Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
Study NCT ID:
NCT04191668
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2019-11-19
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frederik.massie@ectosense.com', 'phone': '+1 786 305 8547', 'title': 'Frederik Massie', 'organization': 'Ectosense'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Through study completion (during the participant's single-night sleep study)", 'eventGroups': [{'id': 'EG000', 'title': 'PSG and NightOwl', 'description': 'Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.\n\nNightOwl: The NightOwl is a finger-mounted home sleep apnea testing device', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pearson Correlation Between the AHI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG and NightOwl', 'description': 'Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.\n\nNightOwl: The NightOwl is a finger-mounted home sleep apnea testing device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.909', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 1 month.', 'description': 'The evaluation of the Pearson correlation between the apnea-hypopnea index (AHI) estimate obtained from the NightOwl and the AHI determined from the polysomnography (PSG); The AHI is defined as the number of apnea or hypopnea divided by the (estimated) total sleep time expressed in hours.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.'}, {'type': 'PRIMARY', 'title': 'Pearson Correlation Between the TST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG and NightOwl', 'description': 'Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.\n\nNightOwl: The NightOwl is a finger-mounted home sleep apnea testing device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.610', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 1 month.', 'description': 'The evaluation of the Pearson correlation between the total sleep time (TST) estimate obtained from the NightOwl and the TST determined from the PSG;', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.'}, {'type': 'PRIMARY', 'title': 'The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG and NightOwl', 'description': 'Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.\n\nNightOwl: The NightOwl is a finger-mounted home sleep apnea testing device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.685', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 1 month.', 'description': 'The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.', 'unitOfMeasure': 'Ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PSG and NightOwl', 'description': 'Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.\n\nNightOwl: The NightOwl is a finger-mounted home sleep apnea testing device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PSG and NightOwl', 'description': 'Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.\n\nNightOwl: The NightOwl is a finger-mounted home sleep apnea testing device'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59', 'spread': '15.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For one participant, gender data could not be retrieved.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Black', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32.6', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Only participants for which technically adequate polysomnography and home sleep apnea test data was acquired were retained for Baseline Analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-05', 'size': 673359, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-30T14:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Sleep technician which analyses the PSG data will be blinded from any prior PSG analysis and the NightOwl analysis'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2019-11-19', 'resultsFirstSubmitDate': '2021-01-30', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-18', 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pearson Correlation Between the AHI', 'timeFrame': 'Through study completion, an average of 1 month.', 'description': 'The evaluation of the Pearson correlation between the apnea-hypopnea index (AHI) estimate obtained from the NightOwl and the AHI determined from the polysomnography (PSG); The AHI is defined as the number of apnea or hypopnea divided by the (estimated) total sleep time expressed in hours.'}, {'measure': 'Pearson Correlation Between the TST', 'timeFrame': 'Through study completion, an average of 1 month.', 'description': 'The evaluation of the Pearson correlation between the total sleep time (TST) estimate obtained from the NightOwl and the TST determined from the PSG;'}, {'measure': 'The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization', 'timeFrame': 'Through study completion, an average of 1 month.', 'description': 'The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '39748512', 'type': 'DERIVED', 'citation': 'Massie F, Vits S, Verbraecken J, Bergmann J. Context-aware analysis enhances autoscoring accuracy of home sleep apnea testing. J Clin Sleep Med. 2025 May 1;21(5):789-804. doi: 10.5664/jcsm.11534.'}, {'pmid': '35554589', 'type': 'DERIVED', 'citation': 'Van Pee B, Massie F, Vits S, Dreesen P, Klerkx S, Bijwadia J, Verbraecken J, Bergmann J. A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry. Sleep. 2022 May 12;45(5):zsac028. doi: 10.1093/sleep/zsac028. Epub 2022 Feb 2.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the respiratory event index (REI), defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.", 'detailedDescription': "The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, The investigators will compare the respiratory event index (REI), defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the AHI obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.\n\nAs of March 2017, the new clinical practice guideline for diagnostic testing for adult sleep apnea of the American Academy of Sleep Medicine (AASM) for the first time formulates a strong recommendation that both polysomnography (PSG) and home sleep apnea testing (HSAT) are appropriate diagnostic testing options for uncomplicated adult patients who are at increased risk of moderate to severe sleep apnea.\n\nCollop et al. performed a comprehensive analysis of the evidence for HSAT devices to diagnose obstructive sleep apnea (OSA) in out-of-center settings. The authors concluded that testing devices that analyze changes in peripheral arterial tone (PAT) in combination with actigraphy and blood oxygen saturation (SpO2) are adequate to diagnose OSA in patient populations with a high pre-test probability.\n\nIn this study, the investigators wish to assess the performance of a system for the diagnosis of OSA that measures and analyzes the abovementioned parameters, called NightOwl. The system consists of a small sensor device which is placed on the fingertip and a cloud-based analytics platform.\n\nIt is designed to be self-applied and initiated by the patient by attaching the sensor to the fingertip by means of an adhesive patch."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with an indication for an in-lab polysomnography\n\nExclusion Criteria:\n\n* Intellectually disabled people\n* People younger than 13 years of age.'}, 'identificationModule': {'nctId': 'NCT04191668', 'briefTitle': 'A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ectosense NV'}, 'officialTitle': 'A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test', 'orgStudyIdInfo': {'id': 'NightOwl-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PSG and NightOwl', 'description': 'Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.', 'interventionNames': ['Device: NightOwl']}], 'interventions': [{'name': 'NightOwl', 'type': 'DEVICE', 'description': 'The NightOwl is a finger-mounted home sleep apnea testing device', 'armGroupLabels': ['PSG and NightOwl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Lakes Laboratory', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Plantation Laboratory East', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Plantation Laboratory West', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}], 'overallOfficials': [{'name': 'Frederik Massie, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ectosense NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ectosense NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}