search
Back to results

Baseline Sleep Apnea Study #2

Primary Purpose

Obstructive Sleep Apnea of Adult

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verily Sleep Apnea (VSA) Program/App
Sponsored by
Verily Life Sciences LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Verily Life Sciences LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.
Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation
Time from OSA diagnosis to PAP therapy initiation.
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.

Secondary Outcome Measures

Completion Rates Among Individuals Who Had an HST Ordered
Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.
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).
Completion Rates Among Individuals Prescribed a PAP Device
Percentage of individuals who used the PAP device at least once during the 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

Full Information

First Posted
October 19, 2020
Last Updated
September 26, 2022
Sponsor
Verily Life Sciences LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT04599803
Brief Title
Baseline Sleep Apnea Study #2
Official Title
Baseline Sleep Apnea Study #2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verily Life Sciences LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Intervention Type
Device
Intervention Name(s)
Verily Sleep Apnea (VSA) Program/App
Intervention Description
The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.
Primary Outcome Measure Information:
Title
Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription
Description
Time (number of days) from when participant is told they may have OSA to when they receive HST prescription
Time Frame
147 Days
Title
Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis
Description
Time from when the participant receives HST prescription to OSA diagnosis.
Time Frame
164 days
Title
Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation
Description
Time from OSA diagnosis to PAP therapy initiation.
Time Frame
153 Days
Title
Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved
Description
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.
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Completion Rates Among Individuals Who Had an HST Ordered
Description
Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.
Time Frame
161 Days
Title
Completion Rates Among Individuals Prescribed a PAP Device
Description
Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them).
Time Frame
153 Days
Title
Completion Rates Among Individuals Prescribed a PAP Device
Description
Percentage of individuals who used the PAP device at least once during the 90 days
Time Frame
90 Days
Title
Percent of Participants Who Meet 90 Day Compliance Success Criteria
Description
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
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Sullivan, MD
Organizational Affiliation
Verily Life Sciences LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Verily Life Sciences LLC
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34792470
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.
Results Reference
derived

Learn more about this trial

Baseline Sleep Apnea Study #2

We'll reach out to this number within 24 hrs