Circadian RhythmNCT07811492
CIRCA-MED WP1 & WP3 - Circadian Rhythms in ICU Patients
An observational study of Circadian Rhythm, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The goal of this retrospective exploratory study is to examine how the body's natural day-and-night rhythms and oscillatory patterns behave in people who were treated in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circadian Rhythm
- What is being tested?
- Exposure to routine clinical parameters, Exposure to ICU clinical factors and treatments and Exposure to critical illness-related conditions
- How many people
- 25,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2025to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Charite University, Berlin, Germany
Who may be able to join
- Primary Retrospective Cohort:
- Admitted to and treated in a participating Intensive Care Unit (ICU) between 2017 and 2024
- Minimum ICU length of stay of 3 days (≥ 72 hours)
- Age ≥ 18 years at the time of ICU admission
- All genders (male, female, diverse)
- Cohorts from previous studies:
- Prior enrollment in one of the designated parent study protocols
- Availability of supplementary biological or metabolic data (e.g., clock gene expression, melatonin levels) suitable for exploratory association analyses
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Informatics, Charite University, Berlin
Berlin, 10117
About this study
Official title: Retrospective Characterization of Circadian Rhythms Using Vital Signs and Other Routine Data From Patients in the Intensive Care Unit
The goal of this retrospective exploratory study is to examine how the body's natural day-and-night rhythms and oscillatory patterns behave in people who were treated in the Intensive Care Unit (ICU). The study uses routine clinical data that were already collected during and after the ICU stay, including post-discharge follow-up measurements (where available), such as heart rate, temperature, blood pressure, blood sugar, and insulin. The researchers want to learn whether these measurements show daily patterns and whether patients can be grouped based on their oscillatory profiles. The study also examines whether certain clinical factors such as illness severity scores, sedation levels, organ support treatments, or medications are associated with changes in these oscillatory rhythms. The team will explore whether conditions that can develop during or after critical illness, such as delirium, muscle weakness, or Post-Intensive Care Syndrome (PICS), are linked to disturbed physiological rhythms. Another goal is to test whether it is technically possible to show a patient's rhythm profile in real time using routine data from the ICU information system, evaluated retrospectively. Digital tools called "Chrono-Apps" will be developed to display rhythmic information and may help clinicians adjust lighting to patient needs.
Read the detailed description
The investigators will retrospectively analyze periodic oscillations in clinical data, such as heart rate, temperature, blood glucose, insulin, or blood pressure, to identify parameters suitable for characterizing the physiological rhythms in hospitalized Intensive Care Unit (ICU) patients. While these measurements typically show regular daily changes, also called oscillatory patterns, critical illness, continuous monitoring, and frequent medical interventions can disrupt them. The study will investigate whether these patterns can be used to group patients into distinct temporal or rhythmic profiles. The study will also examine whether certain clinical factors are linked to functioning or disrupted oscillatory patterns. These factors include illness severity scores, sedation levels, organ support treatments, and medications. Additionally, the researchers will explore whether temporal disruption is associated with key ICU complications, including delirium, ICU-acquired muscle weakness, and Post-Intensive Care Syndrome (PICS). Finally, in a small cohort of ICU patients, the investigators will test personalized lighting regimens adapted to individual chronotypes. This phase of the study aims to assess the robustness of routine clinical data for tailoring light exposure, validate a circadian entrainment algorithm, and evaluate potential sources of bias. Real-time analyses of clinical data will be visualized as rhythm profiles via digital "Chrono-Apps" integrated into the electronic patient record. These visualizations will support the day-to-day implementation of personalized lighting regimens that adapt dynamically to each patient's current rhythm status and clinical condition.
- Conditions
- Circadian Rhythm
- Being tested
- Exposure to routine clinical parameters, Exposure to ICU clinical factors and treatments, Exposure to critical illness-related conditions, Exposure to molecular and hormonal circadian markers, Exposure to metabolic changes related to critical illness
- Keywords
- wavelet analysis, ICU, vital oscillations, rhythms, clinical outcomes, chrono-apps, biodynamic lighting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to routine clinical parametersOther
These are the primary exposures and are used to detect oscillatory patterns and characterize circadian rhythms. They include heart rate, body temperature, blood pressure, blood glucose, and insulin.
