{"protocolSection":{"identificationModule":{"nctId":"NCT02458469","orgStudyIdInfo":{"id":"NURC-062-12S"},"secondaryIdInfos":[{"id":"1IK2CX000547","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1IK2CX000547"}],"organization":{"fullName":"VA Office of Research and Development","class":"FED"},"briefTitle":"Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI","officialTitle":"Pathogenesis of Sleep Disordered Breathing in Spinal Cord Injury Patients","acronym":"REST-SCI"},"statusModule":{"statusVerifiedDate":"2021-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-05-14","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-04-12","type":"ACTUAL"},"completionDateStruct":{"date":"2019-04-12","type":"ACTUAL"},"studyFirstSubmitDate":"2015-05-21","studyFirstSubmitQcDate":"2015-05-27","studyFirstPostDateStruct":{"date":"2015-06-01","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-03-26","resultsFirstSubmitQcDate":"2020-03-26","resultsFirstPostDateStruct":{"date":"2020-04-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-06-11","lastUpdatePostDateStruct":{"date":"2021-06-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"VA Office of Research and Development","class":"FED"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The purpose of this study is to look at the effect of exciting using drugs 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) during sleep. During this part of the study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of time followed by two weeks without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for two weeks followed by a night study to look at the effect the medication/placebo pill has on the way the body responds during sleep.","detailedDescription":"Randomized placebo controlled cross-over study. Each subject will be studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; the patients will be blinded to whether they are taking trazodone or placebo; buspirone cannot be blinded because it is dosed twice a day and is up titrated during the two weeks of administration. The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached. After the two week treatment a sleep study will be repeated. Trazodone will be given at 100 mg dose before bed-time. (2) Cross over medication for two weeks will be followed by a second sleep study followed by two weeks washout. (3) Cross over medication for two weeks will be followed by another sleep study. To assess the clinical effect of the drug on breathing during sleep a qualitative polysomnography will be performed for 2 hours the same night after taking the drug/placebo. This will allow the determination of ventilatory changes and the determination of the number of respiratory events (apnea/hypopnea index)."},"conditionsModule":{"conditions":["Spinal Cord Injury","Sleep Disordered Breathing"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":15,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Buspirone","type":"ACTIVE_COMPARATOR","description":"This drug will be taken for two week period","interventionNames":["Drug: Buspirone"]},{"label":"Trazodone","type":"ACTIVE_COMPARATOR","description":"This drug will be taken for two week period","interventionNames":["Drug: Trazodone"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"A placebo pill will be taken at bed time for two week period","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Buspirone","description":"The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.","armGroupLabels":["Buspirone"]},{"type":"DRUG","name":"Trazodone","description":"100 mg dose before bed-time","armGroupLabels":["Trazodone"]},{"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 three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a noninvasive nasal mechanical ventilation study was repeated to determine the hypocapnic apneic threshold. (2) Cross over medication for two weeks was followed by a second noninvasive nasal mechanical ventilation study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the hypocapnic apneic threshold.","timeFrame":"Two weeks"}],"secondaryOutcomes":[{"measure":"Apnea-Hypopnea Index (AHI)","description":"Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a polysomnogram (PSG) study was repeated to determine the AHI. (2) Cross over medication for two weeks was followed by a second PSG to determine the AHI followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the AHI.","timeFrame":"Two weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adults with SCI (\\>6months after spinal cord injury) at the T6 level/above\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\n* The following medications are not allowed (potential interaction with buspirone or inhibition of the CYP3A4 system):\n\n  * cimetidine\n  * ketoconazole\n  * ritonavir\n  * itraconazole\n  * erythromycin\n  * diltiazem\n  * verapamil\n  * Monoamine oxidase (MAO) inhibitors \\[such as Marplan, Nardil, Parmate, Emsam\\]\n  * Other prohibited concomitant medications include haloperidol, trazodone, or triazolam","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Abdulghani Sankari, MD PhD","affiliation":"John D. Dingell VA Medical Center, Detroit, MI","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"John D. Dingell VA Medical Center, Detroit, MI","city":"Detroit","state":"Michigan","zip":"48201","country":"United States","geoPoint":{"lat":42.33143,"lon":-83.04575}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Of 150 available, 15 participants were enrolled. Of the 15 enrolled, 11 started the study protocol.","recruitmentDetails":"Participants were recruited to the primary site at John D. Dingell VA Medical Center.","groups":[{"id":"FG000","title":"Placebo->Buspirone->Trazodone","description":"Participants first received a placebo taken once daily for two weeks. After a washout period of two weeks, the participants then received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After another washout period of two weeks, participants received trazodone (100 mg) once daily for two weeks."},{"id":"FG001","title":"Placebo->Trazodone->Buspirone","description":"Participants first received a placebo taken once daily for two weeks. After a washout period of two weeks, the participants then received trazodone (100 mg) once daily for two weeks. After another washout period of two weeks, participants received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks."},{"id":"FG002","title":"Buspirone->Trazodone->Placebo","description":"Participants first received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After a washout period of two weeks, the participants then received trazodone (100 mg) once daily for two weeks. After another washout period of two weeks, participants received a placebo taken once daily for two weeks."