Randomized Controlled Trial to Compare Effectiveness of DreamPort-Eclipse to a Traditional Nasal Mask
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: Bleep, LLC

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  1 
 CLINICAL STUDY PROTOCOL 
 Title: 
 Randomized Controlled Trial of Bleep DreamPort-Eclipse 
 Protocol Number: 
 BSL-SNAP-003 
 Study Type: 
 Date: 
 Randomized Controlled Trial 
 14 September 2021 
 Version: 
 1.3 
 Study Devices: 
 DreamPort-Eclipse:  Compact,  ultra-low  contact,  custom  fit 
 CPAP human interface solution for obstructive sleep apnea 
 Sponsor: 
 Bleep, LLC 
 758 The Preserve Trl 
 Chapel Hill, NC 27517-7688 
 04-August-2021 
 Sponsor – Stuart Heatherington - CEO 
 Date 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its affiliates. 
 Neither this document nor the information therein may be reproduced, used, or disclosed to or for the benefit of any 
 third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  2 
 Sponsor Contacts: 
 Bleep, LLC 
 758 The Preserve Trl 
 Chapel Hill, NC 27517-7688 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its affiliates. 
 Neither this document nor the information therein may be reproduced, used, or disclosed to or for the benefit of any 
 third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  3 
 Revision History: 
 Protocol Version #  Protocol Date 
 Description of Changes 
 1.0 
 22 April 2021 
 Initial Protocol Version 
 1.1 
 07 July 2021 
 Edited adverse event definition 
 1.2 
 04 August 2021 
 Revision  to  statistical  analysis  and  power 
 calculation 
 1.3 
 14 September 2021  Fixed  errors  referring  to  3  devices  to  2 
 devices 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its affiliates. 
 Neither this document nor the information therein may be reproduced, used, or disclosed to or for the benefit of any 
 third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  4 
 PROTOCOL SUMMARY 
 Title: 
 Randomized Controlled Trial of Bleep DreamPort-Eclipse 
 Design: 
 Randomized controlled trial 
 Objectives: 
 This  randomized  controlled  trial  is  being  conducted  to  collect  data  to  determine 
 if  participants  are  more  compliant  using  the  novel  DreamPort-Eclipse  design 
 compared  to  a  standard  CPAP  mask,  as  well  as  assess  general  usability  and 
 technical performance (AHI, leak, pressure settings) in the home. 
 Procedures: 
 Participants  will  receive  a  brief  training  session  on  the  prototype  device  in  the 
 clinic  and  will  be  provided  with  the  training  guides  as  well  as  have  access  to  the 
 online  video  tutorials.  We  will  complete  a  randomized,  prospective,  non-blinded 
 trial  to  determine  the  influence  of  mask  choice  on  obstructive  sleep  apnea  (OSA) 
 treatment  compliance,  as  this  is  the  major  source  of  abandonment  of  CPAP 
 therapy.  Eligible  participants  will  be  randomly  assigned  to  one  of  two  study 
 groups:  50  participants  assigned  to  the  DreamPort-Eclipse  and  50  participants  to 
 a  traditional  nasal  mask.  All  participants  will  be  de-identified  by  subject  IDs  in 
 the data collection. 
 Devices: 
 This  comparative  study  design  and  data  collection  will  involve  two  different 
 CPAP  interfaces:  a  traditional  CPAP  mask  and  the  next  generation 
 DreamPort-Eclipse. 
 Study Sites: 
 Bleep, LLC, Advanced Respiratory & Sleep Medicine, and Aeroflow Sleep 
 Enrollment: 
 We  plan  to  recruit  100  newly  diagnosed  OSA  participants  over  the  age  of  18.  We 
 will  oversample  for  participants  who  are  Hispanic  or  African  American.  We  will 
 aim  to  recruit  participants  with  the  following  racial  and  ethnic  breakdown:  30% 
 White;  40%  Black;  10%  Asian;  and  20%  Hispanic.  We  will  also  recruit  an 
 estimated  60%  men  and  40%  women  to  reflect  the  OSA  population,  which 
 affects more men than woman. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its affiliates. 
 Neither this document nor the information therein may be reproduced, used, or disclosed to or for the benefit of any 
 third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  5 
 Eligibility 
 Criteria: 
 The  subject’s  eligibility  for  study  enrollment  will  be  reviewed  and  documented 
 on the appropriate case report form (CRF). 
 Inclusion Criteria 
 The  subject  is  a  male  or  female  ≥18  years  old  who  are  impacted  by  obstructive 
 sleep apnea and currently are familiar with a CPAP device. 
 Exclusion Criteria 
 Subjects  will  be  excluded  if  they  have  any  medical  or  behavioral  conditions  that 
 would  compromise  subject  safety.  Subjects  under  the  age  of  18  will  be  excluded 
 from  this  study,  as  the  target  for  this  current  version  of  the  platform  is  the  adult 
 population. 
 Primary 
 Outcomes: 
 The  following  primary  outcomes  will  be  measured  over  the  two-month 
 study period: 
 Apnea-Hypopnea Index (AHI): 
 The  Apnea–Hypopnea  Index  or  Apnoea–Hypopnoea  Index  (AHI)  is  an  index 
 used  to  indicate  the  severity  of  sleep  apnea.  It  is  represented  by  the  number  of 
 apnea  and  hypopnea  events  per  hour  of  sleep.  The  apneas  (pauses  in  breathing) 
 must  last  for  at  least  10  seconds  and  be  associated  with  a  decrease  in  blood 
 oxygenation. For OSA treatment, we are looking to see AHI decrease to <5. 
 Leak: 
 Leak  can  be  caused  by  several  issues—  having  the  wrong  mask  size  or  type,  the 
 mask  not  being  assembled  or  fitted  correctly,  or  parts  being  worn  out  and 
 needing  replacement.  The  acceptable  leak  rate  is  up  to  24  litres  per  minute. 
 Anything below this means the patient is still getting the full benefits of therapy. 
 CPAP Device Pressure: 
 CPAP  device  pressure  is  expected  to  decrease  with  decrease  leak  with  the  novel 
 mask. 
