Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 1:02 PM
Study NCT ID:
NCT05049135
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Sensor-less Sleep Monitor (Somnofy®) in Diagnosis and Follow-up in Obstructive Sleep Apnea.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea/hypopnea index', 'timeFrame': '72 hours', 'description': 'Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep'}], 'secondaryOutcomes': [{'measure': 'Sleep score', 'timeFrame': '12 weeks', 'description': 'Objective (AI-based) score of sleep quality from raw data from sleep monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep monitor'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': "To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.", 'detailedDescription': 'A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patents with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy, and their partners', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea\n* able to sign an informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Serious disease which could affect ability to complete the study\n* Complicated sleep disorders'}, 'identificationModule': {'nctId': 'NCT05049135', 'briefTitle': 'Feasibility of a Sensor-less Sleep Monitor (Somnofy®) in Diagnosis and Follow-up in Obstructive Sleep Apnea.', 'organization': {'class': 'OTHER', 'fullName': 'Helse Nord-Trøndelag HF'}, 'officialTitle': 'Long Distance Diagnostics of Sleep Apnea With Objective Sleep Data From a Sensor-less Monitor - a Feasibility Study', 'orgStudyIdInfo': {'id': '200405'}, 'secondaryIdInfos': [{'id': 'CIV-NO-21-08-037486', 'type': 'OTHER', 'domain': 'Eudamed'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleep apnea group', 'description': 'Patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy', 'interventionNames': ['Device: Somnofy® sleep monitor']}, {'label': 'Control group', 'description': 'partners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy', 'interventionNames': ['Device: Somnofy® sleep monitor']}], 'interventions': [{'name': 'Somnofy® sleep monitor', 'type': 'DEVICE', 'otherNames': ['Respiratory polygraphy (NOXT3, ResMed AS)'], 'description': 'Registration of sleep score and apneas with radar sensor technology at time of primary investigation and 12 weeks after treatment initiation with continuous positive airway pressure (CPAP)', 'armGroupLabels': ['Control group', 'Sleep apnea group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Levanger', 'country': 'Norway', 'facility': 'Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}], 'overallOfficials': [{'name': 'Øystein Risa, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging'}, {'name': 'Carl Platou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'North Trøndelag Hospital Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'VitalThings', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}