Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-03-14 @ 8:22 AM
Study NCT ID:
NCT03635918
Status:
UNKNOWN
Last Update Posted:
2018-08-17
First Post:
2018-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extensive Prospective 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2018-08-14', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-Hypopnea Index (AHI)', 'timeFrame': "For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software", 'description': 'Comparison of the AHI derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.'}], 'secondaryOutcomes': [{'measure': 'Sleep-wake discrimination', 'timeFrame': "For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software", 'description': 'Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.', 'detailedDescription': 'The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a finger or forehead mounted sensor and an automated analytics software. The sensor measures double-wavelength photo-plethysmography and accelerometry. The analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. For each patient in the cohort, the AHI derived by the NightOwl will be compared to that of the Type I sleep monitor (in-lab PSG), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. On a randomly selected subset of patients, a benchmark HSAT will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for a sleep study\n\nExclusion Criteria:\n\n* Mentally disabled people'}, 'identificationModule': {'nctId': 'NCT03635918', 'briefTitle': 'Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ectosense NV'}, 'officialTitle': 'Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test', 'orgStudyIdInfo': {'id': '17/034-11/06/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'NightOwl HSAT', 'description': 'Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a benchmark HSAT monitor.', 'interventionNames': ['Device: NightOwl HSAT']}], 'interventions': [{'name': 'NightOwl HSAT', 'type': 'DEVICE', 'description': 'Patient wears the NightOwl sensor device', 'armGroupLabels': ['NightOwl HSAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Inge Thijs, PhD', 'role': 'CONTACT', 'email': 'Inge.Thijs@zol.be', 'phone': '089 32 15 55', 'phoneExt': '+32'}], 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'centralContacts': [{'name': 'Frederik Massie, ir.', 'role': 'CONTACT', 'email': 'frederik.massie@ectosense.com', 'phone': '474942710', 'phoneExt': '+32'}], 'overallOfficials': [{'name': 'Frederik Massie, ir.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ectosense NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ectosense NV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}