 Secondary 
 Outcomes: 
 The  following  secondary  outcomes  will  be  measured  over  the  two-month 
 study period: 
 Participant satisfaction with the mask choice: 
 Satisfaction will be based on a participant questionnaire in which they indicate 
 their overall satisfaction with the mask they are assigned. 
 Mask Acceptance: 
 Mask acceptance will be defined by continued use versus discontinued use. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its affiliates. 
 Neither this document nor the information therein may be reproduced, used, or disclosed to or for the benefit of any 
 third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  6 
 Sample Size 
 Estimation: 
 In  order  to  achieve  a  power  of  at  least  80%  to  detect  AHI  and  leak,  the  minimum 
 necessary  sample  size  is  n=88,  as  calculated  using  the  software  G*Power.  With  a 
 plan  to  recruit  a  total  of  100  newly  diagnosed  OSA  patients  as  described  above, 
 we expect to achieve a power of approximately 98% for this procedure. 
 Data 
 Collection: 
 At  baseline,  the  data  to  be  collected  will  include  CPAP  interface  characteristics 
 and  CPAP  settings.  At  one  and  two-month  follow  up  visits,  study  coordinators 
 will  record  the  number,  duration  and  cause  of  mask-related  contacts,  number  of 
 visits  dedicated  to  the  mask,  primary  cause  of  a  change  in  first-line  mark,  or 
 discontinuation  of  CPAP,  compliance,  change  in  CPAP  pressure  and  patient 
 satisfaction  via  a  questionnaire.  All  data  will  be  acquired  from  the  research 
 procedures  performed  during  usability  assessments  on  human  individuals.  Data 
 that  will  be  collected  from  participants  includes  demographic  data  and  survey 
 feedback.  All  participants  will  be  represented  by  subject  IDs  in  the  data  in  order 
 to maintain patient confidentiality. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its affiliates. 
 Neither this document nor the information therein may be reproduced, used, or disclosed to or for the benefit of any 
 third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  7 
 Investigator’s Responsibility 
 Prior  to  participation  in  this  study,  the  Investigator  or  Institution  must  obtain  written  approval 
 from  his/her  Institutional  Review  Board  (IRB).  This  approval  must  be  in  the  Investigator’s  name 
 and  a  copy  sent  to  Bleep  (“Sponsor”)  along  with  the  IRB  approved  Informed  Consent  Form 
 (ICF)  (if  applicable)  prior  to  the  start  of  the  study.  The  Investigator  or  designee  must  receive 
 Bard  Peripheral  Vascular-Sponsored  training  prior  to  site  activation. 
 The  Investigator  is 
 responsible  for  training  all  clinical  staff  to  ensure  adequate  training  is  obtained  prior  to 
 performing any data collection or study-related procedures. 
 The Investigator must also: 
 ●  Conduct  the  study  in  accordance  with  the  study  protocol,  any  modifications  as  requested 
 by  the  IRB,  the  Declaration  of  Helsinki,  applicable  national  privacy  laws  (e.g.,  Health 
 Insurance  Portability  and  Accountability  Act  (HIPAA)  requirements  in  the  U.S.), 
 applicable  Food  and  Drug  Administration  (FDA)  regulations  (e.g.,  21  Code  of  Federal 
 Regulations (CFR) Parts 50, 54, 56, and ISO 14155:2011. 
 ●  Ensure that the study does not commence until IRB approval has been obtained. 
 ●  If  applicable,  ensure  that  written  informed  consent  is  obtained  from  each  subject  prior  to 
 the conduct of any study procedure, using the current IRB-approved ICF. 
 ●  Provide  all  required  data  and  reports  and  agree  to  source  document  verification  of  study 
 data with subject’s medical records. 
 ●  Allow  Sponsor  personnel  or  their  designee(s),  as  well  as  regulatory  agency 
 representatives  and  other  applicable  authorities,  to  inspect  and  copy  any  documents 
 pertaining to the study. 
 ●  Provide  appropriate  resources  to  ensure  compliance  with  all  study-related  procedures  and 
 prompt submission of all electronic case report forms (eCRFs). 
 The  Investigator  retains  overall  responsibility  for  IRB  approval  and  proper  conduct  of  the  study, 
 including  obtaining  and  documenting  the  Informed  Consent  process  (if  applicable),  compliance 
 with  the  study  protocol,  the  collection  of  all  required  data,  and  ensuring  that  all  study  personnel 
 have been properly trained on the protocol and have received other necessary training. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its affiliates. 
 Neither this document nor the information therein may be reproduced, used, or disclosed to or for the benefit of any 
 third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  8 
 Investigator Protocol Signature Page 
 Site Name: _________________________________________ 
 I  have  read  and  understand  the  contents  of  this  protocol.  I  agree  to  follow  and  abide  by  the 
 requirements  set  forth  in  this  document.  I  agree  to  conduct  the  study  in  accordance  with  the 
 study  protocol,  any  modifications  as  requested  by  the  IRB,  the  Declaration  of  Helsinki, 
 applicable  national  privacy  laws  (e.g.,  HIPAA  requirements  in  the  US),  GCP  as  well  as 
 applicable  FDA  regulations  (21  CFR  Parts  50,  54,  56)  and  ISO  14155:2011.  I  agree  to 
 participate  in  Sponsored  training  prior  to  performing  any  data  collection  or  study-related 
 procedures. 
 _______________________________________________ 
 Printed Name – Investigator 
 _______________________________________________ 
 Signature – Investigator 
 _______________________________________________ 
 Date 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its affiliates. 
 Neither this document nor the information therein may be reproduced, used, or disclosed to or for the benefit of any 
 third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  9 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  10 
 Sub-Investigator Protocol Signature Page 
 Site Name: _________________________________________ 
 I  have  read  and  understand  the  contents  of  this  protocol.  I  agree  to  follow  and  abide  by  the 
 requirements  set  forth  in  this  document.  I  agree  to  conduct  the  study  in  accordance  with  the 
 study  protocol,  any  modifications  as  requested  by  the  IRB,  the  Declaration  of  Helsinki, 
 applicable  national  privacy  laws  (e.g.,  HIPAA  requirements  in  the  US),  GCP  as  well  as 
 applicable  FDA  regulations  (21  CFR  Parts  50,  54,  56)  and  ISO  14155:2011.  I  agree  to 
 participate  in  Sponsored  training  prior  to  performing  any  data  collection  or  study-related 
 procedures. 
