Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT01241604
Status:
TERMINATED
Last Update Posted:
2019-04-09
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeremy.powers@philips.com', 'phone': '412-542-3669', 'title': 'Jeremy Powers', 'organization': 'Philips Respironics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 nights', 'eventGroups': [{'id': 'EG000', 'title': 'Screening Period', 'description': 'All participants that were consented into the study.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3', 'description': 'Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T', 'description': 'Auto Servo Ventilation Device first and then Mechanical Non-invasive Ventilation', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Apnea Hypopnea Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '19.24', 'spread': '16.72', 'groupId': 'OG000'}, {'value': '15.85', 'spread': '17.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.753', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon signed ranks test', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalent non-parametric tests'}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The number of apneas and hypopneas per hour of sleep.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Apnea Hypopnea Index- REM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '10.16', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '4.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Central Apnea Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The central apnea index is the number of central apneas divided by the number of hours of sleep.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Obstructive Apnea Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The obstructive apnea index is the number of obstructive apneas per hour of sleep.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Mixed Apnea Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Hypopnea Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'spread': '16.54', 'groupId': 'OG000'}, {'value': '15.74', 'spread': '17.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The hypopnea index is number hypopneas per hour.', 'unitOfMeasure': 'events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Sleep Onset Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '43.25', 'spread': '41.98', 'groupId': 'OG000'}, {'value': '64.58', 'spread': '81.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'REM Onset Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'timeFrame': '2 nights', 'description': 'REM Onset Latency is the time it takes to fall into REM sleep.', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done because this is not a standard measurement.'}, {'type': 'SECONDARY', 'title': 'Wake After Sleep Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '72.58', 'spread': '63.25', 'groupId': 'OG000'}, {'value': '67.67', 'spread': '39.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '331.83', 'spread': '66.7', 'groupId': 'OG000'}, {'value': '352.67', 'spread': '63.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'Total Sleep time is total amount of time a participant is asleep from lights off to lights on.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '74.78', 'spread': '12.36', 'groupId': 'OG000'}, {'value': '73.42', 'spread': '16.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'Sleep Efficiency is the percentage of time spent asleep while in bed.', 'unitOfMeasure': 'percentage of time asleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Periodic Limb Movement Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '7.32', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '4', 'spread': '5.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The periodic limb movement is the number of periodic limb movements per hour of sleep.', 'unitOfMeasure': 'movements per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Arousal Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '27.33', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '23.76', 'spread': '15.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The arousal index is the number of arousals or awakenings per hour of sleep.', 'unitOfMeasure': 'arousals per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Stages N1,N2,N3 and REM (R) Sleep (% TST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'title': 'Stage N1', 'categories': [{'measurements': [{'value': '2.16', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Stage N2', 'categories': [{'measurements': [{'value': '82.48', 'spread': '15.54', 'groupId': 'OG000'}, {'value': '83.44', 'spread': '9.01', 'groupId': 'OG001'}]}]}, {'title': 'Stage N3', 'categories': [{'measurements': [{'value': '4.1', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '8.06', 'groupId': 'OG001'}]}]}, {'title': 'REM', 'categories': [{'measurements': [{'value': '11.26', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '10.92', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.', 'unitOfMeasure': 'percentage of TST per night', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Stages N1,N2,N3 and REM (R) Sleep (in Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'title': 'Stage N1', 'categories': [{'measurements': [{'value': '7.17', 'spread': '10.46', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '3.33', 'groupId': 'OG001'}]}]}, {'title': 'Stage N2', 'categories': [{'measurements': [{'value': '271.33', 'spread': '70.03', 'groupId': 'OG000'}, {'value': '294.92', 'spread': '67.18', 'groupId': 'OG001'}]}]}, {'title': 'Stage N3', 'categories': [{'measurements': [{'value': '15.25', 'spread': '28.02', 'groupId': 'OG000'}, {'value': '17.25', 'spread': '23.01', 'groupId': 'OG001'}]}]}, {'title': 'REM', 'categories': [{'measurements': [{'value': '37.92', 'spread': '32.74', 'groupId': 'OG000'}, {'value': '37.67', 'spread': '17.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': 'The average amount of time spent N1, N2, N3 and REM in minutes per night.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Nocturnal Oxygenation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '19.93', 'spread': '19.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 nights', 'description': "Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.", 'unitOfMeasure': 'oxygen saturation index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.\n\nOne subject had no pain related medical history and therefore was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Apnea Hypopnea Index Using Modified Hypopnea Rule.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'timeFrame': '2 nights', 'description': 'The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Apnea Hyopnea Index(AHI) was analyzed and results were provided. The AHI using the modified hypopnea rule was not conducted. This is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.'}, {'type': 'SECONDARY', 'title': 'Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T\n\nBiPAP S/T: Mechanical Non-invasive Ventilation'}, {'id': 'OG001', 'title': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3\n\nBiPAP Auto SV3: Auto Servo Ventilation Device'}], 'timeFrame': '2 nights', 'description': 'The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Apnea Hypopnea Index (AHI) was analyzed and results were provided. However the epochs were not separated out as this is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screening Population', 'description': 'All participants that signed consent are considered for the screening population.'