Baseline Sleep Apnea Study #2

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

Baseline Sleep Apnea Study #2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599803
• Other study ID #: 102033
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: August 2022
• Source: Verily Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Verily Sleep Apnea (VSA) Program/App
The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.

Locations

Country	Name	City	State
United States	Verily Life Sciences LLC	South San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Verily Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	147 Days
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.	164 days
Primary	Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation	Time from OSA diagnosis to PAP therapy initiation.	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.	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.	161 Days
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).	153 Days
Secondary	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
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	90 Days