 _______________________________________________ 
 Printed Name – Investigator 
 _______________________________________________ 
 Signature – Investigator 
 _______________________________________________ 
 Date 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  11 
 C ONTENTS 
 PROTOCOL SUMMARY 
 4 
 1. 
 INTRODUCTION 
 12 
 1.1 
 Introduction 
 12 
 1.2 
 Device Description 
 12 
 2. 
 STUDY OBJECTIVE 
 12 
 3. 
 STUDY DESIGN 
 12 
 4. 
 STUDY OUTCOMES 
 12 
 4.1 
 Primary Outcomes: 
 12 
 4.2 
 Secondary Endpoints: 
 13 
 5. 
 STUDY POPULATION 
 13 
 5.1 
 Number of Subjects 
 13 
 5.2 
 Eligibility Criteria 
 13 
 5.2.1 
 Inclusion Criteria 
 13 
 5.2.2 
 Exclusion Criteria 
 13 
 6. 
 INDEX PROCEDURE, EVALUATIONS, AND SCHEDULE 
 13 
 6.1 
 Enrollment 
 13 
 6.1.1 
 Informed Consent and Enrollment 
 14 
 6.1.2 
 Demographics and Medical History 
 14 
 6.1.3 
 Physical Examinations 
 14 
 6.1.4 
 Assignment of Subject Number 
 14 
 6.2 
 Index Procedure Data 
 14 
 6.2.1 
 Index Procedure Details 
 14 
 6.3 
 Clinical Follow-Up 
 15 
 7. 
 ASSESSMENT OF SAFETY 
 15 
 7.1 
 Deﬁnition of Events 
 15 
 7.1.1 
 Adverse Events (AE) 
 15 
 7.1.2 
 Serious Adverse Event (SAE) 
 15 
 7.2 
 Severity of Adverse Events 
 16 
 7.3 
 Relationship of Adverse Event to Device/Procedure 
 16 
 8. 
 STATISTICAL CONSIDERATIONS 
 16 
 8.1 
 Sample Size Considerations 
 16 
 8.2 
 Data Analysis 
 17 
 9. 
 MECHANICAL FAILURES, MALFUNCTIONS, AND DEFECTS 18 
 10. 
 DATA COLLECTION, QUALITY, AND RECORD RETENTION  18 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  12 
 10.1 
 Data Collection and Record Maintenance 
 18 
 10.2 
 Source Documents 
 18 
 10.3 
 Quality Assurance and Quality Control (QC) 
 18 
 10.4 
 Record Retention 
 18 
 11. 
 ADMINISTRATIVE REQUIREMENTS 
 19 
 11.1 
 Investigator Selection 
 19 
 11.2 
 Communications with the Sponsor 
 19 
 11.3 
 Investigator Training 
 19 
 11.4 
 Required Documentation 
 19 
 11.5 
 Protocol Adherence and Deviations 
 20 
 11.6 
 Publication and Data Sharing Policy 
 20 
 12. 
 CLINICAL SITE MONITORING AND AUDIT 
 20 
 12.1 
 Site Initiation Visit 
 21 
 12.2 
 Close-Out Visit 
 21 
 13. 
 REGULATORY AND ETHICAL CONSIDERATIONS 
 21 
 13.1 
 Ethical Standard 
 21 
 13.2 
 Institutional Review Board Approval 
 21 
 13.3 
 Investigator Reports 
 22 
 13.4 
 Participant and Data Conﬁdentiality 
 22 
 13.5 
 Conﬂict of Interest Policy 
 22 
 14. 
 PREMATURE TERMINATION OR SUSPENSION OF STUDY 
 22 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  13 
 1.  INTRODUCTION 
 1.1 
 Introduction 
 The  Randomized  Controlled  Trial  of  Bleep  DreamPort-Eclipse  Study  is  a  two-arm, 
 randomized,  prospective,  non-blinded  study  to  determine  the  influence  of  mask  choice  on 
 obstructive  sleep  apnea  (OSA)  treatment  compliance,  as  this  is  the  major  source  of 
 abandonment  of  CPAP  therapy.  We  will  assess  the  effectiveness  of  the  novel  CPAP  human 
 interface design to improve leak, AHI, and pressure compared to a traditional nasal mask. 
 1.2 
 Device Description 
 Human  subjects  will  interact  with  one  of  two  different  CPAP  interfaces  based  on  random 
 assignment: a traditional CPAP mask or the next generation DreamPort-Eclipse. 
 2.  STUDY OBJECTIVE 
 This minimal risk study is being conducted to collect data to compare the usability of two 
 different CPAP modalities. 
 3.  STUDY DESIGN 
 This  randomized  controlled  trial  (RCT)  is  designed  to  assess  the  effectiveness  of  the 
 DreamPort-Eclipse  CPAP  mask  in  comparison  to  a  traditional  nasal  mask.  Data  is  being 
 collected  to  determine  if  users  are  more  compliant  to  CPAP  therapy  using  the  DreamPort 
 compared  to  traditional  mask  designs,  as  well  as  general  usability  and  technical  performance 
 (AHI,  leak)  during  overnight  use  over  two  months.  We  anticipate  recruiting  100  adult 
 subjects  who  are  impacted  by  obstructive  sleep  apnea  and  currently  are  familiar  with  a  CPAP 
 device. 
