Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-03 @ 2:01 AM
Study NCT ID:
NCT01831258
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2013-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
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': 'rbogan@sleepmedinc.com', 'phone': '8777537633', 'title': 'Dr Richard Bogan', 'organization': 'SleepMed of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year and 1 month', 'eventGroups': [{'id': 'EG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on", 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 11, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off", 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 16, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Mask related issues', 'notes': '11 events were related to the mask, it was not related to the device. There were sore on nose, skin breakdown from mask and mask irritations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold or Upper Respiratory Infections', 'notes': 'Cold or Upper Respiratory Infections. They were not related to the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken Arm', 'notes': 'Broken Arm not related to the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness upon Arousal', 'notes': 'Not related to the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pressure related problems', 'notes': 'Feeling higher pressure from the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Scheduled Achilles Tendon Surgery', 'notes': 'Not related to the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'High Blood Pressure', 'notes': 'Participant was hospitalized with symptoms of extremely high blood pressure. No formal diagnosis was given prior to discharge however subjects were placed on hypertension medication. PI deemed as not related to the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to CPAP Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '272.672', 'spread': '17.055', 'groupId': 'OG000'}, {'value': '289.087', 'spread': '15.239', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Average used minutes (all days) taken from the CPAP device.', 'unitOfMeasure': 'mins', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Adherence data could only be obtained for 61 participants'}, {'type': 'SECONDARY', 'title': 'Daytime Sleepiness (Subjective Sleep Quality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 65 participant were available'}, {'type': 'SECONDARY', 'title': 'Insomnia Severity Index (Subjective Sleep Quality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 63 participant were available'}, {'type': 'SECONDARY', 'title': 'OSA Impact of Daily Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 62 participant were available'}, {'type': 'SECONDARY', 'title': 'OSA Impact of Daily Life (Fatigue)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 64 participant were available'}, {'type': 'SECONDARY', 'title': 'Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 64 participant were available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Leak', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on\n\nSensAwake On"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off\n\nSensAwake Off"}], 'classes': [{'categories': [{'measurements': [{'value': '41.72', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '48.91', 'spread': '3.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One night', 'description': 'The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Obtained only 61 participant CPAP data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Apnea Hypopnea Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '5.182', 'spread': '0.590', 'groupId': 'OG000'}, {'value': '3.563', 'spread': '0.464', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Collected through the device', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 61 participant data was available.'}, {'type': 'POST_HOC', 'title': 'Adherence in Patients With Signs of Moderate Clinical Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '322.89', 'spread': '26.46', 'groupId': 'OG000'}, {'value': '282.25', 'spread': '30.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Adherence from the device (during their first treatment arm) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.'}, {'type': 'POST_HOC', 'title': 'Adherence in Patients With Signs of Moderate Clinical Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '304.787', 'spread': '28.75', 'groupId': 'OG000'}, {'value': '238.42', 'spread': '35.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Adherence from the device (during their entire study period) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.'}, {'type': 'SECONDARY', 'title': 'Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on"}, {'id': 'OG001', 'title': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off"}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?". The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for 64 participant were available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SensAwake On, Then Followed by SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned on, followed by it off."}, {'id': 'FG001', 'title': 'SensAwake Off, Then Followed by SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned off, then followed by on."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants who were randomized to receive either SensAwake On or SensAwake Off'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50.78', 'spread': '11.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only collected 65 participants data on age'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only collected n=68. Missing data for 2 participants.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-20', 'studyFirstSubmitDate': '2013-04-02', 'resultsFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2013-04-12', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-20', 'studyFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Leak', 'timeFrame': 'One night', 'description': 'The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device'}, {'measure': 'Apnea Hypopnea Index (AHI)', 'timeFrame': '2 weeks', 'description': 'Collected through the device'}], 'primaryOutcomes': [{'measure': 'Adherence to CPAP Treatment', 'timeFrame': '2 weeks', 'description': 'Average used minutes (all days) taken from the CPAP device.'}], 'secondaryOutcomes': [{'measure': 'Daytime Sleepiness (Subjective Sleep Quality)', 'timeFrame': '4 weeks', 'description': 'Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.'}, {'measure': 'Insomnia Severity Index (Subjective Sleep Quality)', 'timeFrame': '4 weeks', 'description': 'Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).'}, {'measure': 'OSA Impact of Daily Life', 'timeFrame': '4 weeks', 'description': 'Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.'}, {'measure': 'OSA Impact of Daily Life (Fatigue)', 'timeFrame': '4 weeks', 'description': 'Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.'}, {'measure': 'Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity', 'timeFrame': '4 weeks', 'description': 'Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.'}, {'measure': 'Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change', 'timeFrame': '4 weeks', 'description': 'Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?". The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.'}]}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \\& Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.\n\nThe purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology.\n\nIt is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).\n* Successful in-lab titration polysomnography (PSG)\n* General (at home) sleep habits of:\n* At least 7 hours in bed on most nights\n* Lights out at 12 midnight or earlier\n* Fluency in both written and spoken English.\n\nExclusion Criteria:\n\n* Participants prescribed and fitted with any PAP device in the past 2 years\n* Contraindicated for CPAP or AutoCPAP therapy.\n* Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.\n* Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.\n* Patients who are prescribed hypnotics and sedating medications.\n* Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months.\n* If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.\n* If the physician objects to their patient taking part in the study.'}, 'identificationModule': {'nctId': 'NCT01831258', 'briefTitle': 'Comparison Study of the ICON™ CPAP Series With and Without SensAwake™', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'orgStudyIdInfo': {'id': 'FPH-SA13-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SensAwake On', 'description': "The comfort feature 'SensAwake' will be turned on", 'interventionNames': ['Device: SensAwake On']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SensAwake Off', 'description': "The comfort feature 'SensAwake' will be turned off", 'interventionNames': ['Device: SensAwake Off']}], 'interventions': [{'name': 'SensAwake On', 'type': 'DEVICE', 'armGroupLabels': ['SensAwake On']}, {'name': 'SensAwake Off', 'type': 'DEVICE', 'armGroupLabels': ['SensAwake Off']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'SleepMed of Central Georgia', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Sleep Med of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}