Baseline Sleep Apnea Study #2
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Sponsor: Verily Life Sciences LLC

Cover Page
Protocol title
Baseline Sleep Apnea #2
Protocol number
102033
Rev/Date
Rev B, IRB approved 05/31/2020
Sponsor Name
Verily Life Sciences LLC
NCT#
NCT04599803
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CPR, Protocol, Baseline Sleep Apnea Study #2
Document Number
Study Title
Baseline Sleep Apnea Study #2
Protocol Number
Version
Sponsor Name
Verily Life Sciences LLC
Sponsor Address
Sponsor Contacts
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Protocol
Investigator’s Agreement Signature Page
I, Principal Investigator, agree to conduct this study in accordance with the International
Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP), applicable
legal and regulatory requirements, and in compliance with the provisions of this protocol.
I am responsible for ensuring that the investigation is conducted according to this protocol
and for protecting the rights, safety, and welfare of the research subjects. All personnel
involved in the conduct of this study will complete Human Subject Protection training.
I agree to ensure that all staff members involved in the conduct of this study are informed
about their obligations in meeting the above commitments.
Principal Investigator
Signature
Date
Conﬁdentiality Statement
The information in the following document is provided to you as an investigator, potential investigator, or
consultant, for review by you, your staff, and applicable Institutional Review Board, and is considered conﬁdential.
It is understood that the information will not be disclosed to others without written authorization from Verily Life
Sciences LLC, except to the extent necessary to obtain informed consent from those persons to whom the
product may be administered.
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Table of Contents
Protocol Summary
5
Summary of Changes
7
Prior Experience
8
Study Background and Rationale
8
Study Design
9
Study Objectives and Endpoints
9
Objectives(s)
9
Endpoint(s)
10
Overview
11
Sample Size and Number of Participating Sites
11
Inclusion Criteria
11
Exclusion Criteria
11
Discontinued/Withdrawal of Study Subjects
12
Study Assessment Plan and Methods
12
Schedule of Study Procedures Table
12
Study Conduct and Procedures
13
Recruitment
13
Screening/Screen Failures
13
Enrollment
14
Participant Compensation
14
Visit Schedule
14
Test Procedures and Data Collection
16
Self Reported Data
16
Sensor/Device/App Data
18
Risk Analysis
19
Risk Analysis
19
Beneﬁts
19
Risks
19
Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Problems
20
Adverse Events
21
Serious Adverse Events
21
Unanticipated Adverse Device Effects (UADE)
22
Device Deﬁciencies
22
Investigational Products
23
Investigational Product Description
23
Investigational Product Labeling & Accountability
23
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Regulatory, Ethical and Study Oversight Considerations
24
Regulatory and Ethical Considerations
24
Financial Disclosure
24
Informed Consent Process
24
Data Protection
25
Data Quality Assurance
25
Source Documents
25
Study and Site Closure
25
Publication Policy
26
Statistical Considerations
26
References
28
Glossary
28
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1.
Protocol Summary
Study Sponsor
Verily Life Sciences LLC
Study Description
This study seeks to understand patient diagnostic and treatment journey and positive
airway pressure (PAP) therapy compliance for Verily Sleep Apnea (VSA) program/app
users. Participants will enroll remotely and may undergo a home sleep test (HST). Upon
conﬁrmation of obstructive sleep apnea (OSA) and prescription of PAP therapy, the
participant will begin using the VSA app to supplement PAP treatment. After 90 days of
active participation, the participant will be given instructions for follow-up care, as
indicated.
This study will take a decentralized approach. Recruitment, enrollment, consultation,
testing, coaching and active participation with the VSA app will take place remotely.
Study Objectives
Primary:
●
To assess and quantify patient journey (e.g., time to diagnosis, time to initiate
therapy, patient satisfaction) for users of the VSA program
Secondary:
●
To assess patient journey completion rates for users of the VSA program
●
To assess and quantify PAP compliance in users of the VSA program
Study Endpoints
Primary
●
Time (number of days) from when participant is told they may have OSA to OSA
diagnosis
○
Time (number of days) from when participant is told they may have OSA to
when they receive HST prescription
○
Time (number of days) from when participant receives HST prescription to
when they receive their diagnosis
●
Time (number of days) from OSA diagnosis to PAP therapy initiation
●
Time (number of days) from therapy initiation to when 90-day compliance
threshold is achieved
Secondary
●
Completion rates
○
Among individuals who had an HST ordered, % of individuals who
completed the HST
○
Among individuals prescribed a PAP device, % of individuals who ﬁlled the
order (PAP device delivered to them)
○
Among individuals prescribed a PAP device, % of individuals who used the
PAP device at least once during the 90 days
●
Compliance Metrics
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○
Percent of participants who meet 90 day compliance success criteria, as
deﬁned by:
■
≥4 hours per night on 70% of nights during a consecutive 30 day
period anytime during the ﬁrst 90 days
Study Type
This is a single group, unblinded, prospective clinical study
Regulatory
Status/Trial
Classiﬁcation
Non-signiﬁcant risk (NSR)
Study Population
Approximately 50-200 individuals who have been screened and diagnosed with Obstructive
Sleep Apnea (OSA) during the study's initial screening and diagnostic process will be
enrolled as participants in the study. This study will enroll remotely to participants across
the United States.
