{ "FullStudy":{ "Rank":217717, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517750", "OrgStudyIdInfo":{ "OrgStudyId":"FPH-OSA-TS-2012" }, "Organization":{ "OrgFullName":"Fisher and Paykel Healthcare", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence" }, "StatusModule":{ "StatusVerifiedDate":"June 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 22, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 10, 2015", "ResultsFirstSubmitQCDate":"June 21, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 24, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 21, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 24, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Fisher and Paykel Healthcare", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Helios Klinik Ambrock", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of the only technological advancements shown to increase adherence is heated humidification, now considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to conventional humidification in reducing side effects, condensation and titrated pressure as well as increasing total sleep time. However, improved humidity delivery has not lead to significantly increased adherence in unselected obstructive sleep apnea (OSA) patients.\n\nA total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a single blind, randomized, parallel-arm trial to determine whether the the use of heated humidification will impact therapy adherence." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Sleep Apnea, Obstructive" ] }, "KeywordList":{ "Keyword":[ "Obstructive Sleep Apnea", "Humidification", "Continuous Positive Airway Pressure", "ICON", "ThermoSmart" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"80", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"APAP with humidification", "ArmGroupType":"Experimental", "ArmGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: ICON Auto CPAP™ with Thermosmart heated tube" ] } },{ "ArmGroupLabel":"APAP without humidification", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: ICON Auto CPAP™ without Thermosmart heated tube" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"ICON Auto CPAP™ with Thermosmart heated tube", "InterventionDescription":"ICON Auto CPAP™ with heated humidification and the use of a heated tube", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "APAP with humidification" ] } },{ "InterventionType":"Device", "InterventionName":"ICON Auto CPAP™ without Thermosmart heated tube", "InterventionDescription":"ICON Auto CPAP™ without heated humidification or the use of a heated tube.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "APAP without humidification" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Therapy Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software With and Without Heated Humidification.", "PrimaryOutcomeTimeFrame":"6 weeks after patient randomization" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Epworth Sleepiness Score (ESS)", "SecondaryOutcomeDescription":"The ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness", "SecondaryOutcomeTimeFrame":"6 weeks after patient randomization" },{ "SecondaryOutcomeMeasure":"Functional Outcome of Sleep Questionnaire (FOSQ)", "SecondaryOutcomeDescription":"FOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = \"I don't do this activity for other reasons\", 1=\"Yes extremely\", 2=\"Yes moderately\", 3= \"Yes a little\", 4 = \"No\". Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities.", "SecondaryOutcomeTimeFrame":"6 weeks after patient randomization" },{ "SecondaryOutcomeMeasure":"Nasopharyngeal Complaints", "SecondaryOutcomeDescription":"Nasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 (\"no complaints\") to 5 (\"very strong\"). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25.", "SecondaryOutcomeTimeFrame":"6 weeks after patient randomization" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosed with OSA\nNaïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years\nPrescribed a nasal mask (as patients will be prescribed their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn)\n\nExclusion Criteria:\n\nSevere heart disease\nCo-existing lung disease\nCo-existing sleep disorders\nPregnant", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Georg Nilius, Dr.", "OverallOfficialAffiliation":"Helios Klinik Ambrock", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Helios - Klinik Ambrock", "LocationCity":"Hagen", "LocationState":"Weg", "LocationZip":"60", "LocationCountry":"Germany" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25957615", "ReferenceType":"derived", "ReferenceCitation":"Nilius G, Franke KJ, Domanski U, Schroeder M, Ruhle KH. Effect of APAP and heated humidification with a heated breathing tube on adherence, quality of life, and nasopharyngeal complaints. Sleep Breath. 2016 Mar;20(1):43-9. doi: 10.1007/s11325-015-1182-2. Epub 2015 May 10." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Sponsor Site", "SeeAlsoLinkURL":"http://www.fphcare.co.nz/" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"APAP Without Humidification + Low RIsks of NPC", "FlowGroupDescription":"ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"APAP With Humidification + Low Risks of NPC", "FlowGroupDescription":"ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"APAP With Humidification + High Risks of NPC", "FlowGroupDescription":"ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"APAP Without Humidification + High RIsks of NPC", "FlowGroupDescription":"ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"21" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"19" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"21" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"19" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"20" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"17" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"17" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"18" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"APAP With Humidification + Low Risks of NPC", "BaselineGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"APAP Without Humidification + Low RIsks of NPC", "BaselineGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"APAP With Humidification + High Risks of NPC", "BaselineGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"APAP Without Humidification + High Risks of NPC", "BaselineGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"17" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"20" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"17" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"18" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"72" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"51.6", "BaselineMeasurementSpread":"9.8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"54.3", "BaselineMeasurementSpread":"8.8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50.9", "BaselineMeasurementSpread":"6.8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"52.1", "BaselineMeasurementSpread":"8.7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"52.3", "BaselineMeasurementSpread":"8.5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"15" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"57" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Germany", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"72" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Therapy Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software With and Without Heated Humidification.