Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-11 @ 1:06 PM
Study NCT ID:
NCT03823105
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)', 'timeFrame': '1 night', 'description': 'Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography'}, {'measure': 'The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset', 'timeFrame': '1 night', 'description': 'Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep apnea', 'Hypersomnia', 'Parasomnia'], 'conditions': ['Sleep-Wake Disorders', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.', 'detailedDescription': 'The objective of this study is to evaluate and optimize a method of detecting sleep and sleep stages based on a new algorithm combining actigraphy and heart rate variability (measured by optical analysis of the pulse wave) to determine sleep architecture (segmented into three phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients with sleep wake disorders\n\nInclusion Criteria:\n\n* 18 ≤ Age ≤ 80 years\n* Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)\n* Written informed consent\n\nExclusion Criteria:\n\n* Skin condition with eczema or damaged skin\n* Ischemia (cutaneous)\n* Allergy against nickel\n* Allergy against silicone\n* Current treatment with vasoactive drugs (e.g. beta-blockers, calcium channel antagonists, nitroglycerin, etc.) and/or antidepressive drugs (e.g. serotonin reuptake inhibitors, etc.).\n* Known infection with multiresistant bacteria\n* Implanted devices (e.g. pacemaker, pumps)\n* Rhythmogenic heart disease (e.g. resting heart rate \\> 120/min)\n* Severe or untreated arterial hypertension (blood pressure \\> 140mmHg systolic, \\>90mmHg diastolic)\n* Hypotension (blood pressure \\< 90mmHg systolic, \\< 60 mmHg diastolic)\n* Current alcohol or drug abuse, alcohol consumption the same day as the study\n* Consumption of coffee 7h before\n* Dark skin pigmentation\n* Severe metabolic disease (e.g. diabetes)\n* Pregnancy or lactation\n* Physical handicap effecting the two arms\n* Wound in the wrist region\n* Too large or too small wrist\n\nHealthy subjects\n\nInclusion criteria:\n\n* 18 ≤ Age ≤ 80 years\n* Written informed consent\n\nExclusion criteria:\n\n* Skin condition with eczema or damaged skin\n* Ischemia (cutaneous)\n* Allergy against nickel\n* Allergy against silicone\n* Any Medication (except birth control pill)\n* Known infection with multiresistant bacteria\n* Implanted devices (e.g. pacemaker, pumps)\n* Rhythmogenic heart disease (e.g. resting heart rate \\> 120/min)\n* Severe or untreated arterial hypertension (blood pressure \\> 140mmHg systolic, \\>90mmHg diastolic)\n* Hypotension (blood pressure \\< 90mmHg systolic, \\< 60 mmHg diastolic)\n* Current alcohol or drug abuse, alcohol consumption the same day as the study\n* Consumption of coffee 7h before\n* Implanted devices (e.g. pacemaker, pumps)\n* Known sleep-wake disorders\n* Dark skin pigmentation\n* Severe metabolic disease (e.g. diabetes)\n* Pregnancy or lactation\n* Physical handicap effecting the two arms\n* Wound in the wrist region\n* Too large or too small wrist'}, 'identificationModule': {'nctId': 'NCT03823105', 'briefTitle': 'Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study', 'orgStudyIdInfo': {'id': '2018-00917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nocturnal Recording', 'description': 'Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography', 'interventionNames': ['Device: OHR Tracker and PulseWatch']}], 'interventions': [{'name': 'OHR Tracker and PulseWatch', 'type': 'DEVICE', 'description': 'Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data', 'armGroupLabels': ['Nocturnal Recording']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Bern (Inselspital), Department of Pulmonary Medicine', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Sebastian R. Ott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Berne, Department of Pulmonary Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bern', 'class': 'OTHER'}, {'name': "CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement", 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}