Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-02 @ 5:26 AM
Study NCT ID:
NCT00988351
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Richard.Berry@medicine.ufl.edu', 'phone': '3522621575', 'title': 'Dr. Richard B. Berry', 'organization': 'Malcom Randall VA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Carefully selected group with male predominance'}}, 'adverseEventsModule': {'timeFrame': 'Study duration', 'eventGroups': [{'id': 'EG000', 'title': 'PSG CPAP Titration Then CPAP Treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment\n\nContinuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration', 'otherNumAtRisk': 78, 'otherNumAffected': 19, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.\n\nAuto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)', 'otherNumAtRisk': 78, 'otherNumAffected': 12, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'PAP treatment intolerance', 'notes': 'unable to use PAP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'PAP intolerance'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive Airway Pressure Adherence (Nightly Use of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG CPAP Titration Then CPAP Treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment\n\nContinuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration'}, {'id': 'OG001', 'title': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.\n\nAuto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.99', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '-.35', 'ciUpperLimit': '1.26', 'pValueComment': 'level of significance \\<0.05, Power = 0.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin -0.55 (mean hours of APAP arm no lower than 0.55 hours below CPAP arm)'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after starting treatment', 'description': 'average nightly hours of using positive airway pressure (including 0 for nights not used)', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'patients using cpap or apap at clinic visit'}, {'type': 'SECONDARY', 'title': 'Change in Epworth Sleepiness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG CPAP Titration Then CPAP Treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment\n\nContinuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration'}, {'id': 'OG001', 'title': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.\n\nAuto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.65', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '2.1', 'groupDescription': 'Patients using PAP (average of \\>=1/2 hour per night) at 6 weeks clinic visit', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after starting treatment', 'description': 'Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Functional Outcomes of Sleep Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG CPAP Titration Then CPAP Treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment\n\nContinuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration'}, {'id': 'OG001', 'title': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.\n\nAuto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '2.1', 'pValueComment': '\\< 0.05 criteria for statistical significance', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.71', 'groupDescription': 'Patients using PAP (average \\>=1/2 hour per nightly use) at 6 weeks clinic visit', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 weeks at clinic', 'description': 'The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Using PAP 1/2 hour or more nightly'}, {'type': 'SECONDARY', 'title': 'Residual Apnea-hypopnea Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG CPAP Titration Then CPAP Treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment\n\nContinuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration'}, {'id': 'OG001', 'title': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.\n\nAuto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.49', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '2.29', 'groupDescription': 'Patients using PAP (average \\>= 1/2 hour of nightly use) at 6 weeks clinic visit', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'over first 6 weeks of treatment', 'description': 'The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI \\< 10 is considered adequate treatment and \\<5/hour ideal treatment.', 'unitOfMeasure': 'events (apneas+hypopneas)/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants using PAP at clinic visit (\\>= 1/2 hour of nightly use)'}, {'type': 'SECONDARY', 'title': 'Treatment Pressure (Level of CPAP or 90th Percentile APAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG CPAP Titration Then CPAP Treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment\n\nContinuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration'}, {'id': 'OG001', 'title': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.\n\nAuto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '- 0.92', 'ciLowerLimit': '-1.92', 'ciUpperLimit': '0.09', 'pValueComment': 'P \\< 0.05 considered statistically significant', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'groupDescription': 'participants using PAP (average \\>=1/2 hour of use) at 6 weeks clinic visit', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 weeks clinic', 'description': 'The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants using PAP at the 6 weeks clinic visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PSG CPAP Titration Then CPAP Treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment\n\nContinuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration'}, {'id': 'FG001', 'title': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.\n\nAuto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'CPAP Titration', 'achievements': [{'comment': '8 declined CPAP treatment', 'groupId': 'FG000', 'numSubjects': '78'}, {'comment': 'no titration needed', 'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'PAP Setup', 'achievements': [{'comment': 'CPAP treatment started', 'groupId': 'FG000', 'numSubjects': '70'}, {'comment': 'APAP treatment started', 'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'Clinic Visit', 'achievements': [{'comment': '6 lost to follow-up or no show for clinic', 'groupId': 'FG000', 'numSubjects': '64'}, {'comment': '9 lost to follow-up or no show for clinic', 'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Using CPAP or APAP', 'achievements': [{'comment': '5 not using CPAP (use \\< 1/2 hour per night)', 'groupId': 'FG000', 'numSubjects': '59'}, {'comment': '3 not using APAP (less than 1/2 hour per night)', 'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'not using CPAP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PSG CPAP Titration Then CPAP Treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment\n\nContinuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration'}, {'id': 'BG001', 'title': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.