The number of individuals who will have to be screened will be greater than the number
ultimately enrolled, i.e., greater than 50-200. The number of individuals who undergo the
screening process will depend on how many must be screened in order to identify the
requisite 50-200 subjects who meet the diagnostic and other criteria for enrollment.
Participant
Duration
For participants who are diagnosed with OSA and prescribed a PAP device, active
participation in the study after receiving the PAP device is expected to last approximately 3
months from receipt of the device. Active participation is deﬁned as using the PAP device
(PAP data collection) while completing the other study related activities (including VSA app
and console use, surveys/questionnaires, and interacting with optional Health Coaches)
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For participants who are diagnosed with OSA and prescribed a PAP device, total
participation may last for up to one (1) year, including screening, time to diagnosis, and PAP
data collection after active participation in the study has been completed.
Inclusion Criteria
1.
Ages 18 or older
2.
Able to speak and read English
3.
Legal United States Resident with a Government Issued ID
4.
Participating in the Project Baseline Community Study
5.
Demonstrates understanding of the study requirements and is able and willing to
sign the informed consent form
6.
Own a smartphone with a data plan and be the primary user of the smartphone;
smartphone must use Android Lollipop (5.1+/ API 22+) or iOS 11.X+
7.
Own a computer with a web camera
8.
Consistent access to electricity and wiﬁ for the duration of the study
9.
Have a high risk of OSA as determined by screening questionnaire
10. Good candidate for PAP therapy, in the opinion of the managing clinician
11. Without signiﬁcant limitation in ability to participate in the study, in the opinion of
the investigator.
Exclusion Criteria
1.
Previously diagnosed with sleep apnea or other sleep disorders, that in the opinion
of the investigator, makes the participant ineligible (e.g., Obstructive Sleep Apnea,
Central Sleep Apnea, Complex Sleep Apnea, chronic insomnia)
2.
Participant is a shift worker (indicated by having a night shift schedule on a regular
basis, or a work shift that changes or rotates on a daily, weekly, or monthly basis)
3.
Sponsor employees and individuals working on Project Baseline
4.
Self reported to be pregnant or planning to become pregnant during the study
period
5.
Current use of home oxygenation devices, such as supplemental oxygen
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7
3.
Prior Experience
4.
Study Background and Rationale
4.1.
Background
Obstructive sleep apnea (OSA) is a sleep breathing disorder that affects an estimated 54 million
Americans (calculated based on a 16-country prevalence data study),1,2 and is associated with
heart disease, stroke, type 2 diabetes and other life-threatening conditions. Despite the
condition’s high prevalence and increasing public awareness, past research has shown that
approximately 80 percent of individuals with OSA are undiagnosed,3 untreated and therefore
unaware of their own risk and of the beneﬁts that therapy could provide.
OSA presents to the patient most frequently as excessive daytime tiredness, increased lapses or
micro-sleeps during important activities such as driving, nighttime disturbances to bed partners
(largely through snoring or restlessness)4, and perhaps most importantly signiﬁcantly increased
risk and severity of multiple comorbidities including but not limited to cardiovascular disease
(CVD)5-6, type 2 diabetes (T2D)7, and mental health disorders8.
The diagnosis pathway for patients with OSA is often complex and diﬃcult for patients to
navigate, involving interactions with many different parties such as a primary care provider, sleep
labs, durable medical equipment companies, and insurance providers9. There exist opportunities
for better coordinating care and improving the patient experience in the diagnostic and treatment
pathways.
The gold standard treatment for OSA is the night-time use of a positive airway pressure (PAP)
device. PAP provides positive pressure to support a patent airway for patients who experience
clinically signiﬁcant frequency of apneas and/or hypopneas10. The PAP device consists of a
bedside powered device that pushes air through a ﬂexible tube to a mask worn either over the
mouth and nose or just the nose. This device is, as can readily be imagined, diﬃcult to introduce
into the patient’s bedtime routine, life, travel, etc. No other treatment or therapy for OSA has been
shown to be as effective as PAP11. Any method of increasing compliance with the patient’s
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prescribed therapy could thus decrease both the cost of care for relevant comorbidities as well as
signiﬁcantly improve the patient’s quality of life.
4.2.
Rationale
This study seeks to understand patient journey and PAP therapy compliance for Verily Sleep
Apnea (VSA) program users.
The VSA app is intended to help individuals who may have OSA go through the complex
diagnostic pathway more eﬃciently and virtually. The VSA app is also intended to help patients
who have been diagnosed with OSA to manage their therapy and is intended to facilitate a
program where users can possibly discover their potential risk for OSA through a clinically
validated questionnaire screener and consult with a healthcare professional.
The VSA app will also allow participants to message with Health Coaches who will provide
guidance related to sleep and OSA. Communication between the Health Coach and participant is
important in enhancing and promoting motivation for PAP adherence. The motivational
enhancement approach is a published behavioral intervention based on the principles of
motivational interviewing12.  Its fundamental premise is to honor the natural ambivalence that
accompanies any change to behavior and to approach the patient in a thoughtful and empathetic
manner that elicits critical thought - in order to maximize behavior change.
Technology, especially mobile technology, has the potential to provide new, easier to use, more
timely, and more scalable methods for helping patients discover their OSA risk, onboarding
patients with OSA to PAP treatment, as well as helping these patients to troubleshoot and make
progress in their OSA treatment.
5.
Study Design
5.1.
Study Objectives and Endpoints
5.1.1.
