{"protocolSection":{"identificationModule":{"nctId":"NCT04799782","orgStudyIdInfo":{"id":"100712M1F(V)"},"organization":{"fullName":"Wayne State University","class":"OTHER"},"briefTitle":"Role of Mirtazapine in Ameliorating Sleep Disordered Breathing","officialTitle":"Role of Mirtazapine in Ameliorating Sleep Disordered Breathing"},"statusModule":{"statusVerifiedDate":"2021-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-05-18","type":"ACTUAL"},"completionDateStruct":{"date":"2019-05-18","type":"ACTUAL"},"studyFirstSubmitDate":"2021-03-11","studyFirstSubmitQcDate":"2021-03-11","studyFirstPostDateStruct":{"date":"2021-03-16","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-03-18","resultsFirstSubmitQcDate":"2021-04-14","resultsFirstPostDateStruct":{"date":"2021-04-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-05-21","lastUpdatePostDateStruct":{"date":"2021-06-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Dr. Abdulghani Sankari, MD PhD","investigatorTitle":"Professor, Clinical Educator, Pulmonary/Critical Care Fellowship Program Director","investigatorAffiliation":"Wayne State University"},"leadSponsor":{"name":"Wayne State University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The purpose of this study is to look at the effect of using Mirtazapine to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) and non-injured persons during sleep. During this part of the study participants will be asked to take Mirtazapine (15mg per day) and a placebo in a random fashion, each for a one week period (drug period) of time followed by one week without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for one weeks followed by a night study to look at the effect the Mirtazapine/placebo pill has on the way the body responds during sleep.","detailedDescription":"Randomized placebo controlled cross-over study. Each subject will be studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; the participants will be blinded to whether they are taking Mirtazapine or placebo. After the one week treatment a sleep study will be repeated. Mirtazapine will be given at 15 mg dose before bed-time. (2) Cross over medication for one week will be followed by a second sleep study."},"conditionsModule":{"conditions":["Spinal Cord Injuries","Sleep Disordered Breathing"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"OTHER","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":18,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Mirtazapine","type":"ACTIVE_COMPARATOR","description":"The drug will be taken for a one week peroid.","interventionNames":["Drug: Mirtazapine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"The drug will be taken for a one week peroid.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Mirtazapine","description":"15 mg dose before bed-time","armGroupLabels":["Mirtazapine"]},{"type":"DRUG","name":"Placebo","description":"One placebo pill before bed-time","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"CO2 Reserve (Delta-PETCO2-AT)","description":"Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a physiological sleep study was performed to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. (2) Cross over medication for one week was followed by a second physiological sleep study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold.","timeFrame":"One Week"}],"secondaryOutcomes":[{"measure":"AHI (Apnea/Hypopnea Index)","description":"AHI is an index that measures the severity of sleep apnea and is calculated by dividing the total number of apneas and hypopneas by the number of hours of sleep. Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a polysomnogram (PSG) study was performed to determine the AHI. (2) Cross over medication for one week was followed by a second PSG to determine the AHI.","timeFrame":"One Week"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adults with SCI (\\>6months after spinal cord injury) at the T6 level/above\n* Non-injured adults\n\nExclusion Criteria:\n\n* Pregnant and lactating females\n* Heart failure, vascular disease, or stroke\n* Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease\n* BMI \\>38 kg/m2\n* Mechanical ventilation dependence","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Of 150 available, 18 participants were enrolled. Of the 18 enrolled, 15 started the study protocol. Of the 15 that started the study protocol, 10 completed the study and had their results analyzed.","recruitmentDetails":"Participants were recruited to the primary site at John D. Dingell VA Medical Center.","groups":[{"id":"FG000","title":"Placebo->Mirtazapine","description":"Participants first received a placebo taken once daily for one week. After a washout period of one week, the participants then received mirtazapine taken once daily (15 mg) for one week."},{"id":"FG001","title":"Mirtazapine->Placebo","description":"Participants first received mirtazapine taken once daily (15 mg) for one week. After a washout period of one week, the participants then received a placebo taken once daily for one week."