Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01203956
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2010-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
DeVilbiss AutoAdjust With SmartFlex Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012015', 'term': 'Reference Standards'}], 'ancestors': [{'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LRosenthal@sleepmed.com', 'phone': '214-750-7776', 'title': 'Leon Rosenthal, MD', 'organization': 'Sleep Medicine Associates of Texas'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'SmartFlex', 'description': 'CPAP device used with SmartFlex engaged, either in first or second two-week period.', 'otherNumAtRisk': 17, 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard', 'description': 'CPAP device used without SmartFlex engaged, either in first or second two-week period.', 'otherNumAtRisk': 17, 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'description': 'From data available it cannot be determined which mode the subject was using at the time of this event.', 'otherNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Uncomfortable breathing due to expiratory resistance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth breathing which may worsen snoring or OSA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal, sinus or middle ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness on bridge of nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiatal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pressure sore on bridge of nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Apnea-hypopnea Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SmartFlex', 'description': 'Used CPAP device with SmartFlex engaged, in either first or second two-week period.'}, {'id': 'OG001', 'title': 'Standard', 'description': 'Used CPAP device without SmartFlex engaged, in either first or second two-week period.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.92', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '5.56', 'spread': '3.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Number of apnea/hypopnea events per hour, measured by SmartLink component of device.', 'unitOfMeasure': 'events / hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Key Measures That Will be Used to Evaluate the Intervention(s)', 'timeFrame': '2 weeks', 'description': 'The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SmartFlex First, Then Standard', 'description': 'First two weeks with Smartflex engaged, second two weeks without Smartflex engaged'}, {'id': 'FG001', 'title': 'Standard First, Then Smartflex', 'description': 'First two weeks without Smartflex engaged, second two weeks with Smartflex engaged'}], 'periods': [{'title': 'First Two-week Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'All participants continued to the second two-week period, whether or not they had evaluable results.', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'All participants continued to the second two-week period, whether or not they had evaluable results.', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Two-week Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Attended Sleep Studies for 14 Nights', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed with evaluable results, as assessed over both two-week study periods.', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'Completed with evaluable results, as assessed over both two-week study periods.', 'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Non-compliant: no evaluable results', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Evaluable Subjects', 'description': 'All subjects completing both two-week periods of crossover study, with evaluable results for each period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'AHI (apnea-hypopnea index)', 'classes': [{'categories': [{'measurements': [{'value': '39.8', 'spread': '21.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'events / hour', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Compliant participants completing study with evaluable results'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2010-08-31', 'resultsFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2010-09-16', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-08', 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-hypopnea Index (AHI)', 'timeFrame': '4 weeks', 'description': 'Number of apnea/hypopnea events per hour, measured by SmartLink component of device.'}], 'secondaryOutcomes': [{'measure': 'Key Measures That Will be Used to Evaluate the Intervention(s)', 'timeFrame': '2 weeks', 'description': 'The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AutoAdjust', 'SmartFlex', 'Apnea Hypopnea Index', 'Patient reported outcomes'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Epworth Sleepiness Scale \\>10\n* Body Mass Index \\> 26\n* Apnea-hypopnea index (AHI) ≥15 (mod to severe range)\n* AHI ≤ 10 at therapeutic continuous positive airway pressure (CPAP) pressure\n* CPAP naïve patients\n* Polysomnogram (PSG) within 3 months of enrollment\n* Average oxygen saturation by pulse oximetry (SpO2) \\> 90% during titration\n* Sleep efficiency on titration night ≥ 78%\n\nExclusion Criteria:\n\n* Diagnosis of mild obstructive sleep apnea (OSA)\n* Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (COPD) or psychiatric illness\n* Allergies to mask materials\n* Difficulties with nasal breathing\n* Evidence of another primary sleep disorder\n* Evidence of arousing periodic limb movements during titration\n* Contraindications as listed on product labeling.\n* Pregnant\n* Currently diagnosed with depression if symptomatic\n* Predominately central sleep apnea\n* Deemed medically unsuitable by investigator\n* Evidence of any type of infection or treatment of an infectious condition during the period of research participation\n* Full Face Mask during titration\n* Have a bi-level requirement\n* CPAP pressure \\>15cmH2O\n* Subjects with tracheotomy\n* Uncontrolled hypertension\n* Require supplemental oxygen\n* Stimulants, major tranquillizers or antipsychotics.'}, 'identificationModule': {'nctId': 'NCT01203956', 'briefTitle': 'DeVilbiss AutoAdjust With SmartFlex Comparative Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'DeVilbiss Healthcare LLC'}, 'officialTitle': 'A Multi Center, Prospective, Randomized, Double Blind, Crossover Study to Compare the DeVilbiss AutoAdjust With and Without the Smartflex Device Modification; "AutoAdjust With SmartFlex Study"', 'orgStudyIdInfo': {'id': 'DHC-C001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SmartFlex', 'description': 'Use Continuous Airway Pressure device with SmartFlex engaged', 'interventionNames': ['Device: SmartFlex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'Use Continuous Airway Pressure device without SmartFlex engaged', 'interventionNames': ['Device: Standard']}], 'interventions': [{'name': 'SmartFlex', 'type': 'DEVICE', 'otherNames': ['DeVilbiss AutoAdjust with SmartFlex'], 'description': 'Device used with smartflex engaged.', 'armGroupLabels': ['SmartFlex']}, {'name': 'Standard', 'type': 'DEVICE', 'otherNames': ['DeVilbiss AutoAdjust without SmartFlex'], 'armGroupLabels': ['Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Medicine Associates of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy and Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Leon Rosenthal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sleep Medicine Associates of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DeVilbiss Healthcare LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}