 4.  STUDY OUTCOMES 
 4.1 
 Primary Outcomes: 
 The following primary outcomes will be measured over the two-month study period: 
 Apnea-Hypopnea Index (AHI): 
 The  Apnea–Hypopnea  Index  or  Apnoea–Hypopnoea  Index  (AHI)  is  an  index  used  to  indicate 
 the  severity  of  sleep  apnea.  It  is  represented  by  the  number  of  apnea  and  hypopnea  events  per 
 hour  of  sleep.  The  apneas  (pauses  in  breathing)  must  last  for  at  least  10  seconds  and  be 
 associated  with  a  decrease  in  blood  oxygenation.  For  OSA  treatment,  we  are  looking  to  see 
 AHI decrease to <5. 
 Leak: 
 Leak  can  be  caused  by  a  number  of  issues—  having  the  wrong  mask  size  or  type,  the  mask 
 not  being  assembled  or  fitted  correctly,  or  parts  being  worn  out  and  needing  replacement.  The 
 acceptable  leak  rate  is  up  to  24  litres  per  minute.  Anything  below  this  means  the  patient  is 
 still getting the full benefits of therapy. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  14 
 CPAP Device Pressure: 
 CPAP  device  pressure  is  expected  to  decrease  with  decrease  leak  through  the  use  of  the  novel 
 mask. 
 4.2 
 Secondary Endpoints: 
 The following secondary outcomes will be measured over the two-month study period: 
 Participant satisfaction with the mask choice: 
 Satisfaction will be based on a participant questionnaire in which they indicate their overall 
 satisfaction with the mask they are assigned. 
 Mask Acceptance: 
 Mask acceptance will be defined by continued use versus discontinued use. 
 5.  STUDY POPULATION 
 5.1 
 Number of Subjects 
 Data collection will continue until 100 eligible subjects have been enrolled at three sites. 
 5.2 
 Eligibility Criteria 
 Subjects will be enrolled into the study based upon the inclusion/exclusion criteria listed 
 below. 
 5.2.1  Inclusion Criteria 
 To be eligible for inclusion in this study, a subject must meet all of the following criteria: 
 1.  The  subject  is  a  male  or  female  ≥18  years  old  who  are  impacted  by  obstructive 
 sleep apnea and currently are familiar with a CPAP device. 
 5.2.2  Exclusion Criteria 
 Subjects  will  be  excluded  if  they  have  any  medical  or  behavioral  conditions  that  would 
 compromise  subject  safety.  Subjects  under  the  age  of  18  will  be  excluded  from  this  study,  as 
 the target for this current version of the platform is the adult population. 
 6.  INDEX PROCEDURE, EVALUATIONS, AND SCHEDULE 
 6.1 
 Enrollment 
 6.1.1  Informed Consent and Enrollment 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  15 
 Prior  to  data  collection  and  study  enrollment,  the  protocol  will  be  explained  in  detail  to  the 
 participants  and  informed  consent  will  be  obtained.  All  participants  will  be  provided  written 
 informed  consent  prior  to  participation.  The  information  about  the  research  study  will  be 
 provided to the participant in written form as well as read aloud to the participant. 
 Prior  to  the  collection  of  any  study-specific  data  or  conduct  of  any  study-specific  procedures, 
 the  subject  must  voluntarily  provide  written  informed  consent  (if  needed)  and  comply  with 
 applicable  national  privacy  laws.  All  study  procedures  will  be  documented  in  the  medical 
 record and/or source document and on study case report forms (CRFs). 
 6.1.2  Demographics and Medical History 
 The subject’s demographic information will be collected and documented on the appropriate 
 CRFs (i.e., Age (years), sex and initials). 
 6.1.3  Physical Examinations 
 No physical examination will take place. 
 6.1.4  Assignment of Subject Number 
 A unique participant identification number (PID) will be assigned to enrolled subjects. 
 Participant or Subject numbers will be assigned in sequential order. The Participant or 
 Subject number will consist of six digits. The first three digits will designate the study site. 
 The last three digits will designate the subject by number in sequential order (e.g., 210-001, 
 210-002…). 
 6.2 
 Index Procedure Data 
 6.2.1  Index Procedure Details 
 Index  procedure  details  will  be  collected  on  all  enrolled  subjects.  The  Index  procedure  is 
 defined  as  the  SNAP  CPAP  protocol  in  accordance  with  the  instructions  for  use  (IFU).  Such 
 details related to this protocol may include, but are not limited to the following: 
 ●  Date of Usability Test 
 ●  Product Name, Catalogue Number, Lot Number 
 ●  Configuration Details 
 ●  Indication 
 ●  Accessory details 
 ●  All  adverse  events,  device  malfunction,  and  complications  related  to  device  or 
 procedure 
 6.3 
 Clinical Follow-Up 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  16 
 After two months, participants will visit the study site, which is the clinic (either Advanced 
 Respiratory & Sleep Medicine or Aeroflow Sleep) where they receive their standard OSA 
 care. 
 7.  ASSESSMENT OF SAFETY 
 The  Investigator  is  responsible  for  the  detection  and  documentation  of  events  meeting  the 
 criteria  and  definition  of  an  Adverse  Event  (AE),  Serious  Adverse  Event  (SAE)  and 
 unanticipated  Adverse  Device  Effects  (UADE)  as  provided  in  this  protocol.  The  occurrence 
 of  AEs  should  be  documented  in  the  source  documents  and  reported  using  the  appropriate 
 CRF.  Events  that  occur  prior  to  the  index-procedure  should  be  captured  within  the  subject’s 
 medical history. 
 7.1 
 Definition of Events 
 7.1.1  Adverse Events (AE) 
 An  AE  is  defined  as  any  untoward  medical  occurrence,  unintended  disease  or  injury,  or 
 untoward  clinical  signs  (including  abnormal  laboratory  findings)  in  subjects,  users  or  other 
 persons, whether or not related to the study device [ISO14155:2011 (E)]. 
 Abnormal  laboratory  results  are  not  to  be  considered  AEs  unless  the  results  are  accompanied 
 by  clinical  signs  or  symptoms.  Preexisting  conditions  should  be  considered  as  part  of  the 
 subject’s  medical  history.  Any  medical  condition  that  is  present  before  the  intervention  will 
 be  considered  medical  history  and  should  not  be  reported  as  an  AE.  However,  if  the  subject’s 
 condition  deteriorates,  or  there  is  a  substantial  increase  in  severity  or  frequency  of  the 
 condition  (worsening  of  the  underlying  disease),  which  has  not  been  attributed  to  natural 
 history during the subject’s clinical follow-up, it will be recorded as an AE. 
