Obstructive Sleep Apnea of AdultNCT04599803

Baseline Sleep Apnea Study #2

A study testing Verily Sleep Apnea (VSA) Program/App in people with Obstructive Sleep Apnea of Adult, run by Verily Life Sciences LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea of Adult
What is being tested?: Verily Sleep Apnea (VSA) Program/App
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 187 participants
Where: 1 siteUnited States
Study dates: 8 Jul 2020to 30 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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+

Show all 11Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Verily Life Sciences LLC
South San Francisco, California, 94080

Other trials in United States

About this study

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
Being tested: Verily Sleep Apnea (VSA) Program/App

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04599803
Study group	Role	What they receive
Arm 1	Experimental	Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST) Receives: Device: Verily Sleep Apnea (VSA) Program/App

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 164 days
Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation
Time from OSA diagnosis to PAP therapy initiation.
Measured: 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.
Measured: 90 Days

Secondary outcomes (4)

Completion Rates Among Individuals Who Had an HST Ordered
Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.
Measured: 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).
Measured: 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
Measured: 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
Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202030 Mar 2021

First posted23 Oct 2020
Study start8 Jul 2020
Primary completion30 Mar 2021
Study completion30 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04599803
Sponsor's protocol ID: 102033
Status last verified: Aug 2022
First submitted: 19 Oct 2020
Last updated: 5 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 37351372
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.
PubMed 34792470

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
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Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
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RecruitingPhase 4
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Not yet recruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 4
A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
Obstructive Sleep Apnea (OSA)

All Obstructive Sleep Apnea of Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Baseline Sleep Apnea Study #2
ClinicalTrials.gov ID: NCT04599803
Acronym / sponsor ID: 102033
Conditions: Obstructive Sleep Apnea of Adult
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Verily Life Sciences LLCIndustry (pharma, biotech, devices)
Study start: 8 Jul 2020 (actual)
Primary completion: 30 Mar 2021 (actual)
Study completion: 30 Mar 2021 (actual)
First posted: 23 Oct 2020 (actual)
Results: Posted 5 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Device: Verily Sleep Apnea (VSA) Program/AppParticipants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Verily Sleep Apnea (VSA) Program/AppThe VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.	Device	Arm 1

Primary outcome

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
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.
Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation
Time frame: 153 Days
Time from OSA diagnosis to PAP therapy initiation.
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.

4 secondary outcomes

Completion Rates Among Individuals Who Had an HST Ordered
Time frame: 161 Days
Completion Rates Among Individuals Prescribed a PAP Device
Time frame: 153 Days
Completion Rates Among Individuals Prescribed a PAP Device
Time frame: 90 Days
Percent of Participants Who Meet 90 Day Compliance Success Criteria
Time frame: 90 Days

Results and safety

Results posted to the registry on 5 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	187	156

Primary outcome: Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription

Time frame: 147 Days. Mean (Standard Deviation). Unit: days

Measure	Arm 1 n = 157
Value	7.4 (2.7)

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

Primary outcome: Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis

Time frame: 164 days. Mean (Standard Deviation). Unit: days

Measure	Arm 1 n = 114
Value	13.9 (9.6)

Population analysed: Participants diagnosed with OSA

Primary outcome: Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation

Time frame: 153 Days. Mean (Standard Deviation). Unit: days

Measure	Arm 1 n = 105
Value	8.1 (9.3)

Population analysed: Participants diagnosed with OSA and received PAP device

Primary outcome: Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved

Time frame: 90 Days. Mean (Standard Deviation). Unit: days

Measure	Arm 1 n = 68
Value	37.5 (14.25)

Population analysed: Participants who reached compliance with their PAP device

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the entire duration of participation (232 Days). Reported Adverse Events were monitored through study completion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	1 of 105 (1%)	14 of 105 (13.3%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37351372Kumar 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.
Derived from this study: PubMed 34792470Kumar 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.

Related trials for Obstructive Sleep Apnea of Adult

Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
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RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
Not yet recruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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RecruitingPhase 4
A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shannon Sullivan, MD principal investigator

Verily Life Sciences LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Verily Sleep Apnea (VSA) Program/App in people with Obstructive Sleep Apnea of Adult, run by Verily Life Sciences LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription (time frame: 147 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04599803, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.