{"protocolSection":{"identificationModule":{"nctId":"NCT01348542","orgStudyIdInfo":{"id":"35933"},"organization":{"fullName":"Milton S. Hershey Medical Center","class":"OTHER"},"briefTitle":"Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia","officialTitle":"Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration"},"statusModule":{"statusVerifiedDate":"2020-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-06-01","type":"ACTUAL"},"completionDateStruct":{"date":"2018-06-01","type":"ACTUAL"},"studyFirstSubmitDate":"2011-04-20","studyFirstSubmitQcDate":"2011-05-04","studyFirstPostDateStruct":{"date":"2011-05-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-05-28","resultsFirstSubmitQcDate":"2019-05-28","resultsFirstPostDateStruct":{"date":"2019-06-21","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-02-14","lastUpdatePostDateStruct":{"date":"2020-02-25","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Alexandros Vgontzas","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Milton S. Hershey Medical Center"},"leadSponsor":{"name":"Milton S. Hershey Medical Center","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the effect of a 3 month medication trial of Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic insomnia.","detailedDescription":"Participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT, with a 6 month follow up. The primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. The secondary outcome measure will be subjective severity of sleep disturbance."},"conditionsModule":{"conditions":["Insomnia"],"keywords":["Chronic Insomnia","Short Sleep Duration","Trazodone","Cognitive Behavioral Therapy","Efficacy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Trazodone","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Trazodone"]},{"label":"Cognitive Behavioral Therapy","type":"ACTIVE_COMPARATOR","interventionNames":["Behavioral: Cognitive Behavioral Therapy"]}],"interventions":[{"type":"DRUG","name":"Trazodone","description":"50 mg once a day, for 3 months","armGroupLabels":["Trazodone"]},{"type":"BEHAVIORAL","name":"Cognitive Behavioral Therapy","description":"The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.","armGroupLabels":["Cognitive Behavioral Therapy"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)","description":"Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)","timeFrame":"Baseline to Post Treatment (3 months)"},{"measure":"Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)","description":"Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)","timeFrame":"Baseline to follow up (9 months)"},{"measure":"Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)","description":"Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)","timeFrame":"Baseline to Post Treatment (3 months)"},{"measure":"Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)","description":"Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)","timeFrame":"Baseline to follow up (9 months)"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months","description":"The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to post treatment (3 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms.","timeFrame":"Baseline to Post Treatment (3 months)"},{"measure":"Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months","description":"The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to Follow Up (9 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms.","timeFrame":"Baseline to follow up (9 months)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Chronic insomnia with duration of more than 1 year\n* Objective short sleep duration (\\< 6 hours)\n* BMI \\< 39\n* Ages 30-60\n* Men \\& Women\n\nExclusion Criteria:\n\n* Major Mental Illness\n* Substance Abuse/Dependence\n* Sleep Apnea\n* Periodic Limb Movement Disorder\n* Shift Work or circadian disorders\n* Diabetes\n* Chronic Renal Failure, Hepatic Insufficiency, Chronic Heart Failure\n* Current Use of hypnotics or sleep inducing sedative antidepressants","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Alexandros N Vgontzas, MD","affiliation":"Penn State College of Medicine, Penn State Milton S. Hershey Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Penn State College of Medicine, Penn State Milton S. Hershey Medical Center","city":"Hershey","state":"Pennsylvania","zip":"17033","country":"United States","geoPoint":{"lat":40.28592,"lon":-76.65025}}]},"referencesModule":{"references":[{"pmid":"20857861","type":"BACKGROUND","citation":"Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernandez-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64. doi: 10.1093/sleep/33.9.1159."},{"pmid":"19641160","type":"BACKGROUND","citation":"Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Bixler EO. Insomnia with objective short sleep duration is associated with type 2 diabetes: A population-based study. Diabetes Care. 2009 Nov;32(11):1980-5. doi: 10.2337/dc09-0284. Epub 2009 Jul 29."},{"pmid":"19413143","type":"BACKGROUND","citation":"Vgontzas AN, Liao D, Bixler EO, Chrousos GP, Vela-Bueno A. Insomnia with objective short sleep duration is associated with a high risk for hypertension. Sleep. 2009 Apr;32(4):491-7. doi: 10.1093/sleep/32.4.491."},{"pmid":"11502812","type":"BACKGROUND","citation":"Vgontzas AN, Bixler EO, Lin HM, Prolo P, Mastorakos G, Vela-Bueno A, Kales A, Chrousos GP. Chronic insomnia is associated with nyctohemeral activation of the hypothalamic-pituitary-adrenal axis: clinical implications. J Clin Endocrinol Metab. 2001 Aug;86(8):3787-94. doi: 10.1210/jcem.86.8.7778."},{"pmid":"20394314","type":"BACKGROUND","citation":"Fernandez-Mendoza J, Calhoun S, Bixler EO, Pejovic S, Karataraki M, Liao D, Vela-Bueno A, Ramos-Platon MJ, Sauder KA, Vgontzas AN. Insomnia with objective short sleep duration is associated with deficits in neuropsychological performance: a general population study. Sleep. 2010 Apr;33(4):459-65. doi: 10.1093/sleep/33.4.459."},{"pmid":"20978224","type":"BACKGROUND","citation":"Fernandez-Mendoza J, Calhoun SL, Bixler EO, Karataraki M, Liao D, Vela-Bueno A, Jose Ramos-Platon M, Sauder KA, Basta M, Vgontzas AN. Sleep misperception and chronic insomnia in the general population: role of objective sleep duration and psychological profiles. Psychosom Med. 2011 Jan;73(1):88-97. doi: 10.1097/PSY.0b013e3181fe365a. Epub 2010 Oct 26."