 7.1.2  Serious Adverse Event (SAE) 
 Each  AE  will  be  assessed  to  determine  whether  it  is  serious  or  non-serious.  (Note:  the  term 
 serious  is  not  synonymous  with  severity,  which  may  be  used  to  describe  the  intensity  of  an 
 event experienced by the subject).  A SAE is an AE that: 
 1.  Led to death: or 
 2.  Led to serious deterioration in the health of the subject, that either resulted in: 
 a.  A life-threatening illness or injury; 
 b.  A permanent impairment of a body structure or body function: 
 c.  In-patient or prolonged existing hospitalization (>24 hours); or 
 d.  Medical  or  surgical  intervention  to  prevent  life-threatening  illness  or  injury  or 
 permanent impairment to a body structure or body function 
 e.  Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
 NOTE:  Planned  hospitalizations  for  a  preexisting  condition  (prior  to  device  use),  or  a 
 procedure without serious deterioration in health, are not considered an SAE. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  17 
 7.2 
 Severity of Adverse Events 
 Each  AE  should  be  assessed  for  its  severity,  or  the  intensity  of  an  event,  experienced  by  the 
 subject. 
 1.  Mild :  Awareness  of  a  sign  or  symptom  that  does  not  interfere  with  the  subject’s 
 activity or is transient and is resolved without treatment or sequelae. 
 2.  Moderate : 
 May  interfere  with  the  subject’s  activity  and  require  additional 
 intervention and/or treatment and may have additional sequelae. 
 3.  Severe :  Significant  discomfort  to  the  subject  and/or  interferes  with  their  activity. 
 Additional  intervention  and/or  treatment  are  necessary.  Additional  sequelae  occur. 
 Severe is used to describe the intensity of an event experienced by the subject. 
 7.3 
 Relationship of Adverse Event to Device/Procedure 
 Each  AE/SAE  will  be  assessed  for  its  relationship  to  the  product(s)  being  studied  or  surgical 
 procedures as follows: 
 1.  Device-Related :  This  category  should  be  restricted  to  AEs  directly  attributable  to 
 the devices being studied in the study. 
 The following categories will be used to assign the certainty of the relationship: 
 1.  Definitely  Related :  An  AE  is  definitely  related  if  the  AE  is  known  to  occur  with 
 the  product(s),  there  is  a  reasonable  possibility  that  the  product(s)  caused  the  AE, 
 or  there  is  a  temporal  relationship  between  use  of  the  product(s)  and  the  event. 
 Reasonable  possibility  means  that  there  is  evidence  to  suggest  a  causal 
 relationship between the product(s) and the AE. 
 2.  Possibly  Related :  An  AE  is  possibly  related  if  it  is  capable  of  being  related  but 
 relatively unlikely. 
 2.  Not  Related :  An  AE  is  not  related  if  it  is  determined  that  there  is  no  reasonable 
 possibility  that  the  product(s)  caused  the  event,  there  is  no  temporal  relationship 
 between  the  product(s)  and  event  onset,  or  an  alternate  etiology  has  been 
 established. 
 8.  STATISTICAL CONSIDERATIONS 
 This section describes the planned statistical analyses for this study. 
 8.1 
 Sample Size Considerations 
 This  study  aims  to  achieve  three  outcomes  to  95%  significance  (alpha  =  0.05)  and  80% 
 power or higher: 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  18 
 1.  Is  the  Dreamport  CPAP  effective  with  an  AHI  <  3  (a  standard  threshold 
 considered “good” by the community of CPAP users)? 
 2.  Does the Dreamport CPAP mask leak less than the traditional CPAP mask? 
 3.  Does  the  Dreamport  CPAP  mask  promote  better  adherence  than  the  traditional 
 CPAP mask? 
 In  order  to  achieve  a  power  of  at  least  80%  for  each  of  these  tests,  a  minimum  sample  size  of 
 n=88  is  necessary.  With  a  plan  to  recruit  a  total  of  100  newly  diagnosed  OSA  patients  as 
 described  above,  we  expect  to  achieve  a  power  of  100%  (is  AHI  <3?),  98%  (is  Leak  better 
 than  in  traditional  masks?),  and  85%  (is  adherence  better  than  in  traditional  masks?), 
 depending on the actual effect size of the sample collected. 
 Sample  size  requirements  were  estimated  using  G*Power.  For  AHI  and  Leak  metrics,  data 
 collected  from  a  previous  study  was  used  to  estimate  the  expected  mean,  standard  deviation, 
 and  effect  sizes  for  this  study.  The  minimum  sample  size  required  for  testing  AHI  efficacy  is 
 n=3.  The  minimum  sample  size  required  for  comparing  Leak  L/min  to  the  traditional  mask  is 
 n=42. 
 There  are  no  previous  studies  to  estimate  expected/required  effect  size  for  differences 
 between  masks  in  patient  adherence.  As  such,  an  effect  size  of  0.30  (“medium”)  was  used  to 
 determine  sample  size  requirements.  Based  on  these  model  attributes,  in  order  to  achieve  a 
 power of at least 80%, the minimum necessary sample size is n=88. 
 8.2 
 Data Analysis 
 In  order  to  test  whether  the  mask  meets  acceptable  AHI  standards,  a  one-sided  t-test  will  be 
 conducted  to  compare  the  collected  sample  average  of  patients  assigned  to  the 
 DreamPort-Eclipse  mask  to  the  community-accepted  threshold  of  3.  Based  on  our  previous 
 FDA  study,  it  is  expected  that  the  mean  for  this  study  will  be  between  0-1.23  (95% 
 confidence  interval,  n=25,  mean=0.5968,  SD=0.3712).  As  such,  the  required  sample  size  to 
 achieve a power of 80% is n=3. 