Exposure to ICU clinical factors and treatmentsOther
These are secondary exposures that may influence circadian rhythms: illness severity (e.g., Sequential Organ Failure Assessment (SOFA) score), sedation levels, organ support therapies (e.g., ventilation, dialysis, Extracorporeal Membrane Oxygenation (ECMO)), and medications administered during ICU stay (e.g., sedatives, vasopressors, corticosteroids).
Exposure to critical illness-related conditionsOther
These exposures represent complications that may be associated with circadian disruption: delirium, deep sedation, ICU-acquired muscle weakness, and post-intensive care syndrome.
Exposure to molecular and hormonal circadian markersOther
These exposures reflect biological clock function: clock gene expression (if available in some cases), and melatonin levels.
Exposure to metabolic changes related to critical illnessOther
These exposures represent metabolic consequences of critical illness: insulin sensitivity, muscle atrophy, and critical illness myopathy or ICU-acquired weakness.
| Study group | Role | What they receive |
|---|---|---|
| All retrospective patients between 2017 and 2024 | Relates to retrospective data from all patients who spent at least three days in participating intensive care units at Charite University, Berlin, Germany between 2017 and 2024 Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions | |
| Pa-COVID (DRKS00021688) | Not described Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions; Other: Exposure to molecular and hormonal circadian markers | |
| SeptiCLOCK (NCT02044575) | Not described Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions; Other: Exposure to molecular and hormonal circadian markers | |
| VITALITY (NCT02143661) | Not described Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions; Other: Exposure to molecular and hormonal circadian markers | |
| TRG-N (ISRCTN77569430) | Not described Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions; Other: Exposure to molecular and hormonal circadian markers; Other: Exposure to metabolic changes related to critical illness | |
| CIPCIM2 (ISRCTN19392591) | Not described Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions; Other: Exposure to molecular and hormonal circadian markers; Other: Exposure to metabolic changes related to critical illness | |
| CGM (NCT02296372) | Not described Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions | |
| HELIA-ICU (NCT05556811) | Not described Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions; Other: Exposure to molecular and hormonal circadian markers | |
| PICS-Analyse (EA1/229/24) | Not described Receives: Other: Exposure to routine clinical parameters; Other: Exposure to ICU clinical factors and treatments; Other: Exposure to critical illness-related conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of circadian periodicities and classification of time-varying patterns based on routine clinical data
Assessment of periodicities and time-varying patterns in routine clinical parameters, including heart rate, body temperature, blood pressure, blood glucose, and insulin levels. Time-series analysis will be conducted to extract continuous metrics (amplitude, period, and phase). Based on these metrics, patients will be classified into distinct categorical groups according to their periodic oscillation profiles.
Measured: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).
Secondary outcomes (5)
Association between circadian rhythm category and clinical severity scores
Relationship between circadian rhythm classification and illness severity (e.g., SOFA score), sedation level, and use of organ support therapies.
Measured: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).
Association between circadian rhythm disruption and critical illness-related conditions
Presence of delirium, ICU-acquired muscle weakness/critical illness myopathy, and PICS in relation to circadian rhythm category. Delirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) binary scale (Positive/Negative).
Measured: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks), and post-ICU period (up to 3 and 6 months).
Association between time-varying clinical patterns and external biological markers (from other studies)
Exploratory associations between oscillatory trends in routine clinical data and biological markers reported in other studies, such as clock gene expression, melatonin levels, insulin sensitivity, muscle atrophy, and critical illness myopathy. Only associations will be evaluated.
Measured: Depending on individual study protocols, from ICU admission through 24 months post-discharge. Sampled daily to weekly during the ICU stay, followed by post-discharge examinations conducted at variable monthly intervals (a maximum of 5 visits).
Feasibility and Data Infrastructure for Real-Time Circadian Visualization (Chrono-Apps)
Evaluation of the technical feasibility and data integration requirements for generating real-time circadian visualizations within the Patient Data Management System (PDMS). Feasibility will be assessed based on data completeness, sampling frequency compliance, latency of time-series data streaming from routine ICU monitors, and system stability required to display continuous circadian profiles via Chrono-Apps.
Measured: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).
Performance of Algorithm-Based Light Therapy Recommendations
Retrospective evaluation of the accuracy and stability of the time-series analysis designed to estimate circadian phase of routine clinical data (vital signs) and generate individualized lighting schedules.
