NCT03708341|UnknownPhase 3DMC
Exogenous Melatonin in Intensive Care Unit Chronodisruption
EMIC
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EMIC
Sponsor study identifier
interventional
98
1 country
1
Study Start
November 15, 2018
Actual (reported)Primary Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To this day, a small number of studies have evaluated the effect of melatonin on the modifications of the characteristics of sleep in critical care units, with mostly a small studied population. However, no study has been realized on a large population, nor has it evaluated the association between genetic factors and response to treatment (melatonin), hence the originality of our study. In our study we hypothesized that systematic melatonin usage in ICU can ameliorate the total sleep time and the fragmentation index and can decrease the confusion related to sleep deprivation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2018
Actual (reported)October 17, 2018
Actual (reported)November 15, 2018
Actual (reported)March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Total sleep time
total time spent sleeping in ICU (in minutes)
14 days or ICU discharge, whichever came first
REM sleep latency
14 days or ICU discharge, whichever came first
Fragmentation index
14 days or ICU discharge, whichever came first
Sleep efficacy
14 days or ICU discharge, whichever came first
Incidence of delirium in ICU
14 days or ICU discharge, whichever came first
Degree of agitation of patients
14 days or ICU discharge, whichever came first
Patients will be administered melatonin 5 mg at a fixed time every day during their ICU stay (from day of admission till day of discharge from ICU)
Patients will be administered a placebo pill that is identical in shape and color to the melatonin pill, at a fixed time every day during their ICU stay
Systematic daily administration of melatonin 5 mg during patient's ICU stay
Hotel Dieu de France
Beirut, Lebanon
Knauert MP, Malik V, Kamdar BB. Sleep and sleep disordered breathing in hospitalized patients. Semin Respir Crit Care Med. 2014 Oct;35(5):582-92. doi: 10.1055/s-0034-1390080. Epub 2014 Oct 29.
Gandhi AV, Mosser EA, Oikonomou G, Prober DA. Melatonin is required for the circadian regulation of sleep. Neuron. 2015 Mar 18;85(6):1193-9. doi: 10.1016/j.neuron.2015.02.016. Epub 2015 Mar 5.
Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15. doi: 10.1164/rccm.2201090.
First Submitted
September 26, 2018
First Posted
October 17, 2018
Study Start
November 15, 2018
Actual (reported)Effect of Topical Melatonin Application on Dental Implant Osseointegration and Marginal Bone Level
Contact the study team to confirm eligibility.
Pisani MA, Friese RS, Gehlbach BK, Schwab RJ, Weinhouse GL, Jones SF. Sleep in the intensive care unit. Am J Respir Crit Care Med. 2015 Apr 1;191(7):731-8. doi: 10.1164/rccm.201411-2099CI.
Jones CR, Huang AL, Ptacek LJ, Fu YH. Genetic basis of human circadian rhythm disorders. Exp Neurol. 2013 May;243:28-33. doi: 10.1016/j.expneurol.2012.07.012. Epub 2012 Jul 28.
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
Huang H, Jiang L, Shen L, Zhang G, Zhu B, Cheng J, Xi X. Impact of oral melatonin on critically ill adult patients with ICU sleep deprivation: study protocol for a randomized controlled trial. Trials. 2014 Aug 18;15:327. doi: 10.1186/1745-6215-15-327.
Primary Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 14, 2024
Record last verified: 2024-02
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