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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Device: Verily Sleep Apnea (VSA) Program/App

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • South San Francisco, California, United States, 94080
      • Verily Life Sciences LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)	Device: Verily Sleep Apnea (VSA) Program/App; The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription	Time (number of days) from when participant is told they may have OSA to when they receive HST prescription	147 Days
Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis	Time from when the participant receives HST prescription to OSA diagnosis.	164 days
Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation	Time from OSA diagnosis to PAP therapy initiation.	153 Days
Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved	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.	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rates Among Individuals Who Had an HST Ordered	Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.	161 Days
Completion Rates Among Individuals Prescribed a PAP Device	Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them).	153 Days
Completion Rates Among Individuals Prescribed a PAP Device	Percentage of individuals who used the PAP device at least once during the 90 days	90 Days
Percent of Participants Who Meet 90 Day Compliance Success Criteria	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	90 Days

Collaborators and Investigators

• Sponsor: Verily Life Sciences LLC
• Investigators: Principal Investigator: Shannon Sullivan, MD, Verily Life Sciences LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2020
• Primary Completion (ACTUAL): March 30, 2021
• Study Completion (ACTUAL): March 30, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (ACTUAL): October 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 102033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No