Measured: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Oct 2025
- Primary completion31 May 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Balzer, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811492
- Sponsor's protocol ID
- EA1/284/22
- Other IDs
- 541063275 - TRR 418
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Characterization of Circadian Rhythms Using Vital Signs and Other Routine Data From Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07811492
- Acronym / sponsor ID
- EA1/284/22
- Conditions
- Circadian Rhythm
- Keywords
- wavelet analysis, ICU, vital oscillations, rhythms, clinical outcomes, chrono-apps, biodynamic lighting
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this retrospective exploratory study is to examine how the body's natural day-and-night rhythms and oscillatory patterns behave in people who were treated in the Intensive Care Unit (ICU). The study uses routine clinical data that were already collected during and after the ICU stay, including post-discharge follow-up measurements (where available), such as heart rate, temperature, blood pressure, blood sugar, and insulin. The researchers want to learn whether these measurements show daily patterns and whether patients can be grouped based on their oscillatory profiles. The study also examines whether certain clinical factors such as illness severity scores, sedation levels, organ support treatments, or medications are associated with changes in these oscillatory rhythms. The team will explore whether conditions that can develop during or after critical illness, such as delirium, muscle weakness, or Post-Intensive Care Syndrome (PICS), are linked to disturbed physiological rhythms. Another goal is to test whether it is technically possible to show a patient's rhythm profile in real time using routine data from the ICU information system, evaluated retrospectively. Digital tools called "Chrono-Apps" will be developed to display rhythmic information and may help clinicians adjust lighting to patient needs.
Detailed description
The investigators will retrospectively analyze periodic oscillations in clinical data, such as heart rate, temperature, blood glucose, insulin, or blood pressure, to identify parameters suitable for characterizing the physiological rhythms in hospitalized Intensive Care Unit (ICU) patients. While these measurements typically show regular daily changes, also called oscillatory patterns, critical illness, continuous monitoring, and frequent medical interventions can disrupt them. The study will investigate whether these patterns can be used to group patients into distinct temporal or rhythmic profiles. The study will also examine whether certain clinical factors are linked to functioning or disrupted oscillatory patterns. These factors include illness severity scores, sedation levels, organ support treatments, and medications. Additionally, the researchers will explore whether temporal disruption is associated with key ICU complications, including delirium, ICU-acquired muscle weakness, and Post-Intensive Care Syndrome (PICS). Finally, in a small cohort of ICU patients, the investigators will test personalized lighting regimens adapted to individual chronotypes. This phase of the study aims to assess the robustness of routine clinical data for tailoring light exposure, validate a circadian entrainment algorithm, and evaluate potential sources of bias. Real-time analyses of clinical data will be visualized as rhythm profiles via digital "Chrono-Apps" integrated into the electronic patient record. These visualizations will support the day-to-day implementation of personalized lighting regimens that adapt dynamically to each patient's current rhythm status and clinical condition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| All retrospective patients between 2017 and 2024 | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditionsRelates to retrospective data from all patients who spent at least three days in participating intensive care units at Charite University, Berlin, Germany between 2017 and 2024 |
| Pa-COVID (DRKS00021688) | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditions, Other: Exposure to molecular and hormonal circadian markers |
| SeptiCLOCK (NCT02044575) | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditions, Other: Exposure to molecular and hormonal circadian markers |
| VITALITY (NCT02143661) | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditions, Other: Exposure to molecular and hormonal circadian markers |
| TRG-N (ISRCTN77569430) | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditions, Other: Exposure to molecular and hormonal circadian markers, Other: Exposure to metabolic changes related to critical illness |
| CIPCIM2 (ISRCTN19392591) | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditions, Other: Exposure to molecular and hormonal circadian markers, Other: Exposure to metabolic changes related to critical illness |
| CGM (NCT02296372) | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditions |
| HELIA-ICU (NCT05556811) | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditions, Other: Exposure to molecular and hormonal circadian markers |
| PICS-Analyse (EA1/229/24) | – | Other: Exposure to routine clinical parameters, Other: Exposure to ICU clinical factors and treatments, Other: Exposure to critical illness-related conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Charite University, Berlin, Germany
Key inclusion criteria (8 listed)
- Admitted to and treated in a participating Intensive Care Unit (ICU) between 2017 and 2024
- Minimum ICU length of stay of 3 days (≥ 72 hours)
- Age ≥ 18 years at the time of ICU admission
- All genders (male, female, diverse)
- Prior enrollment in one of the designated parent study protocols
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to routine clinical parametersThese are the primary exposures and are used to detect oscillatory patterns and characterize circadian rhythms. They include heart rate, body temperature, blood pressure, blood glucose, and insulin. | Other | All retrospective patients between 2017 and 2024, CGM (NCT02296372), CIPCIM2 (ISRCTN19392591), HELIA-ICU (NCT05556811), PICS-Analyse (EA1/229/24), Pa-COVID (DRKS00021688), SeptiCLOCK (NCT02044575), TRG-N (ISRCTN77569430), VITALITY (NCT02143661) |
| Exposure to ICU clinical factors and treatmentsThese are secondary exposures that may influence circadian rhythms: illness severity (e.g., Sequential Organ Failure Assessment (SOFA) score), sedation levels, organ support therapies (e.g., ventilation, dialysis, Extracorporeal Membrane Oxygenation (ECMO)), and medications administered during ICU stay (e.g., sedatives, vasopressors, corticosteroids). | Other | All retrospective patients between 2017 and 2024, CGM (NCT02296372), CIPCIM2 (ISRCTN19392591), HELIA-ICU (NCT05556811), PICS-Analyse (EA1/229/24), Pa-COVID (DRKS00021688), SeptiCLOCK (NCT02044575), TRG-N (ISRCTN77569430), VITALITY (NCT02143661) |
| Exposure to critical illness-related conditionsThese exposures represent complications that may be associated with circadian disruption: delirium, deep sedation, ICU-acquired muscle weakness, and post-intensive care syndrome. | Other | All retrospective patients between 2017 and 2024, CGM (NCT02296372), CIPCIM2 (ISRCTN19392591), HELIA-ICU (NCT05556811), PICS-Analyse (EA1/229/24), Pa-COVID (DRKS00021688), SeptiCLOCK (NCT02044575), TRG-N (ISRCTN77569430), VITALITY (NCT02143661) |
| Exposure to molecular and hormonal circadian markersThese exposures reflect biological clock function: clock gene expression (if available in some cases), and melatonin levels. | Other | CIPCIM2 (ISRCTN19392591), HELIA-ICU (NCT05556811), Pa-COVID (DRKS00021688), SeptiCLOCK (NCT02044575), TRG-N (ISRCTN77569430), VITALITY (NCT02143661) |
| Exposure to metabolic changes related to critical illnessThese exposures represent metabolic consequences of critical illness: insulin sensitivity, muscle atrophy, and critical illness myopathy or ICU-acquired weakness. | Other | CIPCIM2 (ISRCTN19392591), TRG-N (ISRCTN77569430) |
Primary outcome
Characterization of circadian periodicities and classification of time-varying patterns based on routine clinical data
Time frame: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).
Assessment of periodicities and time-varying patterns in routine clinical parameters, including heart rate, body temperature, blood pressure, blood glucose, and insulin levels. Time-series analysis will be conducted to extract continuous metrics (amplitude, period, and phase). Based on these metrics, patients will be classified into distinct categorical groups according to their periodic oscillation profiles.
5 secondary outcomes
Association between circadian rhythm category and clinical severity scores
Time frame: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).
Association between circadian rhythm disruption and critical illness-related conditions
Time frame: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks), and post-ICU period (up to 3 and 6 months).
Association between time-varying clinical patterns and external biological markers (from other studies)
Time frame: Depending on individual study protocols, from ICU admission through 24 months post-discharge. Sampled daily to weekly during the ICU stay, followed by post-discharge examinations conducted at variable monthly intervals (a maximum of 5 visits).
Feasibility and Data Infrastructure for Real-Time Circadian Visualization (Chrono-Apps)
Time frame: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).
Performance of Algorithm-Based Light Therapy Recommendations
Time frame: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm, run by Charite University, Berlin, Germany at 1 site in Germany.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Characterization of circadian periodicities and classification of time-varying patterns based on routine clinical data (time frame: From ICU admission to ICU discharge or death, whichever comes first (expected average duration of 4 weeks).). 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 10 Sep 2026.