Objectives(s)
Primary:
●
To assess and quantify patient journey (e.g., time to diagnosis, time to initiate
therapy, patient satisfaction) for users of the VSA program
Secondary:
●
To assess patient journey completion rates for users of the VSA program
●
To assess and quantify PAP compliance in users of the VSA program
5.1.2.
Endpoint(s)
Primary
●
Time (number of days) from when participant is told they may have OSA to OSA
diagnosis
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○
Time (number of days) from when participant is told they may have OSA
to when they receive HST prescription
○
Time (number of days) from when participant receives HST prescription
to when they receive diagnosis
●
Time (number of days) from OSA diagnosis to PAP therapy initiation
●
Time (number of days) from therapy initiation to when 90-day compliance
threshold is achieved
Secondary
●
Completion rates
○
Among individuals who had an HST ordered, % of individuals who
completed the HST
○
Among individuals prescribed a PAP device, % of individuals who ﬁlled
the order (PAP device delivered to them)
○
Among individuals prescribed a PAP device, % of individuals who used
the PAP device at least once during the 90 days
●
Compliance Metrics
○
Percent of participants who meet 90 day compliance success criteria, as
deﬁned by:
■
≥4 hours per night on 70% of nights during a consecutive 30 day
period anytime during the ﬁrst 90 days
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5.2.
Overview
This is a single group, unblinded, prospective clinical study to understand the patient diagnostic
and treatment journey and PAP therapy compliance for Verily Sleep Apnea (VSA) program users.
Participants will enroll remotely and if deemed clinically appropriate will undergo a commercially
available and approved home sleep test (HST). Upon conﬁrmation of OSA, the participant will
begin using the VSA app to supplement PAP treatment. After 90 days of active participation or in
the event of earlier departure from the study, the participant will be given instructions for
follow-up care, as indicated. Participants will lose access to the VSA app at the end of the 90 day
period.
This study will take a decentralized approach. Recruitment, enrollment, consultation, coaching
and active participation with the VSA app will take place remotely.
5.3.
Sample Size and Number of Participating Sites
The study plans to enroll approximately 50-200 individuals that will be diagnosed with Obstructive
Sleep Apnea (OSA) and begin PAP therapy, as part of the study procedures. This study will enroll
remotely to participants across the United States.
5.4.
Inclusion Criteria
1.
Ages 18 or older
2.
Able to speak and read English
3.
Legal United States Resident with a Government Issued ID
4.
Participating in the Project Baseline Community Study
5.
Demonstrates understanding of the study requirements and is able and willing to sign the
informed consent form
6.
Own a smartphone with a data plan and be the primary user of the smartphone;
smartphone must use Android Lollipop (5.1+/ API 22+) or iOS 11.X+
7.
Own a computer with a web camera
8.
Consistent access to electricity and wiﬁ for the duration of the study
9.
Have a high risk of OSA as determined by screening questionnaire
10. Good candidate for PAP therapy, in the opinion of the managing clinician
11. Without signiﬁcant limitation in ability to participate in the study, in the opinion of the
investigator.
5.5.
Exclusion Criteria
1.
Previously diagnosed with sleep apnea or other sleep disorders, that in the opinion of the
investigator, makes the participant ineligible (e.g., Obstructive Sleep Apnea, Central Sleep
Apnea, Complex Sleep Apnea, chronic insomnia)
2.
Participant is a shift worker (indicated by having a night shift schedule on a regular basis,
or a work shift that changes or rotates on a daily, weekly, or monthly basis).
3.
Sponsor employees and individuals working on Project Baseline
4.
Self reported to be pregnant or planning to become pregnant during the study period
5.
Current use of home oxygenation devices, such as supplemental oxygen
5.6.
Discontinued/Withdrawal of Study Subjects
Participation in this research study is voluntary and participants may withdraw at any time. In the
event the participant chooses to withdraw, he/she will be instructed to contact the Investigator
immediately and will be asked the reason for their withdrawal from the study.
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The participant may also be discontinued from the research study at any time if the Investigator
considers it to be in his/her best medical interest. The Investigator may withdraw the participant
any time due to the non-compliance with respect to the provisions of the protocol. If a participant
withdraws prior to study completion, no new health information identifying him/her will be
gathered after that date. Information that has been gathered may still be used and given to
others.
If an enrolled participant withdraws or is discontinued prior to completing all study activities, a
new, qualiﬁed candidate may be enrolled in the study to compensate for the incomplete data set.
Participants will either satisfactorily complete all requirements set forth in the protocol or their
participation in the clinical study will be prematurely terminated. The completion of a participant’s
participation in the study or early departure from the study, including reasons for early
discontinuation, will be fully documented on the appropriate case report form and an effort will be
made to connect them with a local clinician for post-study consultation, instructions and, if
indicated, recommendations for follow-up care.
6.
Study Assessment Plan and Methods
6.1.
