Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT03188718
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2017-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
WatchPAT Device Validation Study Compared to Polysomnography
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], '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': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalresearchsupportcenter@ucdenver.edu', 'phone': '3037241111', 'title': 'Michelle Sobremonte-King, MD', 'organization': 'University of Colorado Denver'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 10 hours', 'eventGroups': [{'id': 'EG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '63.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '93'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'Peripheral index from the device sensor as measured on the skin, similar to a pulse oximeter. Count of respiratory events that do not meet the criteria for apnea, but that cause a disturbance in sleep.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Desaturation Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '.3', 'upperLimit': '43.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep Staging: Light and Deep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'title': 'Light', 'categories': [{'measurements': [{'value': '180', 'spread': '48.5', 'groupId': 'OG000'}]}]}, {'title': 'Deep', 'categories': [{'measurements': [{'value': '108', 'spread': '35.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 hours', 'description': 'Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'Amount of oxygen present in the subjects blood via pulse oximetry.', 'unitOfMeasure': 'percentage of O2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '104'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'Documentation of the Subjects heart rate.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'title': 'Supine', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '489'}]}]}, {'title': 'Non-supine', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '434'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep Time (Total)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000', 'lowerLimit': '155', 'upperLimit': '515'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'The Total Sleep Duration time in minutes as recorded by the PSG.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep Staging: REM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '276'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Participant noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Device failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).\n\nWatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '2.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The 8 participants who did not complete the study are excluded from the baseline characteristics data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-01', 'size': 259562, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-23T18:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "Blinded to the subject's diagnosis"}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2017-06-01', 'resultsFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-20', 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)', 'timeFrame': 'Up to 10 hours', 'description': 'Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more.'}], 'secondaryOutcomes': [{'measure': 'Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)', 'timeFrame': 'Up to 10 hours', 'description': 'Peripheral index from the device sensor as measured on the skin, similar to a pulse oximeter. Count of respiratory events that do not meet the criteria for apnea, but that cause a disturbance in sleep.'}, {'measure': 'Oxygen Desaturation Index (ODI)', 'timeFrame': 'Up to 10 hours', 'description': 'Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour.'}, {'measure': 'Sleep Staging: Light and Deep', 'timeFrame': 'Up to 10 hours', 'description': 'Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM).'}, {'measure': 'Oxygen Saturation', 'timeFrame': 'Up to 10 hours', 'description': 'Amount of oxygen present in the subjects blood via pulse oximetry.'}, {'measure': 'Heart Rate', 'timeFrame': 'Up to 10 hours', 'description': 'Documentation of the Subjects heart rate.'}, {'measure': 'Body Position', 'timeFrame': 'Up to 10 hours', 'description': 'Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.'}, {'measure': 'Sleep Time (Total)', 'timeFrame': 'Up to 10 hours', 'description': 'The Total Sleep Duration time in minutes as recorded by the PSG.'}, {'measure': 'Sleep Staging: REM', 'timeFrame': 'Up to 10 hours', 'description': 'Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Polysomnogram', 'Sleep Disordered Breathing'], 'conditions': ['Sleep Apnea Syndromes', 'Sleep Disorder', 'Sleep']}, 'descriptionModule': {'briefSummary': 'Validation study of a novel sleep Device compared to a traditional sleep study.', 'detailedDescription': 'This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 5 through 12 years of age.\n2. Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:\n\n * snoring,\n * witnessed apneas,\n * daytime sleepiness, and\n * mouth breathing, etc.\n3. Informed consent obtained.\n\nExclusion Criteria:\n\n1. Medical conditions that can affect the tonometer reading such as:\n\n * peripheral vascular disease,\n * cyanotic heart disease,\n * systemic hypertension, and\n * sickle cell crisis.\n2. Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:\n\n * autism spectrum disorder,\n * Trisomy 21, and\n * neurodevelopmental disorders.\n3. History of neuromuscular malformation\n4. History of current supplemental oxygen use\n5. History of current vasoactive, cardiac or seizure medication use\n6. Inability or unwillingness to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03188718', 'acronym': 'WPAT', 'briefTitle': 'WatchPAT Device Validation Study Compared to Polysomnography', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age', 'orgStudyIdInfo': {'id': '17-0827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'WatchPAT Intervention', 'description': 'Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram).', 'interventionNames': ['Device: WatchPAT Intervention']}], 'interventions': [{'name': 'WatchPAT Intervention', 'type': 'DEVICE', 'description': 'Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.', 'armGroupLabels': ['WatchPAT Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Michelle Sobremonte-King, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Ann Halbower, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'Itamar-Medical, Israel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}