Circadian Dysregulation Clinical Trial
— CHRONOCRITOfficial title:
Compromised Sleep and Circadian Health After Critical Illness: From Diagnosis to Prediction (CHRONOCRIT)
The intensive care unit (ICU) is recognizably detrimental to sleep and circadian health, and critical survivors frequently report the presence of alterations in this regard after hospital discharge. However, an appropriate evaluation of sleep and circadian rhythms is often neglected given the high associated cost and/or the need of collaboration of the patients. In this project, the investigators propose alternatives to ultimately improve the management of sleep and circadian health after critical illness. The researchers will evaluate the role of microRNA (miRNAs) expression profile in identifying the compromised sleep and circadian health of critical patients during the ICU stay, in the short (3 months after hospital discharge), and in the long-term (12 months after hospital discharge). Also, models based on machine learning techniques will be developed to predict adverse outcomes in this regard after hospital discharge.
Status | Recruiting |
Enrollment | 271 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Being older than 18 years old. - Intensive care unit admission. - Intensive care unit stay =7 days. Exclusion Criteria: - Transference to another hospital during hospitalization or follow-up. - Mental or physical disability that could prevent the proposed evaluations. - Palliative care |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Arnau de Vilanova | Lleida |
Lead Sponsor | Collaborator |
---|---|
Institut de Recerca Biomèdica de Lleida | Instituto de Salud Carlos III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep efficiency | The sleep health of critical patients will be evaluated using this parameter, which will be obtained through 7 days of actigraphy at the 3- and 12-month follow-up. Sleep efficiency is defined as the ratio between total sleep time and the time spent in bed. The following cut-offs are used: i) sleep efficiency = 85% (represents good sleep quality), ii) sleep efficiency <85% (represents inappropriate sleep quality). | 12-month follow-up | |
Primary | Circadian function index (CFI) | The circadian health of critical patients will be evaluated using this parameter, which will be obtained through 7 days of actigraphy at the 3- and 12-month follow-up. The circadian function index is defined as the average of intradaily variability, interdaily stability, and relative amplitude of the rhythm. There are no specific cut-offs for this parameter. The circadian function index values range from 0-1, in which 1 represents an appropriate circadian function. | 12-month follow-up |
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