Schedule of Study Procedures Table
Table 1. Schedule of Study Procedures
Procedures
Remote
Screening
Activities
Self
Complete
Activities
Remote
Clinician
Consult 1
Remote
Clinician
Consult 2
Remote
Health
Coach
Interactions
Remote
Supplem-
ental
Visit(s)
Eligibility
✓
✓a
Informed Consent
✓
✓a
ID Veriﬁcation
✓
✓a
Validated Tools
✓
Non-Validated
Surveys/
Questionnaires
✓
Register for Verily
Sleep Apnea (VSA)
app/program
✓
Medical and Sleep
History
Questionnaire
✓
OSA Diagnostic
Consult with
Evaluating Clinician
✓
Home Sleep Test
(HST)
✓b
✓b
Ship HST
✓
PAP Therapy
✓
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Prescribed with
Managing Clinician
Verily Sleep Apnea
(VSA) program PAP
Therapy On-Boarding
✓
Remote Interview
✓
✓
Compliance
monitoring/outreach
✓
✓
✓
90-Day Compliance
Check
✓
✓
Adverse Event
Evaluation
✓
✓
✓
✓
✓
✓
Protocol Deviation
Assessment
✓
✓
✓
✓
✓
✓
Study Exit
✓
a Administered if new version of the Informed Consent Form is released that impacts currently enrolled
participants
b HST may be administered more than once if test results are inconclusive
6.2.
Study Conduct and Procedures
The study is conducted in accordance with this clinical investigational plan and ethical principles
consistent with GCP and applicable regulatory requirements to protect the rights, safety, and
well-being of the study participants.
Prior to any study-related procedures, informed consent must be obtained.
6.2.1.
Recruitment
Participants will be recruited through a variety of methods such as IRB-approved
advertisements, registries, care provider recommendation, and community events. All
volunteers will be directed to visit the Project Baseline website or a study phone line to
learn more about the study. Volunteers can express an interest in joining the Baseline
Sleep Apnea Study #2 by visiting the Project Baseline website
(www.projectbaseline.com) and enrolling in the Project Baseline Community Study. The
study may also be referred to as “Baseline Sleep Apnea Study”, “Sleep Apnea Study #2”,
or “Sleep Apnea Study” on some recruitment material and other participants facing
material.
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6.2.2.
Screening/Screen Failures
Participants will be screened through the Project Baseline Community Study through data
collection deﬁned in that protocol. Participants enrolled in the Project Baseline
Community Study will complete survey questions used to assist with screening and
enrollment (such as demographics) into the Baseline Sleep Apnea Study #2.
Participants who consented to participate in the Baseline Remote Health Study but do
not meet one or more criteria required for participation in the study during screening will
be considered screen failures.
This data will be documented on the appropriate case report form.
6.2.3.
Enrollment
Participants who are enrolled in the Project Baseline Community Study may be enrolled in
the Baseline Sleep Apnea Study #2 based on an assessment of the study eligibility and
selection criteria. Study personnel will be provided with guidance regarding participant
eligibility for study enrollment. Target distribution will be based on demographics (e.g.
age, gender, socioeconomic status).
Participants who qualify for the study will be notiﬁed via the Member Portal, Verily Sleep
Apnea (VSA) app, email, mail, phone, text, or other methods that they are eligible to
participate. Participants will be considered enrolled in the study when they have signed
the IRB approved Informed Consent documents and are determined to meet all eligibility
criteria.
6.2.4.
Participant Compensation
Participants may be incentivized for enrolling in the study. Participants will be
compensated as described in the IRB-approved Informed Consent Form.
6.2.5.
Visit Schedule
The Baseline Sleep Apnea Study #2 participant journey includes:
●
Remote Screening Activities
●
Self Complete Activities
Remote Screening Activities
Participants that appear to qualify for the Baseline Sleep Apnea Study #2 will be invited to
complete remote screening activities. Proof of identity will be required prior to
enrollment. Before enrollment and engaging in any study activities, participants will be
asked to sign the IRB-approved electronic Informed Consent Form. Consent will be
obtained by the Investigator or his/her delegate, if applicable by state law. An individual is
considered to be enrolled in the study upon signature of the consent and conﬁrmation of
all eligibility criteria. All participants will be given a signed copy of the consent, or sent
one via the Member Portal, email, mail, or other methods.
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All consented participants in the Baseline Sleep Apnea Study #2 will be asked to undergo
the assessments outlined in the Schedule of Study Procedures Table(s) and Test
Procedures sections of the protocol.
Self Complete Activities
All consented participants in the Baseline Sleep Apnea Study #2 will be asked to undergo
the self-completed activities outlined in the Schedule of Study Procedures Table(s) and
Test Procedures sections of the protocol.
Compliance with self-complete activities will be assessed throughout the study and
participants will receive targeted reminders about activities that need to be completed.
Remote Supplemental Visit(s) and Study Exit
Participants who do not complete study activities within the requested time frame may
be contacted throughout the study duration to attend a supplemental remote visit. During
these visits, additional interviews/surveys may be deployed to help understand issues,
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non-compliance and improve compliance moving forward. The study team may also
review device/app setup and troubleshooting to help participants if they become stuck.
Additionally, the study team may reach out to the participant throughout the duration of
the study via phone or email for troubleshooting.
The study team reserves the right to update the VSA app as needed throughout the
course of the study (e.g., to ﬁx newly discovered bugs within the app). A supplemental
visit may be scheduled to review changes associated with app updates.
Once a participant exits the study, either from early exit or completion of study-related
activities, an effort will be made to connect them with a managing physician for
post-study consultation, instructions and, if indicated, recommendations for follow-up
care.  The exit workﬂow will be designed in consultation with the Principal Investigator on
this study and with the partnering physician based on clinical best practices.  For
example, the exit workﬂow includes an attempt by the managing physician to reach out to
the participant’s primary care provider to inform them of the study and to provide clinical
recommendations.  Upon exiting the study, participants will also be provided with key
data collected during the study in an "Exit Packet", such as their Sleep Report and
prescription for PAP therapy. A supplemental visit may be scheduled for ﬁnal instruction
and recommendations for follow-up care.
