N/A
Completed N=187
Baseline Sleep Apnea Study #2
Obstructive Sleep Apnea of Adult
Source: ClinicalTrials.gov NCT04599803 ↗
Enrolled (actual)
187
Serious AEs
1.0%
Results posted
Oct 2022
Primary outcomePrimary: Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription — 7.4 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription |
7.4 | — |
| PRIMARY Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis |
13.9 | — |
| PRIMARY Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation |
8.1 | — |
| PRIMARY Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved |
37.5 | — |
| SECONDARY Completion Rates Among Individuals Who Had an HST Ordered |
153 | — |
| SECONDARY Completion Rates Among Individuals Prescribed a PAP Device |
103 | — |
| SECONDARY Percent of Participants Who Meet 90 Day Compliance Success Criteria |
68 | — |
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
Data sourced from ClinicalTrials.gov (NCT04599803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.