{
  "FullStudy":{
    "Rank":218153,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512043",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2009/2/0285"
          },
          "Organization":{
            "OrgFullName":"Lovisenberg Diakonale Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD)",
          "OfficialTitle":"Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"July 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 8, 2011",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 5, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 6, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Lovisenberg Diakonale Hospital",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"University of Oslo",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Norwegian Foundation for Health and Rehabilitation",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"University of Bergen",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"There is a demand for explorative and comparative studies on various non-pharmaceutical efforts in treating and helping chronic obstructive pulmonary disease patients. This study has been developed in light of this need. The main purpose of the project is to test whether a device guided breathing control system can decreasing the feeling of breathlessness in patients with moderate stage and severe stage of COPD. In addition the study could shed light on whether a reduced feeling of breathlessness can lead to improved physical function, and less experience of other symptoms (I.e., depression, anxiety, sleeping difficulties, fatigue, pain) and provide a better quality of life for patients with COPD."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "COPD"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Breathlessness",
              "Symptoms",
              "Quality of life"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"150",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"1. Breathing control",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Description ...",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Breathing control"
                  ]
                }
              },{
                "ArmGroupLabel":"2. Listening to music",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Listening to music without guiding on breathing on the same device as breathing control twice a day for four weeks. Using the device to measure breathing movements.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Breathing control"
                  ]
                }
              },{
                "ArmGroupLabel":"3. Silence",
                "ArmGroupType":"Sham Comparator",
                "ArmGroupDescription":"Using the device to measure breathing movement twice a day for four weeks. No instruction on breathing control and no music.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Breathing control"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Breathing control",
                "InterventionDescription":"Practice of device guided breathing control twice a day for four weeks.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "1. Breathing control",
                    "2. Listening to music",
                    "3. Silence"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Breathlessness",
                "PrimaryOutcomeDescription":"Questionnaires",
                "PrimaryOutcomeTimeFrame":"4 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Depression",
                "SecondaryOutcomeDescription":"Questionnaires",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"Pulmonary functional tests",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"Anxiety",
                "SecondaryOutcomeDescription":"Questionnaires",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"Fatigue",
                "SecondaryOutcomeDescription":"Questionnaire",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"Sleeping difficulties",
                "SecondaryOutcomeDescription":"Questionnaires",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"Pain",
                "SecondaryOutcomeDescription":"Questionnaire",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"6. Min walk test",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"Arterial blood gas measures",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"Quality of life",
                "SecondaryOutcomeDescription":"Questionnaire",
                "SecondaryOutcomeTimeFrame":"4 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDyspnoea symptoms in daily life\nSpirometry values showing a COPD moderate stage II (FEV1/FVC<70%, FEV1<80%) and severity grade at a severe stage III (FEV1/FVC<70%, FEV1<50% and FEV1 = 30% of a predicted)\nBe able to read, write and speak Norwegian\nBe at a stable phase of the disease\n\nExclusion Criteria:\n\nChanges in pulmonary medication during the last 4 weeks\nDiagnosis of cancer\nPresently attending a pulmonary rehabilitation course or other similar COPD education courses (due to the fact that these courses often have instructions on breathing control), or having attended similar courses during the last six months\nOngoing exacerbation\nAttending other competitive studies\nDiagnosis of neuromuscular disease\nDiagnosis of dementia\nAttending help from a pulmonary physiotherapist",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"30 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Astrid K Wahl, Professor",
                "OverallOfficialAffiliation":"University of Oslo",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Lovisenberg Diakonale Hospital",
                "LocationCity":"Oslo",
                "LocationZip":"0440",
                "LocationCountry":"Norway"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008173",
                "ConditionMeshTerm":"Lung Diseases, Obstructive"
              },{
                "ConditionMeshId":"D000029424",
                "ConditionMeshTerm":"Pulmonary Disease, Chronic Obstructive"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000008171",
                "ConditionAncestorTerm":"Lung Diseases"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M25724",
                "ConditionBrowseLeafName":"Respiratory Aspiration",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9751",
                "ConditionBrowseLeafName":"Lung Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9753",
                "ConditionBrowseLeafName":"Lung Diseases, Obstructive",
                "ConditionBrowseLeafAsFound":"Obstructive Pulmonary Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M22033",
                "ConditionBrowseLeafName":"Pulmonary Disease, Chronic Obstructive",
                "ConditionBrowseLeafAsFound":"Chronic Obstructive Pulmonary Disease (COPD)",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6174",
                "ConditionBrowseLeafName":"Dyspnea",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T6054",
                "ConditionBrowseLeafName":"Quality of Life",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              }
            ]
          }
        }
      }
    }
  }
}