Participants will lose access to the VSA app after 90 days of active participation has
ended.
6.3.
Test Procedures and Data Collection
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7.
Risk Analysis
7.1.
Risk Analysis
Verily Life Sciences has conducted an analysis of the beneﬁts and risks of the VSA app.
Verily Life Sciences has determined that this clinical investigation is justiﬁed as the overall
potential beneﬁt to the population outweighs its risks.
7.2.
Beneﬁts
Participants at risk of having OSA will have the opportunity to go through the OSA diagnostic
pathway and use a PAP device (if prescribed) at no cost to them.
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There are no other beneﬁts to the participants for participating in this study, but the information
obtained will be used in scientiﬁc research and may be helpful to others in the future.
7.3.
Risks
The VSA app is intended to facilitate an Obstructive Sleep Apnea (OSA) management program. It
is intended to improve the lives of patients who have been diagnosed with OSA to help manage
their therapy and is intended to facilitate a program where users can possibly discover their
potential risk for OSA.
The types of potential risk the volunteer research participants will encounter with the VSA app
are related to risks for releasing participant/patient private health information.  The participant
proﬁle in the VSA app will include personal information including name, contact information, and
health information, including PAP usage data. All data sent from the VSA app are encrypted.
Information collected during interviews from study participants will be kept conﬁdential
throughout the study. A unique subject identiﬁcation code will be used when collecting data on
standardized paper or electronic Case Report Forms (CRF/eCRF). Only study team members
trained on the clinical study will have access to the study records. If a participant agrees to
participate in the study, Verily will store the data collected on Google servers. This data will be
restricted to authorized study personnel and access is audited to ensure the privacy of this data.
All data used in the analysis and reporting of this study will be used in a manner without
identiﬁable reference to the study participants.
Though PAP is part of the participants’ clinical care prescribed by their clinician, for purposes of
completeness, potential adverse effects of PAP follow.
1.
Skin irritation or rashes
2.
Feelings of claustrophobia when wearing mask
3.
Dry mouth, throat, or nose after wearing the mask
4.
Temporary marks on the skin
5.
Diﬃculty sleeping in the ﬁrst few weeks of treatment
6.
Increased daytime sleepiness in the ﬁrst few weeks of treatment
7.
Bloating
8.
Eye irritation
9.
Ear or sinus discomfort
Adverse effects/discomfort associated with using PAP and related supplies are considered
anticipated and will not be recorded as an adverse event.
Though the HST is part of the participants’ clinical care prescribed by their clinician, for purposes
of completeness, potential adverse effects of HST follow:
1.
Skin irritation
2.
Rash
3.
Allergic reaction
4.
Mild discomfort
Adverse effects/discomfort associated with using an HST and related supplies are considered
anticipated and will not be recorded as an adverse event.
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There may also be other side effects of participating in this study that are not known at this time.
8.
Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Problems
During and following a subject's participation in the study, the investigator/institution should ensure that
adequate medical care is provided to a subject for any adverse events related to the trial. The
investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of
which the investigator becomes aware.
In the event medical care to a subject is required, the medical care given to, and medical decisions made
on behalf of, subjects should always be the responsibility of a qualiﬁed physician.
8.1.
Adverse Events
An Adverse Event (AE) is deﬁned as any untoward medical occurrence, unintended disease or
injury in subjects, users or other persons, that is considered a change from baseline or pre-study
status, whether or not related to the investigational medical device.
Any pre-existing medical conditions or symptoms present in a participant will not be considered
an Adverse Event in this study, unless it worsens as a result of this study.
Only health events that are directly related to the VSA app or study procedures will be recorded as
adverse events.
Adverse events related to commercially available FDA-regulated (i.e., cleared or approved)
medical devices (such as PAP, HST and associated supplies) will not be recorded as adverse
events. Anticipated AEs related to the commercially available FDA-regulated devices include the
following:
1.
Skin irritation or rashes
2.
Feelings of claustrophobia when wearing mask
3.
Dry mouth, throat, or nose after wearing the mask
4.
Temporary marks on the skin
5.
Diﬃculty sleeping in the ﬁrst few weeks of treatment
6.
Increased daytime sleepiness in the ﬁrst few weeks of treatment
7.
Bloating
8.
Eye irritation
9.
Ear or sinus discomfort
10. Allergic reaction
11. Mild discomfort
All Adverse Events (AEs) will be reported on an AE Case Report Form and will include the
following: Date/time of onset, description of the event, the duration of the event, the severity of
the event, assessment of the relation of the event to the study device and procedure, description
of action taken (if any) and the event outcome.
In the event medical care to a subject is required, the medical care given to, and medical
decisions made on behalf of, subjects should always be the responsibility of a qualiﬁed physician.
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8.2.
Serious Adverse Events
A Serious Adverse Event (SAE) is deﬁned as an adverse event that is anticipated or unanticipated
and which reasonably suggests that one of the manufacturers’ devices has or may have caused
or contributed to a death or serious injury.
