Compromised Sleep and Circadian Health After Critical Illness: From Diagnosis to Prediction (CHRONOCRIT)

NCT05995132 | Unknown

• 1 other identifier: PI22/00216
• Study Type: observational
• Target: 271
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circadian Dysregulation; Sleep Fragmentation

Keywords

microRNA; circadian rhythms; intensive care unit; sleep; critical survivors

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Intensive care unit

This group will be composed of patients admitted to the intensive care unit who did not receive invasive mechanical ventilation.

Intensive care unit and invasive mechanical ventilation

This group will be composed of patients admitted to the intensive care unit who did receive invasive mechanical ventilation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critical patients admited to the intensive care unit of the Hospital Arnau de Vilanova de Lleida who meet the eligibility criteria.

You may qualify if:

• Being older than 18 years old.
• Intensive care unit admission.
• Intensive care unit stay ≥7 days.

You may not qualify if:

• Transference to another hospital during hospitalization or follow-up.
• Mental or physical disability that could prevent the proposed evaluations.
• Palliative care

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* 2 Tubes EDTA (6ml) * 1 tempus RNS tube (2,5 ml)

MeSH Terms

Conditions

Chronobiology Disorders; Sleep Deprivation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Adriano Targa Dias Santos, PhD

  Institut de Recerca Biomèdica de Lleida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriano Targa Dias Santos, PhD

CONTACT

+34 973702491; adrianotargads@gmail.com

David de Gonzalo Calvo, PhD

CONTACT

+34 973702491; dgonzalo@irblleida.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: September 27, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)