Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT03375905
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2017-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of cNEP in Ethnic Japanese With 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': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2017-12-07', 'studyFirstSubmitQcDate': '2017-12-12', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of sustained responders', 'timeFrame': 'two weeks after initiation of treatment', 'description': 'reduction of AHI of \\>50% and to \\<15/hr from qualifying PSG'}], 'secondaryOutcomes': [{'measure': 'proportion of initial responders', 'timeFrame': 'at PSG 1, one day', 'description': 'reduction of AHI of \\>50% and to \\<15/hr from qualifying PSG'}, {'measure': 'AHI comparison with qualifying PSG', 'timeFrame': 'one day, on three separate study occasions', 'description': 'apnea-hypopnea index'}, {'measure': 'ODI comparison with qualifying PSG', 'timeFrame': 'one day, on three separate study occasions', 'description': 'oxygen desaturation index'}, {'measure': 'SpO2 <90% comparison with qualifying PSG', 'timeFrame': 'one day, on three separate study occasions', 'description': 'oxygen desaturation index \\<90%'}, {'measure': 'CGI of sleep', 'timeFrame': 'three months, and two weeks, respectively', 'description': 'clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment'}, {'measure': 'CGI of satisfaction with the cNEP device', 'timeFrame': 'after two weeks of treatment', 'description': 'clinical global impressions of the cNEP device'}, {'measure': 'Treatment-emergent adverse events', 'timeFrame': 'two weeks', 'description': 'tabulation of treatment-emergent adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ethnic Japanese'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both parents ethnically Japanese, or one parent Japanese and the other east-Asian\n* PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and \\<80% of apneas and hypopneas are obstructive\n* cNEP collar fits and is well-tolerated\n\nKey exclusion Criteria:\n\n* BMI \\>34\n* abnormalities in neck structure\n* sleep disturbance other than obstructive sleep apnea\n* serious medical illness\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03375905', 'briefTitle': 'Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sommetrics, Inc.'}, 'officialTitle': 'Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)', 'orgStudyIdInfo': {'id': 'SOM-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cNEP', 'description': 'cNEP treatment', 'interventionNames': ['Device: cNEP']}], 'interventions': [{'name': 'cNEP', 'type': 'DEVICE', 'otherNames': ['continuous negative external pressure'], 'description': 'subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas', 'armGroupLabels': ['cNEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96744', 'city': 'Kaneohe', 'state': 'Hawaii', 'country': 'United States', 'facility': 'The Sleep Lab', 'geoPoint': {'lat': 21.39994, 'lon': -157.79895}}], 'overallOfficials': [{'name': 'Jamil S Sulieman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Sleep Lab, Kaneohe, HI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sommetrics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}