 188, Iss. 5, pp 613–620, Sep 1, 2013. 
16. Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of adult 
obstructive sleep apnea with positive airway pressure: an American Academy of Sleep 
Medicine clinical practice guideline. J Clin Sleep Med. 2019;15(2):335–343. 

                               
 
 
 
 
 
 
 
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17. Guy W,. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. 
Department of Health, Education, and Welfare. 
18. Baltzan MA, Dabrusin R, Garcia-Asensi A, Sully J-L, Parenteau M, Tansimat G, et al. Leak 
Profile Inspection During Nasal Continuous Positive Airway Pressure. Respir Care. 2011 
May;56(5):591 LP-595.  
19. Teschler H, Stampa J, Ragette R, Konietzko N, Berthon-Jones M. Effect of mouth leak on 
effectiveness of nasal bilevel ventilatory assistance and sleep architecture. Eur Respir J. Eur 
Respiratory Soc; 1999;14(6):1251–7.  
20. Morgenthaler TI, Aurora RN, Brown T, Zak R, Alessi C, Boehlecke B, et al. Practice 
parameters for the use of autotitrating continuous positive airway pressure devices for titrating 
pressures and treating adult patients with obstructive sleep apnea syndrome: an update for 
2007. An American Academy of Sleep Medicine report. Sleep [Internet]. Associated 
Professional Sleep Societies, LLC; 2008 Jan 1;31(1):141–7. 
21. Applying  Human Factors and Usability Engineering to Medical Devices: Guidance for Industry 
and Food and Drug Administration (FDA) staff. Issued on 03 February 2016.  
 
 
 

                               
 
 
 
 
 
 
 
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12. 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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13. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14. 
 
 
 
 

                               
 
 
 
 
 
 
 
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15. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                               
 
 
 
 
 
 
 
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