[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100272634":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":23,"locations":37,"responsibleParty":49,"collaborators":23,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":23,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":23,"enrollmentInfo":59,"targetDuration":23,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":73,"whyStopped":23,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Achros Health Technologies Corporation","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Controlled light, noise and nutrition","EXPERIMENTAL","Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the nutrition protocol corresponding to the daily rhythm will be applied.",[13,14],"Other: Controlled light and noise","Other: Controlled nutrition",{"label":16,"type":10,"description":17,"interventionNames":18},"Controlled light and noise","Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the continuous nutrition (in accordance with the clinical trial site's standard practice) will be applied.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Control","NO_INTERVENTION","The treatment of the study subject will be performed based on the clinical trial site's standard practice without environmental simulation or changes in the nutrition protocol.",null,[25,31],{"type":26,"name":16,"description":27,"armGroupLabels":28,"otherNames":29},"OTHER","Purpose: The day-night ratio of the environmental illumination (limit 8 lux) and that of the noise level (limit 20 dBA) must correspond to the necessary value required by a healthy human body as defined by the National Sleep Foundation (USA).\n\nImplementation: Simulation of the daytime period is performed with blue predominant artificial light with colour temperature between 5500 and 8000 K with lux values of 1000-1200 measured at the head of the patient. Simulation of the nighttime period is performed with a sleeping mask and earplugs.",[16,9],[30],"Environmental simulation of the daytime and night time alternation",{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Controlled nutrition","In compliance with the standard daily nutrition protocol, nutrition is carried out only during daytime both in case of enteral and parenteral feeding in accordance with European Society for Clinical Nutrition and Metabolism 2016 guidelines.\n\nNutritional regimen should be stopped for 8 hours\u002F24 at night (non-nutritional period may be depending on the work schedule of the actual ICU) , even if the daily energy\u002Fprotein target is not reached.",[9],[36],"Nutrition protocol that is in accordance with the daily rhythm",[38],{"facility":39,"status":23,"city":40,"state":23,"zip":23,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":23},"University of Szeged Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy","Szeged","Hungary","HU",{"type":44,"coordinates":45},"Point",[46,47],20.14824,46.253,{"lat":47,"lon":46},{"type":50,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100272634","proof-of-concept-trial-to-confirm-that-the-recovery-of-patients-treated-in-the-intensive-care-unit-requiring-mechanical-ventilation-is-beneficially-affected-by-the-environmental-simulation-of-daytime-and-night-time-alternation-as-well-as-by-the-nutrition-protocol-corresponding-to-the-daily-rhythm-100272634",false,"NCT02828722","Proof of Concept Trial to Confirm That the Recovery of Patients Treated in the Intensive Care Unit Requiring Mechanical Ventilation is Beneficially Affected by the Environmental Simulation of Daytime and Night Time Alternation as Well as by the Nutrition Protocol Corresponding to the Daily Rhythm","Inclusion Criteria:\n\n* Male or female, 18 years or older\n* Requiring treatment at the intensive care unit including mechanical ventilation\n* Admission at the intensive care unit was done within 24 hours before randomization\n* Written and signed patient information sheet and informed consent form obtained by the study participant or by his\u002Fher legal representative\n\nExclusion Criteria:\n\n* Traumatic brain injury\n* Multiple trauma\n* Severe damage of the eye\u002Foptic nerve\n* Blindness\n* Post CPR\n* Unlikely to survive 24 hours\n* Involvement of the central nervous system (trauma, bleeding, infection, ischemia, etc.)\n* Intracranial space occupying process\n* Increased intracranial pressure\n* Narcolepsy\n* Huntington's disease\n* Hypothermia\n* Pregnancy","ALL","18 Years",{"count":60,"type":61},45,"ESTIMATED","INTERVENTIONAL",[64],"NA","The purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU) requiring mechanical ventilation.",[67,68],"Critical Illness","Mechanical Ventilation",[70,67,71,72],"Circadian rhythm","Mechanical ventilation","Environmental modulation","UNKNOWN","2016-07-07",{"date":76,"type":61},"2016-07-12",{"date":78,"type":23},"2016-11",{"date":80,"type":61},"2017-06",{"name":5,"class":6},1]