[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"orthopedic-trauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:orthopedic-trauma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100618796","phase-3-sleep-quality-and-the-efficacy-of-a-multimodal-sleep-pathway-in-hospitalized-orthopedic-trauma-patients-100618796",false,"NCT07336277","Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients","Inclusion Criteria:\n\n* Hospitalized with an isolated lower extremity orthopedic injury requiring surgical intervention.\n* Expected hospital stay of at least 3 days.\n* No known pre-existing sleep disorders.\n* No current use of sleep aids, such as zolpidem or melatonin, before hospitalization\n\nExclusion Criteria:\n\n* Participants with a history of chronic opioid use prior to hospitalization.\n* Pre-existing diagnosed sleep disorders (e.g., obstructive sleep apnea, insomnia).\n* Contraindications to zolpidem or melatonin use (e.g., allergies, interactions with other medications).\n* Cognitive impairment or inability to comply with study procedures.\n* Severe traumatic brain injury or other neurological conditions that may affect sleep or pain perception.\n* Participants receiving mechanical ventilation or sedatives that significantly affect sleep architecture.","ALL","18 Years","65 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The goal of this study is to determine whether a multimodal sleep pathway can enhance sleep quality in hospitalized patients with orthopedic trauma. It will also evaluate the effect of this pathway on opioid use and pain perception during recovery.\n\nThe main study questions are:\n\n* Does the multimodal sleep pathway improve sleep quality and duration?\n* Does the pathway reduce the amount of opioids patients use during hospitalization?\n* Does improved sleep reduce pain interference with daily activities?\n\nResearchers will compare the multimodal sleep pathway to standard postoperative care to see if the pathway helps patients sleep better and rely less on opioids.\n\nParticipants will:\n\n* Receive either the multimodal sleep pathway (zolpidem, melatonin, and sleep hygiene education) or standard care\n* Wear a wrist-worn actigraphy device to track sleep during their hospital stay\n* Complete daily questionnaires about sleep quality and pain",[26,27],"Orthopedic Trauma","Sleep Quality",[29,27,30],"Multimodal Sleep Pathway","Opioid consumption","NOT_YET_RECRUITING","2026-05-05",{"date":34,"type":35},"2026-05-08","ACTUAL",{"date":37,"type":20},"2026-06",{"date":39,"type":20},"2026-07",{"name":41,"class":42},"Emory University","OTHER"]