Skip to main content
OpenTrials
Completed

NCT Number: NCT04599803

Baseline Sleep Apnea Study #2

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea of Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Verily Life Sciences LLC

South San Francisco, California, 94080, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verily Sleep Apnea (VSA) Program/App

Device

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

Primary outcomes

  1. Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription

    Time frame: 147 Days

    Time (number of days) from when participant is told they may have OSA to when they receive HST prescription

  2. Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis

    Time frame: 164 days

    Time from when the participant receives HST prescription to OSA diagnosis.

  3. Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation

    Time frame: 153 Days

    Time from OSA diagnosis to PAP therapy initiation.

  4. Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved

    Time frame: 90 Days

    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.

Secondary outcomes

  1. Completion Rates Among Individuals Who Had an HST Ordered

    Time frame: 161 Days

    Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.

  2. Completion Rates Among Individuals Prescribed a PAP Device

    Time frame: 153 Days

    Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them).

  3. Completion Rates Among Individuals Prescribed a PAP Device

    Time frame: 90 Days

    Percentage of individuals who used the PAP device at least once during the 90 days

  4. Percent of Participants Who Meet 90 Day Compliance Success Criteria

    Time frame: 90 Days

    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

Sponsors and collaborators

Lead sponsor

Verily Life Sciences LLC

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2020
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.