An observational study in Chronobiology Disorders, sponsored by Instituto de Salud Carlos III. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Instituto de Salud Carlos III · Observational
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.
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.
102 studies on the registry are indexed under Chronobiology Disorders; 22 are open to participants now.
This study's enrollment of 975 is above the median of 80 across 33 observational studies indexed under Chronobiology Disorders.
Browse Chronobiology Disorders studies →Instituto de Salud Carlos III is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Users who are part of the study must be adults admitted to intensive care units (ICUs), Medical Units (UMs) and Surgical units (UQs), of the 13 participating hospitals: Andalusia (H. Juan Ramón Jiménez, Huelva), Catalonia (H. Mataró and H. Arnau Villanova, Lleida), Cantabria (HU Marqués Valdecilla), Castilla y León (H. del Bierzo, Ponferrada), Castila-La Mancha (HGU Ciudad Real), C. Madrid (HU 12 de Octubre ), C. Valenciana (HGU Valencia and HGU Alicante), Murcia Region (C H Cartagena, HCU V Arrixaca) and Basque Country (H. Basurto, Bilbao and H. Galdakao-Usansolo, Vizcaya).
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Exclusion Criteria:
Circadian Health
Using the KRONOHEALTH® recording device, we will measure the following indicators: * Total Sleep Time * Sleep Fragmentations * Sleep depth * Chronobiological health index
Time frame: 96 hours
Subjective Sleep Quality
Scores in the Pittsburgh sleep quality index
Time frame: 1 day (one time evaluation)
Degree of sleep interference during hospitalization
Visual analogue scale from 0 to 10 points.
Time frame: 1 day (one time evaluation)
Plan to share: No
Ran from Jan 2019 to primary completion in Dec 2022, 47 months.
Of 19 observational studies under Chronobiology Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's 47 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Instituto de Salud Carlos III