Baseline Sleep Apnea Study #2

NCT04599803 | Completed Results FDA Device

• 1 other identifier: 102033
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Completion Rates Among Individuals Who Had an HST Ordered

  161 Days

• Completion Rates Among Individuals Prescribed a PAP Device

  153 Days

• Completion Rates Among Individuals Prescribed a PAP Device

  90 Days

• Percent of Participants Who Meet 90 Day Compliance Success Criteria

  90 Days

Study Arms (1)

Arm 1

EXPERIMENTAL

Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)

Device: Verily Sleep Apnea (VSA) Program/App

Interventions

Verily Sleep Apnea (VSA) Program/App DEVICE

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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Verily Life Sciences LLC: lead

Study Sites (1)

Verily Life Sciences LLC

South San Francisco, California, 94080, United States

Location

Related Publications (2)

• Kumar S, Rudie E, Dorsey C, Caswell K, Blase A, Sert Kuniyoshi F, Benjafield AV, Sullivan SS. Pilot study of positive airway pressure usage, patient journey and program engagement for users of a digital obstructive sleep apnea program. Front Digit Health. 2023 Jun 7;5:1043578. doi: 10.3389/fdgth.2023.1043578. eCollection 2023.

  PMID: 37351372 DERIVED

• 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.

  PMID: 34792470 DERIVED

Results Point of Contact

• Title: Gabriel Kowalsky
• Organization: Verily Life Sciences LLC

gabekowalsky@verily.com

9709011616

Study Officials

• Shannon Sullivan, MD

  Verily Life Sciences LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: July 8, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-08

Locations

US (1)