{
  "FullStudy":{
    "Rank":218097,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512771",
          "OrgStudyIdInfo":{
            "OrgStudyId":"00383"
          },
          "Organization":{
            "OrgFullName":"Northport Veterans Affairs Medical Center",
            "OrgClass":"FED"
          },
          "BriefTitle":"The Effect of Nasal Continuous Positive Airway Pressure Treatment on PTSD Symptoms.",
          "OfficialTitle":"The Effect of Nasal Continuous Positive Airway Pressure (Nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.",
          "Acronym":"PTSD"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 23, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 25, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Mohammad M Amin",
            "ResponsiblePartyInvestigatorTitle":"Staff Physician",
            "ResponsiblePartyInvestigatorAffiliation":"Northport Veterans Affairs Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Northport Veterans Affairs Medical Center",
            "LeadSponsorClass":"FED"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"We hypothesize that prevention of Sleep Disordered Breathing among PTSD patients with nasal CPAP will result improve their anxiety, insomnia and alcohol craving (among those who use alcohol to control their symptoms).",
          "DetailedDescription":"Design: This is a pilot study to study the effect of nasal CPAP on the symptoms of PTSD in veterans.\n\nRecruitment Methods:\n\nVeterans with PTSD will be recruited from the Northport VAMC PTSD unit. The ACOS/Mental Health will refer patients that meet inclusion criteria and do not have an impaired decision making capacity. Subjects will be screened for decision-making capacity by their treating psychiatrist as part of their clinical assessment upon admission to the PTSD unit.\n\nStudy Methods\n\nThis will be a prospective, randomized, controlled interventional trial:\n\nParticipants will undergo a routine clinical sleep study at the PTSD unit (using a portable polysomnographic recording unit). or undergo a routine clinical polysomnography to diagnose sleep disordered breathing\n\nParticipants who demonstrate SDB will be randomized into two groups based upon their body mass index\n\nGroup A: BMI < 30 kg/m2\nGroup B: BMI > 30 kg/m2 The reason for these two arms is to study the effect of nasal CPAP upon PTSD symptoms in veterans with a high prevalence of sleep apnea ( BMI above 30 kg/m2) and in veterans with predominantly snoring (BMI below 30 kg/m2).\n\nEach group will then be randomized into two sub-groups regarding treatment.\n\nTreatment group receives an automated CPAP unit to use during sleep for 6 weeks in conjunction with their usual care in the PTSD unit (psychotherapy).\nControl group receives the usual care that is provided in the PTSD unit for 6 weeks (change in medications will exclude the subject from the study), if any participant in the control group would like to try nasal CPAP, then he will be crossed over to use an automated CPAP unit during sleep for his second 6 weeks in the PTSD unit together with usual care.\n\nAll participants will fill out the following questionnaires at baseline and after 6 weeks. (Those in the control group who have been crossed-over to nasal CPAP will also fill out a set of questionnaire at 12 weeks).\n\nPTSD checklist-military version (anxiety)\nMASQ anxious arousal subscale (anxiety)\nInsomnia Severity Index (insomnia)\nThe alcohol craving questionnaire (with an alcohol history during the intake) The changes in patient's reported outcomes will be compared before and after CPAP treatment and psychotherapy alone"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Post Traumatic Stress Disorder",
              "Anxiety",
              "Nightmares",
              "Unrefreshed Sleep"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Crossover"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"18",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"CPAP",
                "InterventionDescription":"6 weeks of CPAP"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.",
                "PrimaryOutcomeDescription":"A comparison of the effectiveness of six weeks of nasal CPAP plus usual care to usual care alone at decreasing the symptoms of PTSD (anxiety, insomnia and alcohol craving) among veterans with PTSD and SDB",
                "PrimaryOutcomeTimeFrame":"six weeks of nasal CPAP"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.",
                "SecondaryOutcomeDescription":"A comparison of the change in symptoms to the change in the total of sleep stage shifts during sleep for all patients with PTSD and SDB participating in the study.",
                "SecondaryOutcomeTimeFrame":"6 weeks of nasal CPAP"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nA. Admitted to PTSD unit at NVAMC and will remain in the unit for at least 12 weeks after initiation of study participation.\n\nB. Found to have SDB by polysomnography\n\nExclusion Criteria:\n\nImpaired Decision-Making Capacity, as determined by treating psychiatrist.\nNo sleep disordered breathing found by polysomnography\nUnable/unwilling to use the nasal CPAP",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"veterans admitted to PTSD unit at Northport VAMC",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Mohammad Amin, MD",
                "OverallOfficialAffiliation":"Northport VAMC",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"PTSD unit at Northport VAMC",
                "LocationCity":"Northport",
                "LocationState":"New York",
                "LocationZip":"11768",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000040921",
                "ConditionMeshTerm":"Stress Disorders, Traumatic"
              },{
                "ConditionMeshId":"D000013313",
                "ConditionMeshTerm":"Stress Disorders, Post-Traumatic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000068099",
                "ConditionAncestorTerm":"Trauma and Stressor Related Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M2905",
                "ConditionBrowseLeafName":"Anxiety Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23503",
                "ConditionBrowseLeafName":"Stress Disorders, Traumatic",
                "ConditionBrowseLeafAsFound":"Traumatic Stress Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14686",
                "ConditionBrowseLeafName":"Stress Disorders, Post-Traumatic",
                "ConditionBrowseLeafAsFound":"Post Traumatic Stress Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M222",
                "ConditionBrowseLeafName":"Trauma and Stressor Related Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}