Circadian Health and Influential Factors (CHRONOHOSPI)

February 28, 2023 updated by: Teresa Moreno Casbas, Instituto de Salud Carlos III

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

975

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28029
        • Teresa Moreno Casbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circadian Health
Time Frame: 96 hours

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Sleep Quality
Time Frame: 1 day (one time evaluation)
Scores in the Pittsburgh sleep quality index
1 day (one time evaluation)
Degree of sleep interference during hospitalization
Time Frame: 1 day (one time evaluation)
Visual analogue scale from 0 to 10 points.
1 day (one time evaluation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Salud Carlos III

Collaborators

Institut de Recerca Biomèdica de Lleida
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI18/2019-v3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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