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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verily Sleep Apnea (VSA) Program/App | Device | The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Sullivan, MD | Verily Life Sciences LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Verily Life Sciences LLC | South San Francisco | California | 94080 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37351372 | Derived | 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. | |
| 34792470 |
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Participants must have met all eligibility criteria and logged into the Verily Sleep Apnea (VSA) App in order to be considered enrolled.
This study was conducted entirely virtually using the Baseline Platform, a comprehensive remote clinical studies platform for recruitment, consenting, screening, enrollment, data collection, and study monitoring.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants that were diagnosed with sleep apnea and prescribed a positive airway pressure (PAP) device
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Diagnosed With Obstructive Sleep Apnea | This will be a single arm study of participants that are diagnosed with Obstructive Sleep Apnea (OSA) during the study. Upon confirmation of OSA and prescription of positive airway pressure (PAP) therapy, the participant will begin using the Verily Sleep Apnea (VSA) app to supplement PAP treatment. Verily Sleep Apnea (VSA) Program/App: The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Only participants that were prescribed a PAP device were included evaluable population for analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST) | Posted | Mean | Standard Deviation | days | 147 Days |
|
|
Adverse events were collected during the entire duration of participation (232 Days). Reported Adverse Events were monitored through study completion.
Per Protocol:
An Adverse Event (AE) is defined as any untoward medical occurrence, unintended disease or injury in subjects, users or other persons, that is considered a change from baseline or pre-study status, whether or not related to the investigational medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Participants diagnosed with Obstructive Sleep Apnea (OSA) and provided a positive airway pressure (PAP) device. This was a single arm study of participants that are diagnosed with Obstructive Sleep Apnea (OSA) during the study. Upon confirmation of OSA and prescription of positive airway pressure (PAP) therapy, the participant began using the Verily Sleep Apnea (VSA) app to supplement PAP treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization subsequent to apparent syncopal event leading to chest wall injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Sore | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Kowalsky | Verily Life Sciences LLC | 9709011616 | gabekowalsky@verily.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2020 | Jul 13, 2022 | Prot_SAP_001.pdf |
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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 |
| 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. |
| Count of Participants |
| Participants |
|
| Age, Continuous | Only participants that were prescribed a PAP device were included evaluable population for analysis. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Only participants that were prescribed a PAP device were included evaluable population for analysis. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Only participants that were prescribed a PAP device were included evaluable population for analysis. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only participants that were prescribed a PAP device were included evaluable population for analysis. Participants could select all that apply, so percentages sum to more than 100%. | Count of Participants | Participants |
|
| Region of Enrollment | Only participants that were prescribed a PAP device were included evaluable population for analysis. | Count of Participants | Participants |
|
|
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| Primary | 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. | Participants diagnosed with OSA | Posted | Mean | Standard Deviation | days | 164 days |
|
|
|
| Primary | Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation | Time from OSA diagnosis to PAP therapy initiation. | Participants diagnosed with OSA and received PAP device | Posted | Mean | Standard Deviation | days | 153 Days |
|
|
|
| Primary | 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. | Participants who reached compliance with their PAP device | Posted | Mean | Standard Deviation | days | 90 Days |
|
|
|
| Secondary | Completion Rates Among Individuals Who Had an HST Ordered | Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results. | Participants who received a HST | Posted | Count of Participants | Participants | 161 Days |
|
|
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| Secondary | 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). | Participants diagnosed with OSA who received a prescription for PAP as part of the study | Posted | Count of Participants | Participants | 153 Days |
|
|
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| Secondary | Completion Rates Among Individuals Prescribed a PAP Device | Percentage of individuals who used the PAP device at least once during the 90 days | Participants diagnosed with OSA and received PAP device | Posted | Count of Participants | Participants | 90 Days |
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|
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| Secondary | 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 | Participants diagnosed with OSA and received PAP device | Posted | Count of Participants | Participants | 90 Days |
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| 0 |
| 105 |
| 1 |
| 105 |
| 14 |
| 105 |
Hospitalization subsequent to apparent syncopal event leading to chest wall injury
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| Tooth Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
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| Fatigue and sore throat due to COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Sinus Infection | Infections and infestations | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Kidney Stone Pain | Renal and urinary disorders | Non-systematic Assessment |
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| Cough due to COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Respiratory illness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cough and upper respiratory symptoms due to COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Fever due to COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Congestion due to COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Nausea/ Diarrhea | General disorders | Non-systematic Assessment |
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| Dry nose/bloody nose due to weather | General disorders | Non-systematic Assessment |
|
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