Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
975 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-01-01
Study Completion Date
2022-12-31
Brief Summary
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This study evaluates the quality of sleep of patients admitted to medical and intensive care units. All of them will have a clock placed to measure their circadian activity. Also, data will be recorded through questionnaires about the unit, patient habits and medical problems.
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Detailed Description
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The investigators found an extensive bibliography related to the quality of sleep and its effects on health. However, it should be noted the literary emptiness in relation to the influential factors in it. Chronobiology is the science responsible for studying the rhythmic changes in living beings; where the investigators include the circadian rhythm. In this way, all the "cycles" will be influenced by a series of factors that allow its correct operation, being in this case the light-dark cycle (LD), together with the temperature compensation, these being the determinants that allow, or not homeostasis.
The sleep - wake pattern is one of the most important circadian rhythms that happen in the organism. The dream is an unconscious process by which, despite the muscular relaxation that occurs, it is accompanied by continuous brain activity along with sensitive perception, where several of the organ systems come into play. This cycle is composed of two factors: a homeostatic one directly proportional to the time we are awake, and another circadian, dependent on the secretion of melatonin and the body's regulation of temperature. This fact can be compromised by the appearance of both external and internal stimuli, altering normal functioning, which is translated into sleep deprivation, which, if extended over time, can have physical and mental consequences, Some of them are: deterioration of the immune function, an increase in the incidence of cardiovascular diseases, memory deficit, early aging, mood swings, difficulty in healing, greater probability of developing metabolic syndromes, cognitive, affective disorders and even some types of cancer
The results obtained will facilitate the elaboration of action protocols focused on improving sleep quality in hospitalized patients.
The sleep - wake pattern is one of the most important circadian rhythms that happen in the organism. The dream is an unconscious process by which, despite the muscular relaxation that occurs, it is accompanied by continuous brain activity along with sensitive perception, where several of the organ systems come into play. This cycle is composed of two factors: a homeostatic one directly proportional to the time we are awake, and another circadian, dependent on the secretion of melatonin and the body's regulation of temperature. This fact can be compromised by the appearance of both external and internal stimuli, altering normal functioning, which is translated into sleep deprivation, which, if extended over time, can have physical and mental consequences, Some of them are: deterioration of the immune function, an increase in the incidence of cardiovascular diseases, memory deficit, early aging, mood swings, difficulty in healing, greater probability of developing metabolic syndromes, cognitive, affective disorders and even some types of cancer
The results obtained will facilitate the elaboration of action protocols focused on improving sleep quality in hospitalized patients.
Conditions
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Chronobiology Disorders
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* subjects over 18 years of age, minimum duration of the hospitalization process of 96h, conscious and oriented with constancy in their clinical history (HC) and who give their consent.
Exclusion Criteria
* personas con discapacidad visual y/o auditiva documentada en su HC, en el caso de los pacientes de Unidades de Cuidados Intensivos (UCIs) se excluirán a aquellos que obtengan una puntuación inferior a 8 en la escala Glasgow. Pacientes con cualquier tipo de aislamiento y aquellos incluidos en el plan de Cuidados Paliativos.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Institut de Recerca Biomèdica de Lleida
OTHER
Sponsor Role
collaborator
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
OTHER
Sponsor Role
collaborator
Instituto de Salud Carlos III
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Teresa Moreno Casbas
Doctor, Clinical Research
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Teresa Moreno Casbas
Madrid, , Spain
Site Status
Countries
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Spain
References
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Erren TC, Reiter RJ. Revisiting chronodisruption: when the physiological nexus between internal and external times splits in humans. Naturwissenschaften. 2013 Apr;100(4):291-8. doi: 10.1007/s00114-013-1026-5. Epub 2013 Mar 14.
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RESULT
Erren TC, Reiter RJ. Defining chronodisruption. J Pineal Res. 2009 Apr;46(3):245-7. doi: 10.1111/j.1600-079X.2009.00665.x. Epub 2009 Feb 9.
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RESULT
Garaulet M, Madrid JA. Chronobiological aspects of nutrition, metabolic syndrome and obesity. Adv Drug Deliv Rev. 2010 Jul 31;62(9-10):967-78. doi: 10.1016/j.addr.2010.05.005. Epub 2010 May 24.
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RESULT
Saper CB, Scammell TE, Lu J. Hypothalamic regulation of sleep and circadian rhythms. Nature. 2005 Oct 27;437(7063):1257-63. doi: 10.1038/nature04284.
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RESULT
Tononi G, Cirelli C. Sleep function and synaptic homeostasis. Sleep Med Rev. 2006 Feb;10(1):49-62. doi: 10.1016/j.smrv.2005.05.002. Epub 2005 Dec 22.
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RESULT
Martínez Nicolás AB, Blázquez Manzanera A. La hora de nuestro cuerpo. Monitorización Ambulatoria Circadiana. Revista Eubacteria 2015; 33: 22-28.
