Trial Outcomes & Findings for Baseline Sleep Apnea Study #2 (NCT NCT04599803)

NCT ID: NCT04599803

Last Updated: 2022-10-05

Results Overview

Time (number of days) from when participant is told they may have OSA to when they receive HST prescription

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 187 participants
• Primary outcome timeframe: 147 Days
• Results posted on: 2022-10-05

Participant Flow

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.

Participants must have met all eligibility criteria and logged into the Verily Sleep Apnea (VSA) App in order to be considered enrolled.

Participant milestones

Measure	Arm 1 Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Overall Study STARTED	187
Overall Study COMPLETED	156
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Measure	Arm 1 Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Overall Study Withdrawal by Subject	5
Overall Study Lost to Follow-up	26

Baseline Characteristics

Only participants that were prescribed a PAP device were included evaluable population for analysis.

Baseline characteristics by cohort

Measure	Participants Diagnosed With Obstructive Sleep Apnea n=105 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Age, Categorical Between 18 and 65 years	96 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Age, Categorical >=65 years	9 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Age, Continuous	48 Years STANDARD_DEVIATION 10.3 • n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Sex: Female, Male Female	61 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Sex: Female, Male Male	44 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Ethnicity (NIH/OMB) Unknown or Not Reported	80 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants • 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%.
Race (NIH/OMB) Asian	1 Participants n=5 Participants • 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%.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • 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%.
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants • 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%.
Race (NIH/OMB) White	73 Participants n=5 Participants • 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%.
Race (NIH/OMB) More than one race	27 Participants n=5 Participants • 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%.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants • 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%.
Region of Enrollment United States	105 Participants n=5 Participants • Only participants that were prescribed a PAP device were included evaluable population for analysis.

PRIMARY outcome

Timeframe: 147 Days

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

Time (number of days) from when participant is told they may have OSA to when they receive HST prescription

Outcome measures

Measure	Arm 1 n=157 Participants Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
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 outcome

Timeframe: 164 days

Population: Participants diagnosed with OSA

Time from when the participant receives HST prescription to OSA diagnosis.

Outcome measures

Measure	Arm 1 n=114 Participants Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis	13.9 days Standard Deviation 9.6

PRIMARY outcome

Timeframe: 153 Days

Population: Participants diagnosed with OSA and received PAP device

Time from OSA diagnosis to PAP therapy initiation.

Outcome measures

Measure	Arm 1 n=105 Participants Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation	8.1 days Standard Deviation 9.3

PRIMARY outcome

Timeframe: 90 Days

Population: Participants who reached compliance with their PAP device

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.

Outcome measures

Measure	Arm 1 n=68 Participants Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved	37.5 days Standard Deviation 14.25

SECONDARY outcome

Timeframe: 161 Days

Population: Participants who received a HST

Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.

Outcome measures

Measure	Arm 1 n=157 Participants Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Completion Rates Among Individuals Who Had an HST Ordered	153 Participants

SECONDARY outcome

Timeframe: 153 Days

Population: Participants diagnosed with OSA who received a prescription for PAP as part of the study

Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them).

Outcome measures

Measure	Arm 1 n=105 Participants Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Completion Rates Among Individuals Prescribed a PAP Device	105 Participants

SECONDARY outcome

Timeframe: 90 Days

Population: Participants diagnosed with OSA and received PAP device

Percentage of individuals who used the PAP device at least once during the 90 days

Outcome measures

Measure	Arm 1 n=105 Participants Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Completion Rates Among Individuals Prescribed a PAP Device	103 Participants

SECONDARY outcome

Timeframe: 90 Days

Population: Participants diagnosed with OSA and received PAP device

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

Outcome measures

Measure	Arm 1 n=105 Participants Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)
Percent of Participants Who Meet 90 Day Compliance Success Criteria	68 Participants

Adverse Events

Arm 1

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure

Arm 1 n=105 participants at risk 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.

Injury, poisoning and procedural complications Hospitalization subsequent to apparent syncopal event leading to chest wall injury

0.95% 1/105 • Number of events 1 • 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.

Other adverse events

Measure	Arm 1 n=105 participants at risk 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.
Skin and subcutaneous tissue disorders Skin Sore	0.95% 1/105 • Number of events 1 • 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.
Injury, poisoning and procedural complications Tooth Pain	0.95% 1/105 • Number of events 1 • 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.
Renal and urinary disorders Urinary Tract Infection	0.95% 1/105 • Number of events 1 • 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.
Infections and infestations Fatigue and sore throat due to COVID-19	0.95% 1/105 • Number of events 1 • 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.
Infections and infestations Sinus Infection	0.95% 1/105 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.95% 1/105 • Number of events 1 • 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.
Renal and urinary disorders Kidney Stone Pain	0.95% 1/105 • Number of events 1 • 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.
Infections and infestations Cough due to COVID-19	0.95% 1/105 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory illness	0.95% 1/105 • Number of events 1 • 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.
Infections and infestations Cough and upper respiratory symptoms due to COVID-19	0.95% 1/105 • Number of events 1 • 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.
Infections and infestations Fever due to COVID-19	0.95% 1/105 • Number of events 1 • 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.
Infections and infestations Congestion due to COVID-19	0.95% 1/105 • Number of events 1 • 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.
General disorders Nausea/ Diarrhea	0.95% 1/105 • Number of events 1 • 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.
General disorders Dry nose/bloody nose due to weather	0.95% 1/105 • Number of events 1 • 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.

Additional Information

Gabriel Kowalsky

Verily Life Sciences LLC

Phone: 9709011616

Email: gabekowalsky@verily.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place