Clinical trial NCT04599803: Baseline Sleep Apnea Study #2
Official title: Baseline Sleep Apnea Study #2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription
timeFrame: 147 Days
measure: Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis
timeFrame: 164 days
measure: Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation
timeFrame: 153 Days
measure: Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved
timeFrame: 90 Days
Secondary outcomes:
measure: Completion Rates Among Individuals Who Had an HST Ordered
timeFrame: 161 Days
measure: Completion Rates Among Individuals Prescribed a PAP Device
timeFrame: 153 Days
measure: Completion Rates Among Individuals Prescribed a PAP Device
timeFrame: 90 Days
measure: Percent of Participants Who Meet 90 Day Compliance Success Criteria
timeFrame: 90 Days
Other outcomes:
Locations:
city: South San Francisco
country: United States
facility: Verily Life Sciences LLC
state: California
Study officials:
affiliation: Verily Life Sciences LLC
name: Shannon Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar S, Rudie E, Dorsey C, Blase A, Benjafield AV, Sullivan SS. Assessment of Patient Journey Metrics for Users of a Digital Obstructive Sleep Apnea Program: Single-Arm Feasibility Pilot Study. JMIR Form Res. 2022 Jan 12;6(1):e31698. doi: 10.2196/31698.