Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 6:59 PM
Study NCT ID:
NCT01797705
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2013-01-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jim.Froehlich@devilbisshc.com', 'phone': '814-443-7692', 'title': 'Jim Froehlich', 'organization': 'DeVilbiss Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse events were assessed for the period from patient's enrollment in the study up to termination (the morning following the one-night sleep study).", 'description': 'Adverse events were assessed per a list of probable events associated with use of CPAP equipment. There were no adverse events for the analysis population.', 'eventGroups': [{'id': 'EG000', 'title': 'Evaluable Subjects', 'description': 'All subjects completing the one-night sleep study with evaluable results.', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Evaluable Subjects', 'description': 'All subjects completing the one-night sleep study with evaluable results.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '94.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 night', 'description': 'The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch.', 'unitOfMeasure': 'percentage of agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects completing the study with evaluable results'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'All enrolled subjects'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Equipment anomalies during sleep studies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Evaluable Subjects', 'description': 'All subjects completing the one-night sleep study with evaluable results.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'spread': '13.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Apnea Type at Enrollment', 'classes': [{'title': 'Obstructive Sleep Apnea', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Central Sleep Apnea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with obstructive vs central apnea at enrollment', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects completing the study with evaluable results'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2013-01-08', 'resultsFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-10', 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study', 'timeFrame': '1 night', 'description': 'The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apnea hypopnea index ≥ 15 / hour of sleep on the diagnostic polysomnogram, or diagnostic component of a split night polysomnogram\n* Sleep efficiency reported on CPAP titration night PSG should be \\> 78%\n* Diagnosis of moderate to severe obstructive sleep apnea (AHI ≥15) or central/complex sleep apnea\n* On stable CPAP or APAP \\[Automatic Positive Airway Pressure\\] therapy, with compliant use averaging 4 or more hours nightly\n* Age 21-75 years\n* Predominately central sleep apnea for up to 10 subjects only\n* Willingness to give written informed consent and ability to adhere to visit schedule\n\nExclusion Criteria:\n\nDiagnosis of mild sleep apnea\n\n* CPAP naïve patients\n* Co-morbid conditions which render participation to be at risk. These may include patients with congestive heart failure, COPD \\[Chronic Obstructive Pulmonary Disease\\] or psychiatric illness\n* Allergies to mask materials\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* 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* Have a bi-level requirement, or prescribed a bi-level therapy device\n* CPAP pressure \\>15cmH2O\n* Subjects with tracheotomy\n* Uncontrolled hypertension\n* Require supplemental oxygen\n* Stimulants, major tranquillizers or antipsychotics\n* Restless Leg Syndrome or Periodic Leg Movement Index of \\> 5 per hour'}, 'identificationModule': {'nctId': 'NCT01797705', 'briefTitle': 'Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'DeVilbiss Healthcare LLC'}, 'officialTitle': 'Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP', 'orgStudyIdInfo': {'id': 'DHC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'description': 'All subjects underwent a sleep study with DeVilbiss AutoAdjust CPAP with revised algorithm simultaneously with hand-scored PSG.', 'interventionNames': ['Device: DeVilbiss AutoAdjust CPAP with revised algorithm']}], 'interventions': [{'name': 'DeVilbiss AutoAdjust CPAP with revised algorithm', 'type': 'DEVICE', 'description': 'Subjects attended a one-night polysomnogram (PSG) titration study. DeVilbiss AutoAdjust CPAP with a revised algorithm was compared to hand-scored PSG to determine whether the machine results were equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure.', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02459', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NeuroCare, Inc.', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DeVilbiss Healthcare LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}