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"minutes", "OutcomeMeasureTimeFrame":"6 weeks after patient randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"APAP With Humidification + Low Risks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"APAP Without Humidification + Low RIsks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"APAP With Humidification + High Risks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"APAP Without Humidification + High RIsks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"20" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"330", "OutcomeMeasurementSpread":"116" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"321", "OutcomeMeasurementSpread":"89" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"330", "OutcomeMeasurementSpread":"103" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"281", "OutcomeMeasurementSpread":"118" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Epworth Sleepiness Score (ESS)", "OutcomeMeasureDescription":"The ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"6 weeks after patient randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"APAP With Humidification + Low Risks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"APAP Without Humidification + Low RIsks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"APAP With Humidification + High Risks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"APAP Without Humidification + High RIsks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"20" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementSpread":"5.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.9", "OutcomeMeasurementSpread":"4.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementSpread":"3.5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"9.1", "OutcomeMeasurementSpread":"3.9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Functional Outcome of Sleep Questionnaire (FOSQ)", "OutcomeMeasureDescription":"FOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = \"I don't do this activity for other reasons\", 1=\"Yes extremely\", 2=\"Yes moderately\", 3= \"Yes a little\", 4 = \"No\". Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"6 weeks after patient randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"APAP With Humidification + Low Risks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"APAP Without Humidification + Low RIsks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"APAP With Humidification + High Risks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"APAP Without Humidification + High RIsks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"20" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"91.7", "OutcomeMeasurementSpread":"7.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"91.7", "OutcomeMeasurementSpread":"14.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"90.0", "OutcomeMeasurementSpread":"11.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"82.0", "OutcomeMeasurementSpread":"12" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Nasopharyngeal Complaints", "OutcomeMeasureDescription":"Nasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 (\"no complaints\") to 5 (\"very strong\"). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"6 weeks after patient randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"APAP With Humidification + Low Risks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"APAP Without Humidification + Low RIsks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"APAP With Humidification + High Risks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"APAP Without Humidification + High RIsks of NPC", "OutcomeGroupDescription":"ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"20" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.4", "OutcomeMeasurementSpread":"4.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.3", "OutcomeMeasurementSpread":"3.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5.4", "OutcomeMeasurementSpread":"3.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"10.7", "OutcomeMeasurementSpread":"6.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Post-Hoc", "OutcomeMeasureTitle":"Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"6 weeks after randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Previous ENT Surgeries + Humidification" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Previous ENT Surgeries + Without Humidification" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Without Previous ENT Surgeries + Humidification" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"WIthout Previous ENT Surgeries + WIthout Humidification" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"18" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"20" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"NPC (Nasopharyngeal complaints)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementSpread":"4.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.8", "OutcomeMeasurementSpread":"6.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.9", "OutcomeMeasurementSpread":"3.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7.5", "OutcomeMeasurementSpread":"4.2" } ] } } ] } },{ "OutcomeClassTitle":"ESS (Epworth sleepiness score)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.3", "OutcomeMeasurementSpread":"5.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.1", "OutcomeMeasurementSpread":"4.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5.5", "OutcomeMeasurementSpread":"3.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementSpread":"4.7" } ] } } ] } },{ "OutcomeClassTitle":"FOSQ (Functional outcome of sleep questionnaire", 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