 Additionally,  this  study  aims  to  compare  the  leak  rate  of  the  DreamPort-Eclipse  mask  to  that 
 of  a  traditional  nasal  mask.  To  conduct  the  comparison,  a  one-sided  t-test  will  be  used.  The 
 estimated  effect  size  used  to  calculate  sample  size  is  0.7922  based  on  how  leakage  with  the 
 DreamPort  mask  compared  to  that  of  another  brand’s  mask.  Based  on  this  effect  size,  the 
 required  sample  size  to  achieve  80%  power  is  42.  The  effect  size  in  this  study  may  be 
 different,  but  with  a  plan  to  recruit  100  patients  to  the  study,  the  sample  should  be  more  than 
 sufficient. 
 For  secondary  outcomes  of  patient  satisfaction  and  mask  acceptance,  at  each  of  the  follow-on 
 visits,  patients  will  be  asked  to  take  a  questionnaire  to  indicate  their  overall  satisfaction  with 
 the  device  they  have  been  assigned.  In  order  to  determine  if  there  are  statistically  significant 
 differences  between  groups/devices,  student’s  t-test  with  independent  samples  will  be 
 conducted, with a patient satisfaction score as the dependent variable across 2 groups. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  19 
 We  also  expect  the  first-line  mask  adherence  rate  to  be  higher  at  the  2-month  interval  using 
 the  DreamPort-Eclipse  compared  to  a  traditional  mask.  This  will  be  tested  using  a  Chi-Sq  test 
 of  independence,  by  comparing  the  proportions  of  patients  who  continue  use  of  the  mask  by 
 the  2-month  follow-up  visit  between  groups.  The  Chi-Square  procedure  will  have  2  “rows” 
 (one  for  each  group/device),  and  2  “columns”  (for  the  response  groups:  Continued  to  Use  vs 
 Discontinued  Use).  As  such,  the  procedure  will  have  (2-1)x(2-1)  =  1  degree  of  freedom,  and 
 will  require  a  sample  size  of  n=88  in  order  to  achieve  a  power  of  80%.  With  a  plan  to  recruit 
 a  total  of  100  newly  diagnosed  OSA  patients  as  described  above,  we  expect  to  achieve  a 
 power  of  approximately  85%  for  this  procedure.  We  will  use  a  logistic  procedure  with 
 backward  stepwise  regression  analysis  to  determine  predictive  factors  associated  with  nasal 
 mask  acceptance.  Survival  analysis  of  nasal  mask  failure  will  be  performed  using 
 Kaplan-Meier  survival  estimates  and  compared  between  groups  using  a  Log-Rank  test. 
 Quantitative  variables  will  be  described  in  terms  of  mean,  standard  deviation,  median,  and 
 range,  while  qualitative  variables  will  be  described  in  terms  of  absolute  frequency  and 
 percentage. 
 Other  study  information  collected  such  as  demographics,  medical  history,  AEs,  comparisons 
 of pressure & AHI between masks, etc. will be summarized as well. 
 9.  MECHANICAL FAILURES, MALFUNCTIONS, AND DEFECTS 
 During  the  RCT,  our  Bleep,  LLC  support  team  will  problem  solve  any  issues  that  arise  with 
 the study and provide support to ensure success of the study. 
 10.  DATA COLLECTION, QUALITY, AND RECORD RETENTION 
 10.1  Data Collection and Record Maintenance 
 The  Investigator  or  designee  is  responsible  for  completely  and  accurately  recording  study 
 data  in  the  appropriate  sections  of  the  CRFs  provided.  The  CRFs  must  be  signed  by  the 
 Investigator or by his/her documented designee. 
 When  applicable,  the  monitor  will  ensure  the  accuracy  of  data  recording  at  each  site  by 
 comparing  recorded  data  to  supporting  source  documents  during  periodic  site  visits. 
 Adherence  to  proper  recording  of  information  as  well  as  ensuring  that  corrections  are  being 
 made will also be addressed during these periodic visits. 
 10.2  Source Documents 
 Each  participating  site  will  maintain  appropriate  medical  and  research  records  for  this  study, 
 in  compliance  with  regulatory  and  institutional  requirements  for  the  protection  of 
 confidentiality of participants. 
 10.3  Quality Assurance and Quality Control (QC) 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  20 
 The  Investigator  is  responsible  for  ensuring  the  accuracy  and  completeness  of  all  study 
 documentation.  All  clinical  study  data  will  be  recorded  in  the  eCRFs  provided  to  the 
 investigational site. 
 The  investigational  site  will  provide  direct  access  to  all  study  related  sites,  source 
 data/documents,  and  reports  if  monitoring  and  auditing  by  the  Sponsor,  and  inspection  by 
 local  and  regulatory  authorities  is  requested.  Regular  monitoring  and  an  independent 
 audit,  if  conducted,  will  be  performed  according  to  International  Council  for 
 Harmonization - Good Clinical Practice (ICH-GCP). 
 10.4  Record Retention 
 The  Investigator  shall  retain  all  study  records  for  a  period  of  2  years  after  the  date  on  which 
 the  study  is  terminated  or  completed.  The  Investigator  may  withdraw  from  the  responsibility 
 to  maintain  records  for  the  period  required  by  transferring  custody  of  the  records  to  any  other 
 person  who  will  accept  responsibility  for  retaining  them.  Notice  of  a  transfer  shall  be  given 
 to Bleep not later than 10 business days after the transfer occurs. 
 11.  ADMINISTRATIVE REQUIREMENTS 
 11.1  Investigator Selection 
 The  Investigator  must  be  of  good  standing  as  an  Investigator  and  knowledgeable  in  relevant 
 areas  of  clinical  research  to  ensure  adherence  to  the  requirements  of  the  protocol,  including 
 the  protection  of  human  subjects.  Other  site  personnel  must  have  appropriate  research 
 experience  and  infrastructure  to  ensure  adherence  to  the  protocol.  The  curriculum  vitae  (CV) 
 of  the  Investigator  will  be  maintained  in  the  Sponsor  files  as  documentation  of  previous 
 medical  training,  and  federal  databases  will  be  searched  to  ensure  that  the  Investigator  and/or 
 the  site  are  not  prohibited  from  engaging  in  federally  Sponsored  clinical  research.  The 
 Principal  Investigator  will  sign  the  signature  page  of  this  protocol,  agreeing  to  comply  with 
 all applicable government regulations and the requirements of this study. 
