Baseline Sleep Apnea Study #2

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-08

Study Completion Date

2021-03-30

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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea of Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm 1

Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)

Group Type EXPERIMENTAL

Verily Sleep Apnea (VSA) Program/App

Intervention Type DEVICE

The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.

Interventions

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Verily Sleep Apnea (VSA) Program/App

The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No