Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-31 @ 1:48 AM
Study NCT ID:
NCT04599803
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2020-10-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Baseline Sleep Apnea Study #2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gabekowalsky@verily.com', 'phone': '9709011616', 'title': 'Gabriel Kowalsky', 'organization': 'Verily Life Sciences LLC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the entire duration of participation (232 Days). Reported Adverse Events were monitored through study completion.', 'description': 'Per Protocol:\n\nAn 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.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Participants diagnosed with Obstructive Sleep Apnea (OSA) and provided a positive airway pressure (PAP) device.\n\nThis 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.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 14, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Skin Sore', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue and sore throat due to COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Stone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough due to COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough and upper respiratory symptoms due to COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever due to COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestion due to COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/ Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry nose/bloody nose due to weather', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization subsequent to apparent syncopal event leading to chest wall injury', 'notes': 'Hospitalization subsequent to apparent syncopal event leading to chest wall injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '147 Days', 'description': 'Time (number of days) from when participant is told they may have OSA to when they receive HST prescription', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}, {'type': 'PRIMARY', 'title': 'Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '9.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '164 days', 'description': 'Time from when the participant receives HST prescription to OSA diagnosis.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants diagnosed with OSA'}, {'type': 'PRIMARY', 'title': 'Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '9.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '153 Days', 'description': 'Time from OSA diagnosis to PAP therapy initiation.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants diagnosed with OSA and received PAP device'}, {'type': 'PRIMARY', 'title': 'Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '14.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 Days', 'description': 'Time (number of days) from therapy initiation to when 90-day compliance threshold is achieved.\n\n90-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.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who reached compliance with their PAP device'}, {'type': 'SECONDARY', 'title': 'Completion Rates Among Individuals Who Had an HST Ordered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'classes': [{'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '161 Days', 'description': 'Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received a HST'}, {'type': 'SECONDARY', 'title': 'Completion Rates Among Individuals Prescribed a PAP Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '153 Days', 'description': 'Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants diagnosed with OSA who received a prescription for PAP as part of the study'}, {'type': 'SECONDARY', 'title': 'Completion Rates Among Individuals Prescribed a PAP Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days', 'description': 'Percentage of individuals who used the PAP device at least once during the 90 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants diagnosed with OSA and received PAP device'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Who Meet 90 Day Compliance Success Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants diagnosed with OSA and received PAP device'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Defined for the purpose of this table to have met eligibility criteria and signed into the Verily Sleep Apnea (VSA) app', 'groupId': 'FG000', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'Participants must have met all eligibility criteria and logged into the Verily Sleep Apnea (VSA) App in order to be considered enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Diagnosed With Obstructive Sleep Apnea', 'description': '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.\n\nVerily Sleep Apnea (VSA) Program/App: The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only participants that were prescribed a PAP device were included evaluable population for analysis.'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants that were prescribed a PAP device were included evaluable population for analysis.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only participants that were prescribed a PAP device were included evaluable population for analysis.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only participants that were prescribed a PAP device were included evaluable population for analysis.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only participants that were prescribed a PAP device were included evaluable population for analysis.\n\nParticipants could select all that apply, so percentages sum to more than 100%.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only participants that were prescribed a PAP device were included evaluable population for analysis.'}], 'populationDescription': 'Participants that were diagnosed with sleep apnea and prescribed a positive airway pressure (PAP) device'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-31', 'size': 698010, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-13T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2020-10-19', 'resultsFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-26', 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription', 'timeFrame': '147 Days', 'description': 'Time (number of days) from when participant is told they may have OSA to when they receive HST prescription'}, {'measure': 'Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis', 'timeFrame': '164 days', 'description': 'Time from when the participant receives HST prescription to OSA diagnosis.'}, {'measure': 'Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation', 'timeFrame': '153 Days', 'description': 'Time from OSA diagnosis to PAP therapy initiation.'}, {'measure': 'Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved', 'timeFrame': '90 Days', 'description': 'Time (number of days) from therapy initiation to when 90-day compliance threshold is achieved.\n\n90-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.'}], 'secondaryOutcomes': [{'measure': 'Completion Rates Among Individuals Who Had an HST Ordered', 'timeFrame': '161 Days', 'description': 'Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.'}, {'measure': 'Completion Rates Among Individuals Prescribed a PAP Device', 'timeFrame': '153 Days', 'description': 'Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them).'}, {'measure': 'Completion Rates Among Individuals Prescribed a PAP Device', 'timeFrame': '90 Days', 'description': 'Percentage of individuals who used the PAP device at least once during the 90 days'}, {'measure': 'Percent of Participants Who Meet 90 Day Compliance Success Criteria', 'timeFrame': '90 Days', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea of Adult']}, 'referencesModule': {'references': [{'pmid': '37351372', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34792470', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 or older\n* Able to speak and read English\n* Legal United States Resident with a Government Issued ID\n* Participating in the Project Baseline Community Study\n* Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form\n* 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+\n* Own a computer with a web camera\n* Consistent access to electricity and wifi for the duration of the study\n* Have a high risk of OSA as determined by screening questionnaire\n* Good candidate for PAP therapy, in the opinion of the managing clinician\n* Without significant limitation in ability to participate in the study, in the opinion of the investigator.\n\nExclusion Criteria:\n\n* 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)\n* 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)\n* Sponsor employees and individuals working on Project Baseline\n* Self reported to be pregnant or planning to become pregnant during the study period\n* Current use of home oxygenation devices, such as supplemental oxygen'}, 'identificationModule': {'nctId': 'NCT04599803', 'briefTitle': 'Baseline Sleep Apnea Study #2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Verily Life Sciences LLC'}, 'officialTitle': 'Baseline Sleep Apnea Study #2', 'orgStudyIdInfo': {'id': '102033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)', 'interventionNames': ['Device: Verily Sleep Apnea (VSA) Program/App']}], 'interventions': [{'name': 'Verily Sleep Apnea (VSA) Program/App', 'type': 'DEVICE', 'description': 'The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Verily Life Sciences LLC', 'geoPoint': {'lat': 37.65466, 'lon': -122.40775}}], 'overallOfficials': [{'name': 'Shannon Sullivan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Verily Life Sciences LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Verily Life Sciences LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}