Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01809418
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2013-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
keePAP Device for Treatment of 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-02', 'studyFirstSubmitDate': '2013-03-10', 'studyFirstSubmitQcDate': '2013-03-10', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AHI/RDI and oxygen saturation during sleep', 'timeFrame': 'one night', 'description': 'Efficacy of the keePAP system in reducing the number of obstructive breathing events during sleep as indexed by the AHI and measures of oxygen saturation during sleep.'}], 'secondaryOutcomes': [{'measure': 'Patient comfort', 'timeFrame': 'one night', 'description': 'Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '10450601', 'type': 'BACKGROUND', 'citation': 'Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during sleep.', 'detailedDescription': 'Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.\n\nThe aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the AHI/RDI and measures of oxygen saturation during sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over between 18 and 80 years old;\n* AHI/RDI \\> 5\n\nExclusion Criteria:\n\n* Uncontrolled or serious illness (angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure),\n* Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment;\n* History of severe nasal allergies or sinusitis or difficulty breathing through the nose;\n* Persistent blockage of one or both nostrils;\n* Any previous operation or trauma to the nose;\n* Any nasal, facial or head abnormalities that would not allow adequate placement of the device.\n* Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure.\n* Female subjects of childbearing age were excluded if they were pregnant or intending to become pregnant.'}, 'identificationModule': {'nctId': 'NCT01809418', 'briefTitle': 'keePAP Device for Treatment of Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'keepMED Ltd.'}, 'officialTitle': 'Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events', 'orgStudyIdInfo': {'id': 'keePAP-1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'keePAP', 'interventionNames': ['Device: keePAP']}], 'interventions': [{'name': 'keePAP', 'type': 'DEVICE', 'armGroupLabels': ['keePAP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Asher Tal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'keepMED Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}