[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644647":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":18,"responsibleParty":30,"collaborators":18,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":18,"enrollmentInfo":42,"targetDuration":18,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":52,"overallStatus":59,"whyStopped":18,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":18},{"fullName":5,"class":6},"Fundación de investigación HM","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Multimodal Sleep Promotion Intervention","EXPERIMENTAL","Participants admitted to the intervention ICU will receive a multimodal sleep promotion program consisting of individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and optimization of nursing care activities to minimize unnecessary sleep interruptions during the ICU stay.",[13],"Behavioral: Multimodal Sleep Promotion Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual ICU Care","NO_INTERVENTION","Participants admitted to the control ICU will receive usual intensive care unit care without implementation of the structured multimodal sleep promotion program. Any sleep-related measures provided as part of routine clinical practice will be documented.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","The multimodal sleep promotion intervention consists of four components: (1) individualized sleep hygiene education, including information on sleep physiology, the importance of minimizing nighttime disturbances, and strategies to improve sleep during ICU stay; (2) provision and encouragement of nighttime use of earplugs and an eye mask; (3) environmental modifications aimed at reducing noise, light exposure, and thermal discomfort during the night; and (4) optimization of nursing care activities by clustering non-urgent procedures and minimizing avoidable nighttime interruptions. The intervention is delivered throughout the ICU stay according to a structured sleep promotion protocol.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Cayetana Ruiz Zaldibar","CONTACT","695829472","crzaldibar@ucjc.edu",{"type":31,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100644647","multimodal-sleep-promotion-in-surgical-icu-patients-100644647",false,"NCT07672509","Multimodal Sleep Promotion in Surgical ICU Patients","Multimodal Sleep Promotion Intervention in Adult Postoperative Intensive Care Unit Patients: Two-Center Non-Randomized Controlled Pilot Study","MULTISLEEP","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Patients admitted to an adult intensive care unit after surgery.\n* Expected ICU stay of at least one night.\n* Patients with clinical stability and adequate pain control allowing participation in the intervention and completion of study assessments.\n* Patients able to understand and complete the questionnaires, either independently or with minimal assistance.\n* Patients without language barriers that prevent study participation.\n\nExclusion Criteria:\n\n* Patients with acute neurological impairment or moderate to severe cognitive dysfunction.\n* Patients receiving invasive mechanical ventilation with ongoing sedation.\n* Patients with a severe pre-existing sleep disorder requiring specific treatment not available in the ICU setting.\n* Patients unable to provide questionnaire responses due to communication limitations or clinical condition.\n* Patients with language barriers preventing participation in study procedures and completion of study assessments","ALL","18 Years",{"count":43,"type":44},50,"ESTIMATED","INTERVENTIONAL",[47],"NA","Sleep disturbances are highly prevalent among patients admitted to intensive care units (ICUs). Critical illness, environmental factors, and routine clinical care frequently result in fragmented sleep, reduced sleep quality, and disruption of normal circadian rhythms. Previous studies have shown that poor sleep in ICU patients may be associated with delirium, impaired recovery, decreased functional outcomes, and lower patient satisfaction.\n\nEnvironmental factors such as noise generated by alarms and medical equipment, continuous light exposure, frequent nursing interventions, pain, anxiety, and discomfort related to invasive devices have been identified as major contributors to sleep disruption in critically ill patients. Several non-pharmacological interventions, including earplugs, eye masks, environmental modifications, and nursing care bundles, have demonstrated potential benefits in improving sleep quality. However, most studies have focused on isolated interventions, and evidence regarding comprehensive multimodal approaches remains limited.\n\nThis two-center non-randomized controlled pilot study aims to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and reorganization of nursing care activities to minimize unnecessary sleep interruptions. Patients admitted to the intervention ICU will receive the multimodal sleep promotion program, while patients admitted to the control ICU will receive usual care.\n\nThe primary objective is to assess the effect of the intervention on patient-reported sleep quality. Secondary objectives include evaluating patient experience during ICU stay and exploring the relationship between sleep outcomes and selected demographic and clinical variables. The findings of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of multimodal sleep promotion strategies in adult ICU settings and may support the development of future larger-scale studies.",[50,51],"Sleep Wake Disorders","Critical Illness",[53,54,55,56,57,58],"Sleep Quality","ICU Patients","Sleep Promotion","Sleep Hygiene","Patient Experience","Humanization of Care","NOT_YET_RECRUITING","2026-06-26",{"date":62,"type":63},"2026-06-29","ACTUAL",{"date":65,"type":44},"2026-07-01",{"date":67,"type":44},"2026-11-30",{"name":5,"class":6}]