},{"id":"FG003","title":"Buspirone->Placebo->Trazodone","description":"Participants first received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After a washout period of two weeks, the participants then received a placebo taken once daily for two weeks. After another washout period of two weeks, participants received trazodone (100 mg) once daily for two weeks."},{"id":"FG004","title":"Trazodone->Placebo->Buspirone","description":"Participants first received trazodone (100 mg) once daily for two weeks. After a washout period of two weeks, the participants then received a placebo taken once daily for two weeks. After another washout period of two weeks, participants received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks."},{"id":"FG005","title":"Trazodone->Buspirone->Placebo","description":"Participants first received trazodone (100 mg) once daily for two weeks. After a washout period of two weeks, the participants then received buspirone taken twice daily (7.5 - 15 mg) on an increasing scale for two weeks. After another washout period of two weeks, participants received a placebo taken once daily for two weeks."}],"periods":[{"title":"First Intervention (2 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}]},{"title":"First Washout (2 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}]},{"title":"Second Intervention (2 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}]}]},{"title":"Second Washout (2 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}]},{"title":"Third Intervention (2 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"All Study Participants","description":"Participants who were randomized to receive either Buspirone (7.5-15 mg) or Trazodone (100 mg) or Placebo tablet"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.2","spread":"13.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"}]}]}]},{"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":"10"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"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":"5"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"11"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"CO2 Reserve (Delta-PETCO2-AT)","description":"Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a noninvasive nasal mechanical ventilation study was repeated to determine the hypocapnic apneic threshold. (2) Cross over medication for two weeks was followed by a second noninvasive nasal mechanical ventilation study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the hypocapnic apneic threshold.","populationDescription":"Only 8 of the 15 enrolled participants finished all three medication arms (placebo, buspirone, trazodone) and were used in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Two weeks","groups":[{"id":"OG000","title":"Buspirone","description":"This drug will be taken for two week period\n\nBuspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached."},{"id":"OG001","title":"Trazodone","description":"This drug will be taken for two week period\n\nTrazodone: 100 mg dose before bed-time"},{"id":"OG002","title":"Placebo","description":"A placebo pill will be taken at bed time for two week period\n\nPlacebo: One placebo pill before bed-time"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.6","spread":"0.9"},{"groupId":"OG001","value":"-2.5","spread":"1.0"},{"groupId":"OG002","value":"-1.8","spread":"1.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.019","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.015","statisticalMethod":"Student-Newman-Keuls Method"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.231","statisticalMethod":"Student-Newman-Keuls Method"}]},{"type":"SECONDARY","title":"Apnea-Hypopnea Index (AHI)","description":"Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a polysomnogram (PSG) study was repeated to determine the AHI. (2) Cross over medication for two weeks was followed by a second PSG to determine the AHI followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the AHI.","populationDescription":"Only 8 of the 15 enrolled participants finished all three medication arms (placebo, buspirone, trazodone) and were used in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Events/Hour","timeFrame":"Two weeks","groups":[{"id":"OG000","title":"Buspirone","description":"This drug will be taken for two week period\n\nBuspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached."},{"id":"OG001","title":"Trazodone","description":"This drug will be taken for two week period\n\nTrazodone: 100 mg dose before bed-time"},{"id":"OG002","title":"Placebo","description":"A placebo pill will be taken at bed time for two week period\n\nPlacebo: One placebo pill before bed-time"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"48.7","spread":"21.4"},{"groupId":"OG001","value":"40.0","spread":"23.9"},{"groupId":"OG002","value":"45.2","spread":"23.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.749","statisticalMethod":"ANOVA"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Adverse event data were collected during the two-week interventions during which the participants were taking Buspirone, Trazodone, or placebo.","description":"Of the 11 participants who started the study protocol, 10 received Buspirone, 9 received Trazodone, and 9 received a placebo due to participant withdrawal and physician removal.","eventGroups":[{"id":"EG000","title":"Buspirone","description":"This drug will be taken for two week period\n\nBuspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":3,"otherNumAtRisk":10},{"id":"EG001","title":"Trazodone","description":"This drug will be taken for two week period\n\nTrazodone: 100 mg dose before bed-time","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":0,"otherNumAtRisk":9},{"id":"EG002","title":"Placebo","description":"A placebo pill will be taken at bed time for two week period\n\nPlacebo: One placebo pill before bed-time","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":1,"seriousNumAtRisk":9,"otherNumAffected":0,"otherNumAtRisk":9}],"seriousEvents":[{"term":"Suicidal Thoughts","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":9}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9}]},{"term":"Fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":9},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":9}]}]},"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_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2020-03-12","uploadDate":"2020-03-12T09:24","filename":"Prot_SAP_000.pdf","size":188468}]}},"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":"D002065","term":"Buspirone"},{"id":"D014196","term":"Trazodone"}],"ancestors":[{"id":"D013141","term":"Spiro Compounds"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011743","term":"Pyrimidines"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D011728","term":"Pyridones"},{"id":"D011725","term":"Pyridines"}]}},"hasResults":true}