}, {'id': 'FG001', 'title': 'Respironics BiPAP S/T First, Then Respironics BiPAP Auto SV3', 'description': 'Mechanical Non-invasive Ventilation first and then Auto Servo Ventilation Device'}, {'id': 'FG002', 'title': 'Respironics BiPAP Auto SV3 First, Then Respironics BiPAP S/T', 'description': 'Auto Servo Ventilation Device and then Mechanical Non-invasive Ventilation'}], 'periods': [{'title': 'Screening Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from one site to evaluate software enhancements. The study enrolled patients in the spring of 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants that were consented.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'spread': '3.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The patients that were found eligible and were randomized are included in the baseline analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Sub par recruitment performance', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-15', 'studyFirstSubmitDate': '2009-06-02', 'resultsFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-15', 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea Hypopnea Index', 'timeFrame': '2 nights', 'description': 'The number of apneas and hypopneas per hour of sleep.'}], 'secondaryOutcomes': [{'measure': 'Apnea Hypopnea Index- REM', 'timeFrame': '2 nights', 'description': 'The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).'}, {'measure': 'Central Apnea Index', 'timeFrame': '2 nights', 'description': 'The central apnea index is the number of central apneas divided by the number of hours of sleep.'}, {'measure': 'Obstructive Apnea Index', 'timeFrame': '2 nights', 'description': 'The obstructive apnea index is the number of obstructive apneas per hour of sleep.'}, {'measure': 'Mixed Apnea Index', 'timeFrame': '2 nights', 'description': 'The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.'}, {'measure': 'Hypopnea Index', 'timeFrame': '2 nights', 'description': 'The hypopnea index is number hypopneas per hour.'}, {'measure': 'Sleep Onset Latency', 'timeFrame': '2 nights', 'description': 'Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.'}, {'measure': 'REM Onset Latency', 'timeFrame': '2 nights', 'description': 'REM Onset Latency is the time it takes to fall into REM sleep.'}, {'measure': 'Wake After Sleep Onset', 'timeFrame': '2 nights', 'description': 'Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.'}, {'measure': 'Total Sleep Time', 'timeFrame': '2 nights', 'description': 'Total Sleep time is total amount of time a participant is asleep from lights off to lights on.'}, {'measure': 'Sleep Efficiency', 'timeFrame': '2 nights', 'description': 'Sleep Efficiency is the percentage of time spent asleep while in bed.'}, {'measure': 'Periodic Limb Movement Index', 'timeFrame': '2 nights', 'description': 'The periodic limb movement is the number of periodic limb movements per hour of sleep.'}, {'measure': 'Arousal Index', 'timeFrame': '2 nights', 'description': 'The arousal index is the number of arousals or awakenings per hour of sleep.'}, {'measure': 'Stages N1,N2,N3 and REM (R) Sleep (% TST)', 'timeFrame': '2 nights', 'description': 'The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.'}, {'measure': 'Stages N1,N2,N3 and REM (R) Sleep (in Minutes)', 'timeFrame': '2 nights', 'description': 'The average amount of time spent N1, N2, N3 and REM in minutes per night.'}, {'measure': 'Nocturnal Oxygenation Index', 'timeFrame': '2 nights', 'description': "Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline."}, {'measure': 'Apnea Hypopnea Index Using Modified Hypopnea Rule.', 'timeFrame': '2 nights', 'description': 'The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.'}, {'measure': 'Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.', 'timeFrame': '2 nights', 'description': 'The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep Disordered Breathing']}, 'descriptionModule': {'briefSummary': "This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.", 'detailedDescription': "Primary Hypothesis and end-point:\n\nThe use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to:\n\n* Apnea-Hypopnea Index (AHI)\n\nSecondary Hypothesis and end-points:\n\nThe use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to:\n\n* Sleep Variables\n* REM, NREM and Total Sleep Time (TST) Indices\n* Apnea Hypopnea Index (AHI)\n* Center Apnea Index(CAI)\n* Obstructive Apnea Index (OAI)\n* Mixed Apnea Index (MAI)\n* Hypopnea Index (HI)\n* Sleep Onset Latency (SOL)\n* REM Onset Latency (ROL)\n* Wake After Sleep Onset (WASO)\n* Total Sleep Time (TST)\n* Sleep Efficiency (SE %)\n* Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes)\n* Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST)\n* Arousal Index \\[total, AH-related, PLM-related, 'spontaneous'\\]\n* Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study)\n* AHI (REM, NREM and TST) using modified hypopnea rule.\n* AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-80.\n* Ability to provide consent.\n* Documentation of medical stability by investigator.\n* Currently using BiPAP S/T (At least 4 weeks on therapy).\n* Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.\n\nExclusion Criteria:\n\n* Participants, who are acutely ill, medically complicated or who are medically unstable.\n* Participants in whom PAP therapy is otherwise medically contraindicated.\n* Participants who are unwilling to wear PAP.\n* Participants who are currently prescribed oxygen therapy.\n* Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).\n* Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.\n* Participants with untreated, non-obstructive sleep apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome Periodic Limb Movement (PLM) Arousal Index \\> 15).\n* Participants who are unwilling to participate in the study.'}, 'identificationModule': {'nctId': 'NCT01241604', 'acronym': 'SV3-ST', 'briefTitle': 'Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Respironics'}, 'officialTitle': 'Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device', 'orgStudyIdInfo': {'id': 'MR-0830-ASV3-ST-SS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Respironics BiPAP S/T', 'description': 'Control Arm using Respironics BiPAP S/T', 'interventionNames': ['Device: BiPAP S/T']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Respironics BiPAP Auto SV3', 'description': 'Treatment arm using Respironics BiPAP Auto SV3', 'interventionNames': ['Device: BiPAP Auto SV3']}], 'interventions': [{'name': 'BiPAP S/T', 'type': 'DEVICE', 'otherNames': ['Respironics BiPAP S/T'], 'description': 'Mechanical Non-invasive Ventilation', 'armGroupLabels': ['Respironics BiPAP S/T']}, {'name': 'BiPAP Auto SV3', 'type': 'DEVICE', 'otherNames': ['Respironics BiPAP auto SV Advanced'], 'description': 'Auto Servo Ventilation Device', 'armGroupLabels': ['Respironics BiPAP Auto SV3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Med One Medical Sleep Laboratory', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Brydon Grant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Director of Med One Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Respironics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}