Baseline Sleep Apnea Study #2

Study Overview
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Brief Summary
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This is a single group, unblinded, prospective clinical study. 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.

Official Title
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Baseline Sleep Apnea Study #2

Conditions
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Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Device: Verily Sleep Apnea (VSA) Program/App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 or older Able to speak and read English Legal United States Resident with a Government Issued ID Participating in the Project Baseline Community Study Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form 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+ Own a computer with a web camera Consistent access to electricity and wifi for the duration of the study Have a high risk of OSA as determined by screening questionnaire Good candidate for PAP therapy, in the opinion of the managing clinician Without significant limitation in ability to participate in the study, in the opinion of the investigator. Exclusion Criteria: 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) 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) Sponsor employees and individuals working on Project Baseline Self reported to be pregnant or planning to become pregnant during the study period Current use of home oxygenation devices, such as supplemental oxygen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST) | Device: Verily Sleep Apnea (VSA) Program/App<br>* The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 is told they may have OSA to when they receive HST prescription | 147 Days | 
| Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis | Time from when the participant receives HST prescription to OSA diagnosis. | 164 days | 
| Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation | Time from OSA diagnosis to PAP therapy initiation. | 153 Days | 
| Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved | Time (number of days) from therapy initiation to when 90-day compliance threshold is achieved. 90-day Compliance is defined as ≥ 4 hours per night on 70% of nights during a consecutive 30 day period anytime during the first 90 days. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion Rates Among Individuals Who Had an HST Ordered | Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results. | 161 Days | 
| Completion Rates Among Individuals Prescribed a PAP Device | Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them). | 153 Days | 
| Completion Rates Among Individuals Prescribed a PAP Device | Percentage of individuals who used the PAP device at least once during the 90 days | 90 Days | 
| Percent of Participants Who Meet 90 Day Compliance Success Criteria | 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 | 90 Days |