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Circadian DysregulationCHRONOCRITNCT05995132

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

An observational study of Circadian Dysregulation and Sleep Fragmentation, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Circadian Dysregulation, Sleep Fragmentation
How many people
271 participants
Where
1 siteSpain
Study dates
27 Sep 2023to Dec 2024
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
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Adriano Targa Dias Santos, PhD contact

+34 973702491

adrianotargads@gmail.com

David de Gonzalo Calvo, PhD contact

+34 973702491

dgonzalo@irblleida.cat

Spain1 site, 1 recruiting
  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

    Adriano Targa, PhD, adrianotargads@gmail.com

    Recruiting

Other trials in Spain

About this study

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.

Read the detailed description

The intensive care unit environment is recognizably detrimental for sleep and circadian rhythms due to a plethora of factors such as the mistimed and excessive use of artificial light, unusual feeding schedules, night-time noise and interruptions, events associated with acute illness, among others. The reported sleep and circadian alterations often persist after hospital discharge, but there is a lack of quantitative data obtained through appropriate tools for the intensive care unit context, with a proper sample size, and comprising the different profiles of critical patients. The investigators will address this, by evaluating the prevalence of sleep and circadian alterations during the intensive care unit stay and after hospital discharge in the short (3-month follow-up) and long term (12-month follow-up). This will indicate the magnitude of the problem to the healthcare professionals. In the sequence, the investigators will evaluate whether the expected alterations in the sleep and circadian rhythms of critical survivors are associated with important factors for their recovery such as quality of life, mental health, respiratory, and immune function. This is especially relevant given that it will indicate possible clinical markers for compromised sleep and circadian health and thereby increase the probability of patients' referral to a sleep unit whenever a marker is observed.

Despite the frequent complaints of sleep and circadian alterations among critical survivors, the evaluation of sleep and circadian health within this context is often neglected due to a high associated cost and/or the need of collaboration of the patients, which is not always possible. This proposal aims to counteract this matter, by identifying sleep and circadian alterations with the use of a non-invasive, feasible, and reliable approach. Accordingly, the investigators propose to identify such alterations by evaluating the levels of miRNAs, small molecules that are easily obtained through blood collection. This has the potential to increase the overlooked evaluations of sleep and circadian rhythms within this context. Furthermore, with a prompt identification of sleep and circadian alterations, appropriate strategies can be implemented, improving the quality of life and recovery of the patients, also preventing the outcomes associated with compromised sleep and circadian health in the long-term. Finally, the investigators propose to predict sleep and circadian alterations by integrating the information available during the intensive care unit stay with the use of informatic techniques. By doing so, the pertinent management will be implemented according to the needs of each patient. A proper follow-up contributes to the prompt identification of problems in this regard and consequent implementation of therapeutic strategies on time, potentiating the benefits of appropriate sleep and circadian health for the recovery and quality of life. It is important to note that such approach has the potential to aid in decreasing the time and cost-associated burden to which the healthcare system is exposed.

For doing all this, critical patients (n = 271) will be recruited during the ICU stay. Sleep and circadian rhythms will be assessed through actigraphy, and blood samples will be collected for miRNAs expression profile determination. Three months after hospital discharge, a clinical evaluation will be performed, followed by the assessment of the quality of life, mental health, and respiratory function. Sleep and circadian rhythms will be investigated through validated questionnaires and 7 consecutive days of actigraphy. Furthermore, blood will be collected for miRNAs expression profile determination and immune function evaluation. The same procedures will be performed 12 months after hospital discharge

The general objective of the study is to improve the management of sleep and circadian health after critical illness.

The specific objectives are:

  1. To evaluate the sleep and circadian health of critical patients in three time-points: during the intensive care unit stay, in the short-term (3 months after hospital discharge), and in the long-term (12 months after hospital discharge).
  2. To evaluate possible associations between sleep and circadian health and important factors for the recovery of critical survivors such as quality of life, mental health, respiratory, and immune function in the short and long-term.
  3. To evaluate the role of miRNAs expression profile in identifying the compromised sleep and circadian health of critical patients during the intensive care unit stay, in the short, and in the long-term.
  4. To identify possible biological events underlying the compromised sleep and circadian health of critical patients during the intensive care unit stay, in the short, and in the long-term.
  5. To develop models to predict the compromised sleep and circadian health of critical survivors in the short and long-term.
  6. To establish a cohort of critical survivors with available information related to sleep and circadian health to further explore this unravelled research field.
  7. To validate the findings in an independent cohort outside Europe.
Keywords
microRNA, circadian rhythms, intensive care unit, sleep, critical survivors
Medical subject headings
Chronobiology Disorders, Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05995132
Study groupRoleWhat they receive
Intensive care unitThis 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 ventilationThis group will be composed of patients admitted to the intensive care unit who did receive invasive mechanical ventilation.

What is being measured

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

  1. 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).

    Measured: 12-month follow-up

  2. 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.

    Measured: 12-month follow-up

Timeline

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

  1. First posted16 Aug 2023
  2. Study start27 Sep 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
271 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05995132
Sponsor's protocol ID
PI22/00216
Acronym
CHRONOCRIT
Status last verified
Sep 2023
First submitted
9 Aug 2023
Last updated
28 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Circadian Dysregulation and Sleep Fragmentation, run by Institut de Recerca Biomèdica de Lleida 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 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?

Results are not available in the source record.

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

Contact Adriano Targa Dias Santos, PhD (+34 973702491, adrianotargads@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep efficiency (time frame: 12-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Sep 2023.

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