}],"periods":[{"title":"First Intervention","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Washout","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]},{"title":"Second Intervention","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"All Study Participants","description":"Participants who were randomized to receive either Mirtazapine (15 mg) or Placebo tablet"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"15"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.5","spread":"12.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"15"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"13"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"2"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"8"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"CO2 Reserve (Delta-PETCO2-AT)","description":"Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a physiological sleep study was performed to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. (2) Cross over medication for one week was followed by a second physiological sleep study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold.","populationDescription":"Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"One Week","groups":[{"id":"OG000","title":"Mirtazapine","description":"The drug will be taken for a one week peroid.\n\nMirtazapine: 15 mg dose before bed-time"},{"id":"OG001","title":"Placebo","description":"The drug will be taken for a one week peroid.\n\nPlacebo: One placebo pill before bed-time"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.8","spread":"1.2"},{"groupId":"OG001","value":"-2.0","spread":"1.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.015","statisticalMethod":"t-test, 2 sided"}]},{"type":"SECONDARY","title":"AHI (Apnea/Hypopnea Index)","description":"AHI is an index that measures the severity of sleep apnea and is calculated by dividing the total number of apneas and hypopneas by the number of hours of sleep. Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a polysomnogram (PSG) study was performed to determine the AHI. (2) Cross over medication for one week was followed by a second PSG to determine the AHI.","populationDescription":"Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Events/Hour","timeFrame":"One Week","groups":[{"id":"OG000","title":"Mirtazapine","description":"The drug will be taken for a one week peroid.\n\nMirtazapine: 15 mg dose before bed-time"},{"id":"OG001","title":"Placebo","description":"The drug will be taken for a one week peroid.\n\nPlacebo: One placebo pill before bed-time"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"46.4","spread":"22.5"},{"groupId":"OG001","value":"47.8","spread":"20.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.82","statisticalMethod":"t-test, 2 sided"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse event data were collected during the one-week interventions during which the participants were taking Mirtazapine or placebo","description":"Of the 15 participants who started the study protocol, 13 received Mirtazapine and 12 received a placebo due to participant withdrawal and physician removal.","eventGroups":[{"id":"EG000","title":"Mirtazapine","description":"The drug will be taken for a one week peroid.\n\nMirtazapine: 15 mg dose before bed-time","deathsNumAffected":0,"deathsNumAtRisk":13,"seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":1,"otherNumAtRisk":13},{"id":"EG001","title":"Placebo","description":"The drug will be taken for a one week peroid.\n\nPlacebo: One placebo pill before bed-time","deathsNumAffected":0,"deathsNumAtRisk":12,"seriousNumAffected":1,"seriousNumAtRisk":12,"otherNumAffected":0,"otherNumAtRisk":12}],"seriousEvents":[{"term":"Suicidal Thoughts","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":13},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":12}]}],"otherEvents":[{"term":"Muscle Weakness","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":13},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"* The sample size is small and the majority are males, therefore findings from this study may not be applicable to the general population\n* The study required heavy instrumentation which may have affected natural sleep"},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Abdulghani Sankari Principal Investigator","organization":"JOHN D DINGELL VA MEDICAL CENTER","email":"abdulghani.sankari@va.gov","phone":"13135761000","phoneExt":"63105"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2021-04-14","uploadDate":"2021-04-14T10:27","filename":"Prot_000.pdf","size":500895},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2021-04-14","uploadDate":"2021-04-14T10:28","filename":"SAP_001.pdf","size":497415}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D013119","term":"Spinal Cord Injuries"},{"id":"D012891","term":"Sleep Apnea Syndromes"}],"ancestors":[{"id":"D013118","term":"Spinal Cord Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D020196","term":"Trauma, Nervous System"},{"id":"D014947","term":"Wounds and Injuries"},{"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"}]},"interventionBrowseModule":{"meshes":[{"id":"D000078785","term":"Mirtazapine"}],"ancestors":[{"id":"D003984","term":"Dibenzazepines"},{"id":"D006575","term":"Heterocyclic Compounds, 3-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}