Baseline Sleep Apnea Study #2

Verily Life Sciences

Status

Completed

Conditions

Obstructive Sleep Apnea of Adult

Treatments

Device: Verily Sleep Apnea (VSA) Program/App

Study type

Interventional

Funder types

Industry

Identifiers

NCT04599803

102033

Details and patient eligibility

About

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.

Enrollment

187 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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