 11.2  Communications with the Sponsor 
 Although  the  Investigator  and  his/her  staff  may  have  contact  with  other  key  individuals  at  the 
 Sponsor  throughout  the  course  of  the  study,  all  communications  regarding  conduct  of  the 
 study must be channeled through the Sponsor’s clinical affairs personnel or designees. 
 11.3  Investigator Training 
 Prior  to  the  start  of  the  study  Investigators  will  undergo  a  mandatory  study  training  that  will 
 be  designed  to  cover  all  aspects  of  data  collection  and  the  requirements  of  this  Clinical 
 Protocol. 
 The  training  is  designed  to  enhance  protocol  adherence. 
 All  training 
 documentation  will  be  maintained  by  the  Sponsor  within  an  electronic  Trial  Master  File  and 
 is expected to be maintained locally at participating sites in regulatory files or equivalent. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  21 
 11.4  Required Documentation 
 An  Investigator  may  not  commence  study  activities  until  authorized  to  do  so  by  the  Sponsor 
 in  writing.  At  a  minimum,  the  following  documentation  must  be  received  by  the  Sponsor 
 prior to study commencement: 
 1. 
 Signed Nondisclosure Agreement by the Investigator; 
 2. 
 CVs,  signed  and  dated  within  2  years  of  study  start  for  the  Investigator  and 
 Sub-Investigators; 
 3. 
 CV for the Study Coordinator, if applicable; 
 4. 
 Signed “Protocol Signature Page” by the Investigator and Sub-Investigators; 
 5. 
 Study Personnel Identification List; 
 6. 
 Training Log/Documentation; 
 7. 
 Written approval from the IRB of the Protocol and ICF (if necessary); and 
 8. 
 IRB Assurance of Compliance Form or equivalent (if applicable) 
 11.5  Protocol Adherence and Deviations 
 This  study  will  be  conducted  as  described  in  this  protocol.  Investigators  are  not  permitted  to 
 deviate  from  this  protocol  except  to  protect  subject  rights.  Any  deviations  from  this  protocol 
 must be documented by the Investigator. 
 A  protocol  deviation  is  any  noncompliance  with  the  clinical  study  protocol,  GCP,  or  SOP 
 requirements.  The  noncompliance  may  be  either  on  the  part  of  the  investigator,  or  study  site 
 staff. 
 All  deviations  must  be  addressed  in  study  source  documents  and  will  be  reviewed  during 
 routine  monitoring  visits.  Investigators  will  be  required  to  identify  preventive  and  corrective 
 actions  to  prevent  further  deviations.  An  Investigator  may  be  disqualified  from  the  study  for 
 repeated and/or egregious protocol deviations. 
 11.6  Publication and Data Sharing Policy 
 At  the  conclusion  of  the  study,  a  multi-center  article  may  be  prepared  for  publication  in  a 
 scientific  journal.  The  publication  of  the  principal  results  from  any  single-center  experience 
 within  the  study  is  not  allowed  until  the  preparation  and  publication  of  the  multi-center 
 results.  Exceptions  to  this  rule  require  the  prior  approval  of  Sponsor.  The  analysis  of  other 
 pre-specified  and  non-pre-specified  endpoints  will  be  performed  by  Sponsor  or  its  designee. 
 Such  analyses,  as  well  as  other  proposed  investigations  will  require  the  approval  of  Sponsor. 
 Sponsor  anticipates  the  possibility  of  secondary  manuscripts  with  principal  authorship.  For 
 purposes  of  timely  abstract  presentation  and  publication,  such  secondary  publications  will  be 
 delegated  to  the  appropriate  principal  authors,  and  final  analyses  and  manuscript  review  for 
 all multi-center data will require the approval of Sponsor. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  22 
 All  information  and  data  sent  to  Sponsor  or  an  authorized  designee  concerning  subjects  or 
 their  participation  in  the  study  will  be  considered  confidential.  All  data  used  in  the  analysis 
 and  reporting  of  this  study  will  be  used  in  a  manner  without  identifiable  reference  to  the 
 subject.  The  Investigator  consents  to  visits  by  personnel  of  Sponsor  and  its  affiliates  or 
 designees, as well as, FDA representatives. 
 The  final  contents  of  the  primary  manuscript  will  be  at  the  discretion  of  the  Sponsor.  Neither 
 the  complete  nor  any  part  of  the  results  of  the  study  carried  out  under  this  protocol,  nor  any 
 of  the  information  provided  by  the  Investigator  for  the  purposes  of  performing  the  study,  will 
 be  published  or  passed  on  to  any  third  party  without  the  consent  of  the  study  Sponsor.  Any 
 investigator  involved  with  this  study  is  obligated  to  provide  the  Investigator  with  complete 
 results and all data derived from the study. 
 12.  CLINICAL SITE MONITORING AND AUDIT 
 Clinical  site  monitoring  is  conducted  to  ensure  that  the  rights  of  subjects  are  protected, 
 that  the  reported  study  data  are  accurate,  complete,  and  verifiable,  and  that  the  conduct  of 
 the  study  is  in  compliance  with  the  currently  approved  protocol/amendment(s),  with  GCP, 
 and  with  applicable  regulatory  requirement(s).  A  Data  Safety  and  Monitoring  Board  has 
 been appointed for this study. Please see the attached Data Safety and Monitoring Plan. 
 The  site  may  be  subject  to  a  quality  assurance  audit  by  personnel  of  the  Sponsor  and/or  by 
 other Regulatory Authorities. 