A Serious Adverse Event is an Adverse Event that led to: (a) death, (b) serious deterioration in the
health of the subject that either resulted in a (i) life-threatening illness or injury or (ii) permanent
impairment of a body structure or a body function, or (iii) in-patient or prolonged hospitalization or
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent
impairment to a body structure or a body function or (c) fetal distress, fetal death or a congenital
abnormality or birth defect.
A planned hospitalization for a pre- existing condition is not considered a SAE.
These events are typically reportable to health authorities. Serious Adverse Events must be
reported to the sponsor within 24 hours of knowledge of the event.
8.3.
Unanticipated Adverse Device Effects (UADE)
An Unanticipated Adverse Device Effect (UADE) is a serious adverse effect on health or safety or
any life-threatening problem or death caused by, or associated with, a device, if that effect or
problem was not previously identiﬁed in nature, severity, or degree of incidence in the
investigational plan or application (including a supplementary plan or application), or any other
unanticipated serious problem associated with a device that relates to the rights, safety, or
welfare of subjects. Anticipated potential adverse device effects have been identiﬁed in the
sponsor Risk Management ﬁles and/or product labeling.
The Principal Investigator will assure that all unanticipated adverse device effect (UADE) involving
risk to subjects or others will be reported to the sponsor within 24 hours of knowledge of event.
All UADE’s will be evaluated and the results of such evaluation will be reported to the IRB within
ten (10) working days after the event is reported by the study subjects. The sponsor will report all
SAE’s and UADE’s to the appropriate regulatory authority. All Serious and Unanticipated Adverse
Effects will be reviewed by a Medical Monitor.
9.
Device Deﬁciencies
The VSA app is an NSR device, but since the device does not diagnose or provide therapy, no device
deﬁciencies are anticipated.
Software bugs within the VSA app, either found by the study team or reported by the participant will not
be considered a device deﬁciency.
If, at any time during the study, the participant’s Smartphone (where the VSA app is installed) physically
breaks, or malfunctions, or the VSA app ceases to function or gives unexpected or erroneous information,
participants will be instructed to stop using the VSA app and contact the study team. If the participant
has another compatible Smartphone, instructions on installing the VSA app on a different Smartphone
will be provided and the participants will be instructed on how to remove the VSA app on the ﬁrst
Smartphone (if applicable).
If, at any time during the study, a commercially available (i.e., FDA cleared or approved) device (PAP and
associated supplies) physically breaks, or malfunctions, or gives unexpected or erroneous information,
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participants will be instructed to contact their DME provider. The DME provider may provide a
replacement device or repairs at the sponsor’s discretion. Alternatively, the sponsor may choose to exit
the participant without providing a replacement device.
The sponsor will not provide maintenance or support for any commercially available (i.e., FDA cleared or
approved) devices (PAP and associated supplies). If a participant reports a device malfunction and/or
device complaint to the sponsor support team (Verily User Success), the participant will be instructed to
contact their DME provider.
The sponsor support team may contact study participants during study participation in order to
troubleshoot issues with the VSA app, such as issues logging in or the app crashing.
10.
Investigational Products
10.1.
Investigational Product Description
The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.
10.2.
Investigational Product Labeling & Accountability
The Investigator should take adequate precautions, including access to the Investigational
product to prevent diversion of the VSA app into unauthorized channels of distribution.
The VSA app is classiﬁed as a Mobile Medical App (per FDA Guidance Policy for Device Software
Functions and Mobile Medical Applications issued September 2019) under enforcement
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discretion. The VSA appwill be labeled with the following: “CAUTION--Investigational device.
Limited by Federal (or United States) law to investigational use.”
Only Institutions/Investigators participating in the clinical study will be eligible to receive the VSA
app and can be used only when the following has been received:
●
Curriculum Vitae of the Investigator
●
A signed Investigator Agreement
●
Institutional Review Board (IRB) approval
●
IRB-approved Informed Consent Form
11.
Regulatory, Ethical and Study Oversight Considerations
11.1.
Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:
●
Consensus ethical principles derived from international guidelines including the
Declaration of Helsinki
●
Applicable ICH Good Clinical Practice (GCP) Guidelines
●
Applicable laws and regulations
The protocol, protocol amendments, ICF, and other relevant documents (eg, advertisements)
must be submitted to an IRB/IEC by the investigator and reviewed and approved by the IRB/IEC
before the study is initiated.
Any amendments to the protocol will require IRB/IEC approval before implementation of changes
made to the study design, except for changes necessary to eliminate an immediate hazard to
study participants.
The investigator will be responsible for the following:
●
Providing written summaries of the status of the study to the IRB/IEC annually or more
frequently in accordance with the requirements, policies, and procedures established by
the IRB/IEC
●
Notifying the IRB/IEC of SAEs or other signiﬁcant safety ﬁndings as required by IRB/IEC
procedures; and
●
Providing oversight of the conduct of the study at the site and adherence to requirements
of 21 CFR, ICH guidelines, the IRB and all other applicable local regulations
11.2.
Financial Disclosure
Investigators and sub-investigators will provide the sponsor with suﬃcient, accurate ﬁnancial
information as requested to allow the sponsor to submit complete and accurate ﬁnancial
certiﬁcation or disclosure statements to the appropriate regulatory authorities, as appropriate.
Investigators are responsible for providing information on ﬁnancial interests during the course of
the study and for 1 year after completion of the study.
11.3.
