Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-18 @ 10:27 PM
Study NCT ID:
NCT02814227
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2015-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validation of Sleep Apnea Screening Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': 'tarnedt@med.umich.edu', 'phone': '734-615-8666', 'title': 'J. Todd Arnedt, PhD', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Zansors® Sleep Screening Device', 'description': 'Zansors device compared to overnight polysomnography\n\nZansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zansors® Sleep Screening Device', 'description': 'Zansors device compared to overnight polysomnography\n\nZansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': "Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals", 'unitOfMeasure': 'percentage of true negatives', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zansors® Sleep Screening Device', 'description': 'Zansors device compared to overnight polysomnography\n\nZansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': "Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals", 'unitOfMeasure': 'percentage of true positives', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Predictive Value (PPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zansors® Sleep Screening Device', 'description': 'Zansors device compared to overnight polysomnography\n\nZansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography'}], 'classes': [{'categories': [{'measurements': [{'value': '0.692', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': "PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals", 'unitOfMeasure': 'positive predictive value', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Negative Predictive Value (NPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zansors® Sleep Screening Device', 'description': 'Zansors device compared to overnight polysomnography\n\nZansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours', 'description': "NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals", 'unitOfMeasure': 'negative predictive value', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zansors® Sleep Screening Device', 'description': 'Zansors device compared to overnight polysomnography\n\nZansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Zansors® Sleep Screening Device', 'description': 'Zansors device compared to overnight polysomnography\n\nZansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2015-10-25', 'resultsFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-27', 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specificity', 'timeFrame': '8 hours', 'description': "Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals"}], 'secondaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': '8 hours', 'description': "Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals"}, {'measure': 'Positive Predictive Value (PPV)', 'timeFrame': '8 hours', 'description': "PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals"}, {'measure': 'Negative Predictive Value (NPV)', 'timeFrame': '8 hours', 'description': "NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea screening device'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': "Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an estimated 18-40 million adults and 0.7-3% of all children in the US. The marketplace currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. The specific goal of this project is to compare the Zansors® micro sleep sensor screening device against gold-standard polysomnography to establish the device's preliminary validity to screen for OSA accurately.", 'detailedDescription': "Obstructive Sleep Apnea (OSA) results in tiredness, depression and fatigue, and has several associated common comorbidities. It is believed that over 80% of OSA remains undiagnosed. Poorer and disadvantaged communities are at higher risk for sleep disorders, including OSA, even after accounting for other risk factors. The gold-standard method for diagnosing OSA is in-laboratory polysomnography; however, this procedure is generally available only to patients with health insurance due to its high cost. As a result, communities at particularly high risk for OSA are less likely to have this serious sleep disorder appropriately diagnosed and treated.\n\nAn affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. Zansors® has developed a bioengineered, semiconductor prototype that measures breathing and movement during sleep. It is a 1.5 x 2.5 x 0.2 inch wireless package using four key technologies:\n\n1. an adjustable microphone;\n2. a 3-axis accelerometer;\n3. embedded algorithms to measure sleep events; and\n4. acrylic adhesive.\n\nThe product will be designed as an FDA-approved over-the-counter device that the patient can wear during sleep and wake up with a color score of red, yellow, or green depending on their sleep apnea status. The features of this product include that it is home-based; easy to use; non-invasive; wireless; disposable; low cost ($20-50); and presents easily understandable test results. However, such a device must first be validated against gold-standard polysomnography.\n\nThe specific goal of this project is to compare the Zansors® micro sleep sensor screening device against gold-standard polysomnography to establish the device's preliminary validity to screen for OSA accurately."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be over 18 and referred by medical staff for an overnight assessment for suspected sleep apnea\n\nExclusion Criteria:\n\n* Pregnancy\n* Heart disease including congestive heart failure or a pacemaker\n* Breathing disorder (emphysema or chronic obstructive breathing disorder)\n* Neurological disorder such as Parkinson's Disease\n* Restless leg syndrome or Periodic limb movement\n* Allergies to metal\n* Pre-existing skin conditions where sensor would be attached"}, 'identificationModule': {'nctId': 'NCT02814227', 'briefTitle': 'Validation of Sleep Apnea Screening Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Wireless Sensor Patch for Reducing Barriers to In-home Sleep Apnea Screening', 'orgStudyIdInfo': {'id': 'R41MD008845-01', 'link': 'https://reporter.nih.gov/quickSearch/R41MD008845-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zansors® sleep screening device', 'description': 'Zansors device compared to overnight polysomnography', 'interventionNames': ['Device: Zansors® sleep screening device']}], 'interventions': [{'name': 'Zansors® sleep screening device', 'type': 'DEVICE', 'description': 'Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography', 'armGroupLabels': ['Zansors® sleep screening device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'J. Todd Arnedt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zansors', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'J. Todd Arnedt', 'investigatorAffiliation': 'University of Michigan'}}}}