Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 6:10 AM
Study NCT ID:
NCT04764734
Status:
UNKNOWN
Last Update Posted:
2022-09-06
First Post:
2021-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Validation Study of the NightOwl Home Sleep Apnea Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, '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 apnea hypopnea index (AHI) estimate, 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. This study will be performed in a sleep lab environment."}, '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'}, 'identificationModule': {'nctId': 'NCT04764734', 'briefTitle': 'A Validation Study of the NightOwl Home Sleep Apnea Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ectosense NV'}, 'officialTitle': 'A Validation Study of the NightOwl Home Sleep Apnea Test', 'orgStudyIdInfo': {'id': 'NightOwl-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PSG and NightOwl', 'description': 'During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with the informed consent form. 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': '33071', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Coral Springs Laboratory', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'United Sleep Diagnostics Hollywood Laboratory', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Lakes Laboratory', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'United Sleep Diagnostics Pembroke Pines Laboratory', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}], 'overallOfficials': [{'name': 'Jagdeep Bijwadia, MD MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SleepMed RX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ectosense NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}