Circadian Health and Influential Factors

Chronobiology Disorders Clinical Trial

— CHRONOHOSPI  

Official title:

Circadian Health in Patients Admitted to Intensive Care Units and Hospitalization (CHRONOHOSPI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113876
• Other study ID #: PI18/2019-v3
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Instituto de Salud Carlos III
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 975
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronobiology Disorders

Locations

Country	Name	City	State
Spain	Teresa Moreno Casbas	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Salud Carlos III	Institut de Recerca Biomèdica de Lleida, Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

References & Publications (27)

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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. — View Citation

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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. — View Citation

Martínez Nicolás AB, Blázquez Manzanera A. La hora de nuestro cuerpo. Monitorización Ambulatoria Circadiana. Revista Eubacteria 2015; 33: 22-28.

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 — View Citation

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. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian Health	Using the KRONOHEALTH® recording device, we will measure the following indicators: Total Sleep Time; Sleep Fragmentations; Sleep depth; Chronobiological health index	96 hours
Secondary	Subjective Sleep Quality	Scores in the Pittsburgh sleep quality index	1 day (one time evaluation)
Secondary	Degree of sleep interference during hospitalization	Visual analogue scale from 0 to 10 points.	1 day (one time evaluation)

External Links

•   Division of Sleep Medicine at Harvard Medical School. Sleep and disease risk. 2007