 12.1  Site Initiation Visit 
 The  purpose  of  this  visit  is  to  review  with  the  Investigator  and  staff  the  provisions  and  proper 
 conduct  of  the  study.  This  includes  a  detail  review  of  the  protocol  and  eCRFs  with 
 instructions  as  to  their  completion,  as  well  as  reviewing  regulations  pertaining  to  the  conduct 
 of  the  clinical  study.  Arrangements  for  timely  and  accurate  reporting  of  clinical  data  will  be 
 established. The following will be reviewed during the Study Initiation Visit: 
 1.  If applicable, confirm that the ICF to be used is the one approved by IRB; 
 2.  Verify that all essential and necessary documents are on file at the site and at 
 Sponsor; and 
 3.  Arrange for Electronic Data Capture/eCRF training 
 12.2  Close-Out Visit 
 The  purpose  of  this  visit  is  to  collect  all  outstanding  study  data  documents,  confirm  that  the 
 Investigator’s  files  are  accurate  and  complete,  review  the  record  retention  requirements  with 
 the  Investigator  and  assure  that  all  applicable  requirements  for  closure  of  the  study  are  met. 
 The actions and observations made at this visit will be recorded and filed. 
 13.  REGULATORY AND ETHICAL CONSIDERATIONS 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  23 
 13.1  Ethical Standard 
 This  study  will  be  conducted  in  accordance  with  the  Declaration  of  Helsinki,  HIPAA 
 requirements,  GCP,  applicable  FDA  regulations  (21  CFR  parts  50,  54,  56),  and 
 ISO14155:2011. 
 13.2  Institutional Review Board Approval 
 Before  commencement  of  the  study,  the  Investigator  must  provide  Sponsor  with  written 
 documentation  of  IRB  approval.  This  approval  must  refer  to  the  ICF  (if  applicable)  and  the 
 study  by  both  the  title  and  the  protocol  number  assigned  by  Sponsor.  The  Investigator,  if  a 
 member  of  the  IRB,  is  not  to  participate  in  the  approval  decision  for  this  study.  This 
 non-participation should be noted in the approval letter. 
 The  IRB  must  give  written  renewal  of  the  original  approval  at  least  annually  to  continue  the 
 study. A copy of the written renewal must be provided to Sponsor. 
 13.3  Investigator Reports 
 Where  applicable,  the  investigator  should  submit  written  summaries  of  the  study’s  status  to 
 the  IRB  annually,  or  more  frequently,  if  requested  by  the  IRB.  The  investigator  should 
 promptly  provide  written  reports  to  the  Sponsor,  the  IRB  and,  where  applicable,  the 
 institution on any changes significantly affecting the conduct of the study. 
 Upon  completion  of  the  study,  the  investigator,  where  applicable,  should  inform  the 
 institution;  the  investigator/institution  should  provide  the  IRB  with  a  summary  of  the  study's 
 outcome.  Reporting  to  the  regulatory  authority  by  the  Sponsor  (if  applicable)  with  any 
 reports required. 
 13.4  Participant and Data Confidentiality 
 Subject  confidentiality  is  strictly  held  in  trust  by  the  participating  investigators,  their  staff, 
 and  the  Sponsor(s)  and  their  agents.  This  confidentiality  is  extended  to  cover  testing  of 
 biological  samples  and  genetic  tests  in  addition  to  the  clinical  information  relating  to 
 participants.  Therefore,  the  study  protocol,  documentation,  data,  and  all  other  information 
 generated  will  be  held  in  strict  confidence.  No  information  concerning  the  study,  or  the  data 
 will  be  released  to  any  unauthorized  third  party  without  prior  written  approval  of  the 
 Sponsor. 
 The  study  monitor,  other  authorized  representatives  of  the  Sponsor,  representatives  of  the 
 IRB  may  inspect  all  documents  and  records  required  to  be  maintained  by  the  Investigator, 
 including  but  not  limited  to,  medical  records  (office,  clinic,  or  hospital)  for  the  participants  in 
 this study. The clinical study site will permit access to such records. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC. 

 Bleep DreamPort-Eclipse 
 Version 1.1 
 Page  |  24 
 The  study  participant’s  contact  information  will  be  securely  stored  at  each  clinical  site  for 
 internal  use  during  the  study.  At  the  end  of  the  study,  all  records  will  continue  to  be  kept  in  a 
 secure location for as long a period as dictated by local IRB and applicable regulations. 
 13.5  Conflict of Interest Policy 
 The  independence  of  this  study  from  any  actual  or  perceived  influence  is  critical.  Therefore, 
 any  actual  conflict  of  interest  of  persons  who  have  a  role  in  the  design,  conduct,  analysis, 
 publication,  or  any  aspect  of  this  study  will  be  disclosed  and  managed.  Furthermore,  persons 
 who  have  a  perceived  conflict  of  interest  will  be  required  to  have  such  conflicts  managed  in  a 
 way  that  is  appropriate  to  their  participation  in  the  study.  The  study  leadership  has 
 established  policies  and  procedures  for  all  study  group  members  to  disclose  all  conflicts  of 
 interest  and  will  establish  a  mechanism  for  the  management  of  all  reported  dualities  of 
 interest. 
 14.  PREMATURE TERMINATION OR SUSPENSION OF STUDY 
 The  Sponsor  reserves  the  right  to  temporarily  suspend  enrollment  or  terminate  the  study  at 
 any  time  as  set  forth  in  the  Clinical  Study  Agreement.  Written  notice  documenting  the  reason 
 for  study  suspension  or  termination  will  be  submitted  to  the  Investigator  in  advance  of  such 
 termination.  If  the  study  is  prematurely  terminated  or  suspended,  the  Investigator  will 
 promptly inform the IRB and will provide the reason(s) for the termination or suspension. 
 The  Sponsor  may  suspend  enrollment  or  terminate  the  study  at  a  specific  site  for  reasons 
 including, but not limited to: 
 1.  Inadequate data collection 
 2.  Low subject enrollment rate 
 3.  Non-compliance with the protocol or other clinical research requirements 
 The  study  may  resume  once  concerns  about  protocol  compliance,  and/or  data  quality  are 
 addressed. 
 This document contains information that is the confidential and proprietary property of Bleep, LLC or its 
 affiliates. Neither this document nor the information therein may be reproduced, used, or disclosed to or for the 
 benefit of any third party without the prior consent of Bleep, LLC.