Informed Consent Process
Potential participants will be presented with the Baseline Sleep Apnea Study #2 eICF on the
Baseline Sleep Apnea Study #2 Web Portal..
Participants must be informed that their participation is voluntary. Participants will be required to
sign a statement of informed consent that meets the requirements of 21 CFR 50, local
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regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA)
requirements, where applicable, and the IRB.
If the potential participant agrees to the terms described in the Baseline Sleep Apnea Study #2
eICF and provides consent, study eligibility will be further assessed.
11.4.
Data Protection
Participants will be assigned a unique identiﬁer by the sponsor. Any participant records or
datasets that are transferred to the sponsor will contain the identiﬁer only; participant names or
any information which would make the participant identiﬁable will not be transferred.
The participant must be informed that his/her personal study-related data will be used by the
sponsor in accordance with local data protection law. The level of disclosure must also be
explained to the participant. All data used in the analysis and reporting of this evaluation will be
used in a manner without identiﬁable reference to the study participant.
11.5.
Data Quality Assurance
●
All participant data relating to the study will be recorded on printed or electronic CRF
unless transmitted to the sponsor or designee electronically (e.g. laboratory data). The
Investigator (or designee) is responsible for verifying that data entries are accurate and
correct by physically or electronically signing the CRF.
●
The investigator must maintain accurate documentation (source data).
●
The investigator must permit study-related monitoring, audits, IRB review, and regulatory
agency inspections and provide direct access to source data.
●
Monitoring details describing strategy (e.g. risk-based initiatives in operations and quality
such as Risk Management and Mitigation Strategies and Analytical Risk-Based
Monitoring), methods, responsibilities and requirements, including handling of
noncompliance issues and monitoring techniques (central, remote, or on-site monitoring)
are provided in the Monitoring Plan.
●
The sponsor or designee is responsible for the data management of this study including
quality checking of the data.
●
The sponsor assumes accountability for actions delegated to other individuals (e.g.
Contract Research Organizations).
●
Records and documents, including signed ICFs, pertaining to the conduct of this study
must be retained by the investigator for a minimum of [2] years after study completion
unless local regulations or institutional policies require a longer retention period. No
records may be destroyed during the retention period without the written approval of the
sponsor. No records may be transferred to another location or party without written
notiﬁcation to the sponsor.
11.6.
Source Documents
●
Source documents provide evidence for the existence of the participant and substantiate
the integrity of the data collected.
●
If study data is recorded directly on the CRFs/eCRFs (i.e., no prior written or electronic
record of data), it is considered to be source data.
●
All data will be entered directly into the eCRF, ePRO, and eICF.
●
Deﬁnition of what constitutes source data can be found in CRF completion guidelines.
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11.7.
Study and Site Closure
The sponsor designee reserves the right to close the study site (decentralized) or terminate the
study at any time for any reason at the sole discretion of the sponsor. Study sites will be closed
upon study completion. A study site is considered closed when all required documents and study
supplies have been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time, provided there is reasonable cause
and suﬃcient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the sponsor or investigator may include but are
not limited to:
●
Failure of the investigator to comply with the protocol, the requirements of the IRB or
local health authorities, the sponsor's procedures, or GCP guidelines
●
Inadequate recruitment of participants by the investigator
11.8.
Publication Policy
●
The results of this study may be published or presented at scientiﬁc meetings. If this is
foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor
before submission. This allows the sponsor to protect proprietary information and to
provide comments.
●
The sponsor will comply with the requirements for publication of study results. In
accordance with standard editorial and ethical practice, the sponsor will generally
support publication of multisite studies only in their entirety and not as individual site
data. In this case, a coordinating investigator will be designated by mutual agreement.
12.
Statistical Considerations
The study plans to enroll approximately 50-200 individuals that will be diagnosed with Obstructive Sleep
Apnea (OSA) and begin PAP therapy, as part of the study procedures.  It is recognized that the sample
size achieved in this baseline study will likely be insuﬃcient for statistical hypothesis testing, but it will
still be useful for establishing a baseline understanding of the performance of the VSA program.  The
primary endpoints of interest are ﬁve timelines relating to the patient diagnostic and treatment journey:
●
Time (number of days) from when participant is told they may have OSA to OSA diagnosis
○
Time (number of days) from when participant is told they may have OSA to when they
receive HST prescription
○
Time (number of days) from when participant receives HST prescription to OSA
diagnosis
●
Time (number of days) from OSA diagnosis to PAP therapy initiation
●
Time (number of days) from therapy initiation to when 90-day compliance threshold is achieved
Each of these will be reported as a point estimate accompanied by a conﬁdence interval.  These will be
calculated from the average and standard deviation of these timeframes across all participants.
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●
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13.
References
1.
Types of Sleep-Disordered Breathing. ResMed.
https://www.resmed.com/ap/en/healthcare-professional/diagnosis-and-treatment/sleep-disor
dered-breathing/types-of-sleep-disordered-breathing.html. Accessed September 6, 2019.
2.
Spicuzza, Lucia, et al. “Obstructive Sleep Apnoea Syndrome and Its Management.” Therapeutic
Advances in Chronic Disease, vol. 6, no. 5, 2015, pp. 273-285.,
doi:10.1177/2040622315590318.
3.
Eckert DJ, Jordan AS, Merchia P, Malhotra A. Central sleep apnea: Pathophysiology and
treatment. Chest. 2007;131(2):595–607. doi:10.1378/chest.06.2287
4.