},{"pmid":"33675113","type":"DERIVED","citation":"Li Y, Vgontzas AN, Fernandez-Mendoza J, Fang J, Puzino K, Bixler EO. Effect of trazodone versus cognitive-behavioural treatment on high- and slow-frequency activity during non-rapid eye movement sleep in chronic insomnia: A pilot, randomized clinical trial. J Sleep Res. 2021 Oct;30(5):e13324. doi: 10.1111/jsr.13324. Epub 2021 Mar 5."},{"pmid":"32780015","type":"DERIVED","citation":"Vgontzas AN, Puzino K, Fernandez-Mendoza J, Krishnamurthy VB, Basta M, Bixler EO. Effects of trazodone versus cognitive behavioral therapy in the insomnia with short sleep duration phenotype: a preliminary study. J Clin Sleep Med. 2020 Dec 15;16(12):2009-2019. doi: 10.5664/jcsm.8740."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months"},{"id":"FG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"11"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months"},{"id":"BG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"21"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"21"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42.6","spread":"8.75"},{"groupId":"BG001","value":"45.27","spread":"9.94"},{"groupId":"BG002","value":"44.0","spread":"9.26"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"19"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","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"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"18"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"21"}]}]}]},{"title":"Insomnia Severity Index","description":"The Insomnia Severity Index (ISI) a self completed questionnaire was used to measure the severity of sleep disturbance. The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI Scale can range from 0-28 with higher total scores indicating a higher severity of insomnia symptoms and sleep disturbance.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16.70","spread":"3.59"},{"groupId":"BG001","value":"16.18","spread":"2.18"},{"groupId":"BG002","value":"16.43","spread":"2.87"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)","description":"Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)","populationDescription":"Objective Short Sleepers defined by 2 week actigraphy sleep duration measurement","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"minutes","timeFrame":"Baseline to Post Treatment (3 months)","groups":[{"id":"OG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months"},{"id":"OG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28.95","spread":"31.70"},{"groupId":"OG001","value":"38.91","spread":"24.74"}]}]}]},{"type":"PRIMARY","title":"Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)","description":"Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)","populationDescription":"From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"minutes","timeFrame":"Baseline to follow up (9 months)","groups":[{"id":"OG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months"},{"id":"OG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.78","spread":"76.39"},{"groupId":"OG001","value":"32.36","spread":"30.31"}]}]}]},{"type":"PRIMARY","title":"Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)","description":"Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)","populationDescription":"From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"minutes","timeFrame":"Baseline to Post Treatment (3 months)","groups":[{"id":"OG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months"},{"id":"OG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.01","spread":"57.50"},{"groupId":"OG001","value":"-11.73","spread":"31.43"}]}]}]},{"type":"PRIMARY","title":"Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)","description":"Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)","populationDescription":"From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"minutes","timeFrame":"Baseline to follow up (9 months)","groups":[{"id":"OG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months"},{"id":"OG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50.35","spread":"27.47"},{"groupId":"OG001","value":"-7.56","spread":"38.04"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months","description":"The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to post treatment (3 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms.","populationDescription":"From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline to Post Treatment (3 months)","groups":[{"id":"OG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months"},{"id":"OG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.29","spread":"4.35"},{"groupId":"OG001","value":"-10.75","spread":"2.87"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months","description":"The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to Follow Up (9 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms.","populationDescription":"From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline to follow up (9 months)","groups":[{"id":"OG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months"},{"id":"OG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.29","spread":"3.77"},{"groupId":"OG001","value":"-10.38","spread":"3.02"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"9 months","eventGroups":[{"id":"EG000","title":"Trazodone","description":"Trazodone: 50 mg once a day, for 3 months","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":0,"otherNumAtRisk":10},{"id":"EG001","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.","deathsNumAffected":0,"deathsNumAtRisk":11,"seriousNumAffected":0,"seriousNumAtRisk":11,"otherNumAffected":0,"otherNumAtRisk":11}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Alexandros Vgontzas","organization":"Penn State University College of Medicine","email":"vgontzas@pennstatehealth.psu.edu","phone":"717 531-7278"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2019-01-03","uploadDate":"2019-05-20T14:23","filename":"Prot_SAP_000.pdf","size":247066}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D007319","term":"Sleep Initiation and Maintenance Disorders"}],"ancestors":[{"id":"D020919","term":"Sleep Disorders, Intrinsic"},{"id":"D020920","term":"Dyssomnias"},{"id":"D012893","term":"Sleep Wake Disorders"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D014196","term":"Trazodone"},{"id":"D015928","term":"Cognitive Behavioral Therapy"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011728","term":"Pyridones"},{"id":"D011725","term":"Pyridines"},{"id":"D001521","term":"Behavior Therapy"},{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"}]}},"hasResults":true}