Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02677168
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
cNEP for the 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'}, {'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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II', 'timeFrame': 'three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I', 'description': 'A response (either initial or sustained) is defined as an AHI that is \\< 50% of the qualifying PSG (polysomnography) that is also \\< 15/hr'}, {'measure': 'occurrence of adverse events', 'timeFrame': 'three weeks', 'description': 'Adverse events that occur during the three weeks of cNEP home use.'}], 'secondaryOutcomes': [{'measure': '"Initial Response" of AHI at PSG I', 'timeFrame': 'up to 12 months after the qualifying PSG', 'description': 'An AHI (apnea hypopnea index) that is \\<50% of that of the qualifying PSG, and \\<15/hr at PSG I, with cNEP in place.'}, {'measure': 'Comparison of AHI at PSG I and PSG II', 'timeFrame': 'three weeks', 'description': 'The AHI determined at PSG II will be compared with that of PSG I'}, {'measure': 'time of SpO2 (oxygen saturation) < 90%', 'timeFrame': 'during each of the overnight PSGs', 'description': 'the number of minutes during the overnight PSG when SpO2 is \\< 90% with cNEP in place'}, {'measure': 'hours of home use of cNEP per night', 'timeFrame': 'three weeks after initiation of home cNEP', 'description': 'the number of hours of each night at home that the subject uses cNEP'}, {'measure': 'Three CGI (clinical global impression) subjective measures', 'timeFrame': 'three weeks after the initiation of home cNEP', 'description': "Seven-item Likert CGI scales of three subjective measures: 1) subject's view of cNEP vs CPAP, 2) overall satisfaction with cNEP, 3) bed partner's feelings about cNEP."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'sleep apnea', 'OSA', 'cNEP', 'continuous negative external pressure'], 'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG")\n* on that PSG, AHI must be 10 - 50/hr and \\>80% of the apneas and hypopneas must be obstructive\n* no significant changes in health, medications, or lifestyle since the qualifying PSG\n\nKey Exclusion Criteria:\n\n* previous major surgery, injury or radiation to the neck\n* beard or excessive hair on the area of the neck where the collar will be applied\n* carotid artery disease\n* serious medical conditions\n* pregnancy\n* use of home oxygen\n* silicone allergy\n* sleep disturbance other than obstructive sleep apnea'}, 'identificationModule': {'nctId': 'NCT02677168', 'acronym': 'cNEP', 'briefTitle': 'cNEP for the Treatment of Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sommetrics, Inc.'}, 'officialTitle': 'Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)', 'orgStudyIdInfo': {'id': 'SOM-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cNEP', 'description': 'Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks', 'interventionNames': ['Device: cNEP']}], 'interventions': [{'name': 'cNEP', 'type': 'DEVICE', 'description': 'continuous negative external pressure', 'armGroupLabels': ['cNEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4P 1P2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sleep Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Adam Blackman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Sleep Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sommetrics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}