Senaratna, Chamara V., et al. “Prevalence of Obstructive Sleep Apnea in the General
Population: A Systematic Review.” Sleep Medicine Reviews, vol. 34, Aug. 2017, pp. 70–81,
10.1016/j.smrv.2016.07.002.
5.
Bonsignore, Maria R., et al. “Obstructive Sleep Apnea and Comorbidities: A Dangerous Liaison.”
Multidisciplinary Respiratory Medicine, vol. 14, no. 1, 14 Feb. 2019,
10.1186/s40248-019-0172-9.
6.
Franklin, Karl A, and Eva Lindberg. “Obstructive Sleep Apnea Is a Common Disorder in the
Population-a Review on the Epidemiology of Sleep Apnea.” Journal of Thoracic Disease, vol. 7,
no. 8, 2015, pp. 1311–22, www.ncbi.nlm.nih.gov/pmc/articles/PMC4561280/,
10.3978/j.issn.2072-1439.2015.06.11.
7.
Kim, Richard D., et al. “An Economic Evaluation of Home Versus Laboratory-Based Diagnosis of
Obstructive Sleep Apnea.” Sleep, vol. 38, no. 7, 1 July 2015, pp. 1027–1037,
10.5665/sleep.4804. Accessed 31 July 2019.
8.
Semelka, Michael, et al. “Diagnosis and Treatment of Obstructive Sleep Apnea in Adults.”
American Family Physician, vol. 94, no. 5, 2016, pp. 355–360,
www.aafp.org/afp/2016/0901/p355.html.
9.
Rahaghi F, Basner RC. Delayed Diagnosis of Obstructive Sleep Apnea: Don't Ask, Don't Tell.
Sleep Breath. 1999;3(4):119-124.
10. Aurora, R. Nisha, et al. ""Quality measures for the care of adult patients with obstructive sleep
apnea."" Journal of clinical sleep medicine: JCSM: oﬃcial publication of the American
Academy of Sleep Medicine 11.3 (2015): 357.
11. Patil, S. P., Ayappa, I. A., Caples, S. M., Kimoff, R. J., Patel, S. R., & Harrod, C. G. (2019).
Treatment of adult obstructive sleep apnea with positive airway pressure: an American
Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.
Journal of Clinical Sleep Medicine, 15(02), 301-334.
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12. J.P. Bakker, T.E. Weaver, S. Parthasarathy, M.S. Aloia (2019). Adherence to CPAP: What should
we be aiming for, and how can we get there?. Chest, 155(6), 1272-1287.
14.
Glossary
Term
Abbr.
Deﬁnition
Adverse Event
AE
Any untoward medical occurrence, unintended disease or injury in
subjects, users or other persons, that is considered a change from
baseline or pre-study status, whether or not related to the investigational
medical device.
Case Report Form
CRF
A set of documents, designed for complete recording of all relevant
participant and device related data, as required by the clinical
investigation plan.
Clinical
Investigation
N/A
Any controlled systematic study in human participants, undertaken to
verify the safety and performance of a speciﬁc medical device, under
normal conditions of use. This is also known as a Clinical Study or
Clinical Trial.
Informed Consent
IC
A process by which a participant voluntarily conﬁrms his or her
willingness to participate in a particular trial, after having been informed
of all aspects that are relevant to the participant's decision, including
potential risks and beneﬁts to participate. Informed consent is
documented by means of a written, signed, and dated informed consent
form. Informed consent continues throughout the trial.
Investigational
Device
N/A
Any medical device intended for use by an appropriately qualiﬁed
practitioner when conducting clinical investigations in an adequate
clinical environment.
Principal
Investigator
PI
The investigator responsible for the conduct of a clinical investigation
and who takes the clinical responsibility for the well being of the
subjects/participants involved.
Serious Adverse
Event
SAE
A Serious Adverse Event (also referred to as Adverse Incident) is deﬁned
as an adverse event that is anticipated or unanticipated and that
reasonably suggests that one of the manufacturers devices has or may
have caused or contributed to a death or serious injury. A Serious Adverse
Event is an Adverse Event that led to: (a) death, (b) serious deterioration
in the health of the subject that either resulted in a (i) life-threatening
illness or injury or (ii) permanent impairment of a body structure or a body
function, or (iii) in-patient or prolonged hospitalization or (iv) medical or
surgical intervention to prevent life-threatening illness or injury or
permanent impairment to a body structure or a body function or (c) fetal
distress, fetal death or a congenital abnormality or birth defect. These
events are typically reportable to health authorities.
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Sponsor
N/A
An individual or an organization which takes responsibility for the
initiation and/or implementation of a clinical investigation.
Sub-Investigator
Sub-I
A member of the clinical study team with appropriate credentials and is
supervised by the Principal Investigator at a site and allowed to perform
critical trial-related procedures and/or to make key trial-related decisions.
Participant (also
referred to as
“Subject”)
N/A
A human being, either a patient or a non-patient volunteer, participating in
a clinical investigation.
Unanticipated
Adverse Device
Effect
UADE
Serious adverse effect on health or safety or any life-threatening problem
or death caused by, or associated with, a device, if that effect or problem
was not previously identiﬁed in nature, severity, or degree of incidence in
the investigational plan or application (including a supplementary plan or
application), or any other unanticipated serious problem associated with
a device that relates to the rights, safety, or welfare of subjects.
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