Obstructive Sleep Apnea of Adult
Conditions
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.
Interventions
DEVICEVerily Sleep Apnea (VSA) Program/App
The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.
Sponsors
Verily Life Sciences LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | 164 days | Time from when the participant receives HST prescription to OSA diagnosis. |
| Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rates Among Individuals Prescribed a PAP Device | 153 Days | Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them). |
| Percent of Participants Who Meet 90 Day Compliance Success Criteria | 90 Days | 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 |
| Completion Rates Among Individuals Who Had an HST Ordered | 161 Days | Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Participants must have met all eligibility criteria and logged into the Verily Sleep Apnea (VSA) App in order to be considered enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 26 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Participants Diagnosed With Obstructive Sleep Apnea |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants |
| Age, Continuous | 48 Years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 80 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 27 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United States | 105 Participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 105 |
| other Total, other adverse events | 14 / 105 |
| serious Total, serious adverse events | 1 / 105 |
Outcome results
Primary
Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation
Time from OSA diagnosis to PAP therapy initiation.
Time frame: 153 Days
Population: Participants diagnosed with OSA and received PAP device
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation | 8.1 days | Standard Deviation 9.3 |
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.
Time frame: 90 Days
Population: Participants who reached compliance with their PAP device
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved | 37.5 days | Standard Deviation 14.25 |
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
Time frame: 147 Days
Population: Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription | 7.4 days | Standard Deviation 2.7 |
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.
Time frame: 164 days
Population: Participants diagnosed with OSA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis | 13.9 days | Standard Deviation 9.6 |
Secondary
Completion Rates Among Individuals Prescribed a PAP Device
Percentage of individuals who used the PAP device at least once during the 90 days
Time frame: 90 Days
Population: Participants diagnosed with OSA and received PAP device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Completion Rates Among Individuals Prescribed a PAP Device | 103 Participants |
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).
Time frame: 153 Days
Population: Participants diagnosed with OSA who received a prescription for PAP as part of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Completion Rates Among Individuals Prescribed a PAP Device | 105 Participants |
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.
Time frame: 161 Days
Population: Participants who received a HST
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Completion Rates Among Individuals Who Had an HST Ordered | 153 Participants |
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
Time frame: 90 Days
Population: Participants diagnosed with OSA and received PAP device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Percent of Participants Who Meet 90 Day Compliance Success Criteria | 68 Participants |