\n\nAuto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '34.6', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'measure weight and height compute as kg divided by height squared', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'apnea+hypopnea index', 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'spread': '19.1', 'groupId': 'BG000'}, {'value': '28.6', 'spread': '18.2', 'groupId': 'BG001'}, {'value': '29.8', 'spread': '18.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'AHI from Home sleep apnea test', 'unitOfMeasure': 'number of apneas and hypopneas /hour', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Apnea+hypopnea index \\>= 10/hour'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2009-10-01', 'resultsFirstSubmitDate': '2014-03-23', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-30', 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Airway Pressure Adherence (Nightly Use of Treatment)', 'timeFrame': '6 weeks after starting treatment', 'description': 'average nightly hours of using positive airway pressure (including 0 for nights not used)'}], 'secondaryOutcomes': [{'measure': 'Change in Epworth Sleepiness Scale', 'timeFrame': '6 weeks after starting treatment', 'description': 'Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.'}, {'measure': 'Change in Functional Outcomes of Sleep Questionnaire', 'timeFrame': '6 weeks at clinic', 'description': 'The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.'}, {'measure': 'Residual Apnea-hypopnea Index', 'timeFrame': 'over first 6 weeks of treatment', 'description': 'The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI \\< 10 is considered adequate treatment and \\<5/hour ideal treatment.'}, {'measure': 'Treatment Pressure (Level of CPAP or 90th Percentile APAP)', 'timeFrame': '6 weeks clinic', 'description': 'The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep apnea', 'positive airway pressure', 'portable monitoring', 'auto positive airway pressure'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.', 'detailedDescription': "RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep Education and Evaluation Class before having a sleep study. At this class they receive information on sleep apnea, PAP treatment, and the types of sleep studies. They also complete a sleep questionnaire to identify co-existing sleep disorders and important co-morbid medical conditions. Screening of the sleep questionnaire and the patient's medical record is part of routine care to identify patients needing a diagnostic PSG and/or an attended titration. At the end of the class, participation in the current study will be offered the patients. Those signifying interest in being part of the research study and meeting inclusion and exclusion criteria will be contacted to participate in the study. Once they sign an informed consent they will be randomized to one of the two clinical pathways.\n\nMETHODS: Study visits:\n\nBefore informed consent (routine clinical care)\n\n1. Sleep Education and Evaluation Class (education about OSA, sleep studies, and OSA treatment). Patients complete screening sleep and medical history questionnaires.\n2. Determination of patient interest in participating in the current study and review of inclusion/exclusion criteria\n\nAfter informed consent\n\n1. PM study\n2. Randomization if the Portable monitoring (PM) study is diagnostic of OSA. If not, the patient will be offered a diagnostic PSG. If this is positive, they will have APAP treatment. If both the PM and PSG are negative for OSA the patient exits the study but will be followed in sleep clinic.\n3. PSG for CPAP titration (PSG arm only).\n4. CPAP/APAP setup - patient fills out Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ). The same Research coordinator/Respiratory therapist will setup the units, fit masks, and instruct the patients on the use of their device. Patients being treated with CPAP or APAP will be in separate classes.\n5. Telephone contact within 7 days of setup with early intervention for PAP problems if needed.\n6. Clinic visit 6 weeks after starting treatment: download objective adherence, ESS, FOSQ, and PAP satisfaction questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OSA, Apnea-hypopnea index \\> 5/hour\n\nExclusion Criteria:\n\n* Prior CPAP\n* Uncontrolled Depression\n* Moderate to Severe chronic obstructive pulmonary disease (COPD)\n* Hypoventilation\n* Average estimated nightly total sleep time \\< 4 hours\n* Shift work\n* Unstable depression\n* Upper airway surgery\n* Uncontrolled Restless legs syndrome (RLS), narcolepsy\n* Use of supplemental oxygen\n* Severe congestive heart failure\n* Use of nightly potent narcotics\n* Severe obesity (BMI \\> 40)'}, 'identificationModule': {'nctId': 'NCT00988351', 'briefTitle': 'Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'North Florida Foundation for Research and Education'}, 'officialTitle': 'Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA', 'orgStudyIdInfo': {'id': 'UFIRB#384-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PSG CPAP titration then CPAP treatment', 'description': 'Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment', 'interventionNames': ['Device: Continuous positive airway pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Auto-Adjusting Positive Airway Pressure', 'description': 'Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.', 'interventionNames': ['Device: Auto-adjusting positive airway pressure treatment']}], 'interventions': [{'name': 'Continuous positive airway pressure', 'type': 'DEVICE', 'otherNames': ['CPAP'], 'description': 'continuous positive airway pressure determined by polysomnography titration', 'armGroupLabels': ['PSG CPAP titration then CPAP treatment']}, {'name': 'Auto-adjusting positive airway pressure treatment', 'type': 'DEVICE', 'otherNames': ['AutoCPAP', 'APAP'], 'description': 'Pressure range 4-18 centimeters of water (cm H2O)', 'armGroupLabels': ['Auto-Adjusting Positive Airway Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Malcom Randall VA Medical Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Richard B Berry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida/Malcom Randall VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Florida Foundation for Research and Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine University of Florida', 'investigatorFullName': 'Richard Berry', 'investigatorAffiliation': 'North Florida Foundation for Research and Education'}}}}