Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-03 @ 12:34 AM
Study NCT ID:
NCT02357706
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Auto-Adjusting Positive Airway Pressure Devices
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': 'ingo.fietze@charite.de', 'phone': '+49 30 450 513 122', 'title': 'Prof Dr med Ingo Fietze', 'organization': 'Charite Department of Sleepmedizin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'APAP A (AirSense)', 'description': 'APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'APAP B (Apex)', 'description': 'APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Apnoea-Hypopnoea-Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense Auto Set)', 'description': 'Patients in the "APAP A, then APAP B" group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B (Apex iCH Auto)', 'description': 'Patients in the "APAP B, then APAP A" group will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '6.21', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '7.45', 'spread': '7.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.24', 'groupDescription': 'Comparison of AHI/ oxygen desaturation index (ODI) of Device A compared with Device B.\n\nEfficacy is defined as a residual AHI and ODI on each night of the trial. PSG scored AHI and ODI will be collected on both trial nights (excluding the ramp period); and compared using the Paired T test', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B\n\nThe Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.24', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B\n\nThe Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs\n\nThe expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen).'}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)', 'description': 'AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 patients have used APAP A, for which the primary outcome was calculated. The same 20 patients have used APAP B for which the Primary outcome was calculated.'}, {'type': 'PRIMARY', 'title': 'Mean Oxygen Desaturation Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B (Apex)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '7.94', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '10.63', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.205', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.69', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B\n\nThe Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs\n\nThe expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen).'}, {'pValue': '0.134', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.69', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B\n\nThe Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs\n\nThe expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen).'}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.', 'description': 'Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Obstructive Apnoea Index (OAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B (Apex)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '0.580', 'spread': '1.525', 'groupId': 'OG000'}, {'value': '0.885', 'spread': '1.668', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of obstructive apnoeas per hour of nights sleep, Events/hour', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Central Apnoea Index (CAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '5.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of central apnoeas during hours of sleep, events/hour', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mixed Apnoea Index (MAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B (Apex)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '0.115', 'spread': '0.514', 'groupId': 'OG000'}, {'value': '0.220', 'spread': '0.744', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of obstructive and central apnoeas per hours of nights sleep, Events/hour', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypopnoea-Index HI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B (Apex)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '3.17', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '5.49', 'spread': '5.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of Hypopnoeas per hour of nights sleep, Events/hour', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Effort Related Arousals RERAs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B (Apex)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '12.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of RERAs per hour of nights sleep, Events/hour', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Flow Limitation (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B (Apex)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '49.25', 'spread': '27.61', 'groupId': 'OG000'}, {'value': '43.16', 'spread': '22.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Percent of flow-limited breaths in relation to the overall breaths at night.', 'unitOfMeasure': '% overall breaths', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean O2 Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APAP A (AirSense)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'OG001', 'title': 'APAP B (Apex)', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP B.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'classes': [{'categories': [{'measurements': [{'value': '94.210', 'spread': '2.414', 'groupId': 'OG000'}, {'value': '93.680', 'spread': '2.192', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Mean blood oxygen Saturation, %', 'unitOfMeasure': '% total hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'APAP A, Then APAP B', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}, {'id': 'FG001', 'title': 'APAP B, Then APAP A', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Patients will be randomised to either "APAP A, then APAP B" or "APAP B, then APAP A". Patients in "APAP A, then APAP B" will use APAP A on the first night of the evaluation, and APAP B on the second night. Patients in "APAP B, then APAP A" will use APAP B on the first night of the evaluation and APAP A on the second night.\n\nAPAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events\n\nAPAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'spread': '5.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Neck Size', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '3.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'waist-to-hip ratio', 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '0.06', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2015-01-27', 'resultsFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2015-02-03', 'lastUpdatePostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-08', 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Apnoea-Hypopnoea-Index (AHI)', 'timeFrame': '1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)', 'description': 'AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).'}, {'measure': 'Mean Oxygen Desaturation Index (ODI)', 'timeFrame': '1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.', 'description': 'Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour'}], 'secondaryOutcomes': [{'measure': 'Obstructive Apnoea Index (OAI)', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of obstructive apnoeas per hour of nights sleep, Events/hour'}, {'measure': 'Central Apnoea Index (CAI)', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of central apnoeas during hours of sleep, events/hour'}, {'measure': 'Mixed Apnoea Index (MAI)', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of obstructive and central apnoeas per hours of nights sleep, Events/hour'}, {'measure': 'Hypopnoea-Index HI', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of Hypopnoeas per hour of nights sleep, Events/hour'}, {'measure': 'Respiratory Effort Related Arousals RERAs', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Number of RERAs per hour of nights sleep, Events/hour'}, {'measure': 'Flow Limitation (%)', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Percent of flow-limited breaths in relation to the overall breaths at night.'}, {'measure': 'Mean O2 Saturation', 'timeFrame': '1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B', 'description': 'Mean blood oxygen Saturation, %'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged ≥ 18 years\n* Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry\n* Naive to CPAP therapy\n* Participants willing and able to give written informed consent\n\nExclusion Criteria:\n\n* Participants requiring Bi-level PAP\n* Participants requiring supplemental oxygen\n* Participants who are pregnant\n* Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\\< 2years) case of pneumonia or lung infection; lung injury)'}, 'identificationModule': {'nctId': 'NCT02357706', 'briefTitle': 'Comparison of Auto-Adjusting Positive Airway Pressure Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Comparison of Auto-Adjusting Positive Airway Pressure Devices', 'orgStudyIdInfo': {'id': 'MA240115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.', 'interventionNames': ['Device: APAP A (ResMed AirSense AutoSet)', 'Device: APAP B (Apex iCH Auto)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.', 'interventionNames': ['Device: APAP A (ResMed AirSense AutoSet)', 'Device: APAP B (Apex iCH Auto)']}], 'interventions': [{'name': 'APAP A (ResMed AirSense AutoSet)', 'type': 'DEVICE', 'otherNames': ['Auto-Adjusting Positive Airway Pressure Device A'], 'description': 'Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'APAP B (Apex iCH Auto)', 'type': 'DEVICE', 'otherNames': ['Auto-Adjusting Positive Airway Pressure Device B'], 'description': 'Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Center of Sleep Medicine, Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Ingo Fietz, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite Center of Sleep Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}