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Chronobiology DisordersCHRONOHOSPINCT04113876

Circadian Health and Influential Factors

An observational study of Chronobiology Disorders, run by Instituto de Salud Carlos III at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronobiology Disorders
How many people
975 participants
Where
1 siteSpain
Study dates
1 Jan 2019to 31 Dec 2022
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Teresa Moreno Casbas

    Madrid, 28029

Other trials in Spain

About this study

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

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.

Read the detailed 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.

Keywords
sleep quality, circadian rhythm, nursing activities
Medical subject headings
Chronobiology Disorders, Sleep Initiation and Maintenance Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circadian Health

    Using the KRONOHEALTH® recording device, we will measure the following indicators:

    • Total Sleep Time
    • Sleep Fragmentations
    • Sleep depth
    • Chronobiological health index

    Measured: 96 hours

Secondary outcomes (2)

  1. Subjective Sleep Quality

    Scores in the Pittsburgh sleep quality index

    Measured: 1 day (one time evaluation)

  2. Degree of sleep interference during hospitalization

    Visual analogue scale from 0 to 10 points.

    Measured: 1 day (one time evaluation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
975 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04113876
Sponsor's protocol ID
PI18/2019-v3
Acronym
CHRONOHOSPI
Status last verified
Feb 2023
First submitted
6 Sep 2019
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23494200

  • 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.

    PubMed 19215573

  • 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.

    PubMed 20580916

  • 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.

    PubMed 16251950

  • 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.

    PubMed 16376591

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

  • 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].

  • 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.

    PubMed 23515802

  • 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.

    PubMed 26148316

  • 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.

    PubMed 26468189

  • 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.

    PubMed 10704520

  • 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.

    PubMed 19454302

  • 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.

    PubMed 11604479

  • 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.

    PubMed 17369106

  • Venkateshiah SB, Collop NA. Sleep and sleep disorders in the hospital. Chest. 2012 May;141(5):1337-1345. doi: 10.1378/chest.11-2591.

    PubMed 22553268

Questions about this trial

What is this clinical trial studying?

An observational study of Chronobiology Disorders, run by Instituto de Salud Carlos III at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circadian Health (time frame: 96 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04113876, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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