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RESULT
8 National Institute of Neurological Disorders and Stroke. (2007). How much sleep do we need? In Brain Basics: Understanding Sleep. [obtenido de: http://bit.ly/2rA34Zk consultado 30 de enero de 2018].
Reference Type
RESULT
da Costa SV, Ceolim MF. [Factors that affect inpatients' quality of sleep]. Rev Esc Enferm USP. 2013 Feb;47(1):46-52. doi: 10.1590/s0080-62342013000100006. Portuguese.
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RESULT
Hacker ED, Kapella MC, Park C, Ferrans CE, Larson JL. Sleep Patterns During Hospitalization Following Hematopoietic Stem Cell Transplantation. Oncol Nurs Forum. 2015 Jul;42(4):371-9. doi: 10.1188/15.ONF.371-379.
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Van Someren EJ, Cirelli C, Dijk DJ, Van Cauter E, Schwartz S, Chee MW. Disrupted Sleep: From Molecules to Cognition. J Neurosci. 2015 Oct 14;35(41):13889-95. doi: 10.1523/JNEUROSCI.2592-15.2015.
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RESULT
Cho K, Ennaceur A, Cole JC, Suh CK. Chronic jet lag produces cognitive deficits. J Neurosci. 2000 Mar 15;20(6):RC66. doi: 10.1523/JNEUROSCI.20-06-j0005.2000.
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RESULT
Pandi-Perumal SR, Moscovitch A, Srinivasan V, Spence DW, Cardinali DP, Brown GM. Bidirectional communication between sleep and circadian rhythms and its implications for depression: lessons from agomelatine. Prog Neurobiol. 2009 Aug;88(4):264-71. doi: 10.1016/j.pneurobio.2009.04.007. Epub 2009 May 18.
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RESULT
Davis S, Mirick DK, Stevens RG. Night shift work, light at night, and risk of breast cancer. J Natl Cancer Inst. 2001 Oct 17;93(20):1557-62. doi: 10.1093/jnci/93.20.1557.
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RESULT
Kondratov RV. A role of the circadian system and circadian proteins in aging. Ageing Res Rev. 2007 May;6(1):12-27. doi: 10.1016/j.arr.2007.02.003. Epub 2007 Feb 21.
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RESULT
Venkateshiah SB, Collop NA. Sleep and sleep disorders in the hospital. Chest. 2012 May;141(5):1337-1345. doi: 10.1378/chest.11-2591.
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RESULT
Young JS, Bourgeois JA, Hilty DM, Hardin KA. Sleep in hospitalized medical patients, part 1: factors affecting sleep. J Hosp Med. 2008 Nov-Dec;3(6):473-82. doi: 10.1002/jhm.372.
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RESULT
Erren TC, Reiter RJ. Preventing cancers caused by chronodisruption: blocking blue light alone is unlikely to do the trick. Med Hypotheses. 2009 Dec;73(6):1077-8. doi: 10.1016/j.mehy.2009.05.003. Epub 2009 Jun 3. No abstract available.
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RESULT
Portas CM, Krakow K, Allen P, Josephs O, Armony JL, Frith CD. Auditory processing across the sleep-wake cycle: simultaneous EEG and fMRI monitoring in humans. Neuron. 2000 Dec;28(3):991-9. doi: 10.1016/s0896-6273(00)00169-0.
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RESULT
Halperin D. Environmental noise and sleep disturbances: A threat to health? Sleep Sci. 2014 Dec;7(4):209-12. doi: 10.1016/j.slsci.2014.11.003. Epub 2014 Nov 15.
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RESULT
Delaney LJ, Van Haren F, Lopez V. Sleeping on a problem: the impact of sleep disturbance on intensive care patients - a clinical review. Ann Intensive Care. 2015 Feb 26;5:3. doi: 10.1186/s13613-015-0043-2. eCollection 2015.
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RESULT
Little A, Ethier C, Ayas N, Thanachayanont T, Jiang D, Mehta S. A patient survey of sleep quality in the Intensive Care Unit. Minerva Anestesiol. 2012 Apr;78(4):406-14. Epub 2012 Feb 15.
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RESULT
Carvalho Bos S, Waterhouse J, Edwards B, Simons R, Reilly T. The use of actimetry to assess changes to the rest-activity cycle. Chronobiol Int. 2003 Nov;20(6):1039-59. doi: 10.1081/cbi-120025397.
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Roenneberg T, Kuehnle T, Juda M, Kantermann T, Allebrandt K, Gordijn M, Merrow M. Epidemiology of the human circadian clock. Sleep Med Rev. 2007 Dec;11(6):429-38. doi: 10.1016/j.smrv.2007.07.005. Epub 2007 Nov 1.
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RESULT
Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. doi: 10.1093/sleep/26.3.342.
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RESULT
Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
Reference Type
RESULT
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
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Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
Reference Type
RESULT
Other Identifiers
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PI18/2019-v3
Identifier Type: -
Identifier Source: org_study_id
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