Critical IllnessReAlign-ICUNCT05551325
Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle
A study testing Chronobundle - light, chronobundle - feeding and chronobundle - mobility in people with Critical Illness and Sleep Deprivation, run by Yale University at 2 sites in United States.
Trial summary
More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sleep Deprivation, Circadian Rhythm Sleep Disorder, Unspecified
- What is being tested?
- Chronobundle - light, chronobundle - feeding and chronobundle - mobility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2024to 29 Jun 2029
- Phase
- Interventional
- 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
Who may be able to join
- Critically ill patients admitted to the MICU who require mechanical ventilation, noninvasive ventilation, high flow nasal cannula, or vasopressor support and who remain on qualifying support as of 09:00 on study randomization day. Randomization will occur on the second or third calendar day following MICU admission. MICU admission must have occurred within 24 hours of hospital admission.
- Age greater than or equal to 18 years old.
Who cannot join
- Not expected to remain in the MICU for at least 48 hours post-randomization.
- Imminently dying or with a hospice status.
- At significant risk for pre-existing circadian abnormalities including: (1) severe chronic brain injury (injury greater than 30 days ago resulting in the inability to live independently); (2) acute brain injury of any severity that is reasonably expected to impact the central circadian clock (e.g., cardiac arrest); (3) documented circadian disorder (<1% population) or blind/disease of the optic nerve; (4) current or recent (last 1 year) shiftwork; and (5) homelessness, incarceration, or institutionalization.
- At elevated risk of aspiration due to structural or functional abnormality of the gastrointestinal tract OR fed via enteral nutrition (e.g., "tube feeds") prior to ICU admission.
- Admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state; this diagnosis will be established via review of the medical record for a description of diabetes in the past medical history or the presence of diabetes medication on the confirmed home medication list AND hyperglycemia attributed to diabetic ketoacidosis or diabetic hyperosmolar state by the admitting care team in their written assessment of the patient.
- Having a history of hypoglycemia without documented full neurological recovery; this diagnosis will be established via review of the patient's past medical history in the medical record;
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- Having a history suggesting an abnormally high risk of suffering hypoglycemia (e.g., known insulin secreting tumor, history of unexplained or recurrent hypoglycemia or fulminant hepatic failure); this diagnosis will be established via review of the patient's past medical history in the medical record.
- Admitted due to complications of a suicide attempt.
- Admitted due to an acute drug overdose or active alcohol withdrawal.
- Positive for SARS-CoV.
- Urine 6-sulfatoxymelatonin measures will be considered for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points. However, we will exclude patients from urine measures if they have a history or positive test for any known disease or illness that would categorize biological samples as BSL3 or higher. This includes HIV, West Nile virus, Monkeypox, and Mycobacterium tuberculosis (TB).
- Note: Patients who leave the MICU within 24 hours of randomization are excluded from further study activities. Patients who leave the MICU between 24 and 48 hours post-randomization continue all study activities but will not be included in the primary analysis. Patients who remain in the MICU for at least 48 hours post-randomization will continue all study activities and be included in the primary analysis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus
New Haven, Connecticut, 06520
- Recruiting
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street
New Haven, Connecticut, 06520
About this study
Official title: Reestablishing Sleep and Circadian Alignment in Medically Critically Ill Patients Via a Mechanistic Randomized Controlled Trial (RCT) of an Intensive Care Unit (ICU) Sleep Chronobundle
More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as sleep and eating at normal body clock times, which is predicted to improve sleep quality and metabolic function. This project will test the ability of a sleep chronobundle (i.e., sleep promotion and circadian treatment bundle) to normalize circadian alignment and subsequently test if this realignment also improves sleep and metabolism.
Read the detailed description
An evidence-based treatment that simultaneously addresses intensive care unit (ICU) sleep and circadian disruption (SCD) is desperately needed. Such treatment is needed because patients admitted to the ICU are at high risk for adverse outcomes resulting directly from acute SCD. It is well established among healthy controls that acute SCD is associated with immediate negative consequences such as metabolic, cognitive, cardiovascular, respiratory, skeletal muscle, and immune dysfunction. Normalization of sleep and circadian processes improves these dysfunctions. In the ICU, sleep and circadian processes cannot be segregated, and there are likely several overlapping domains of SCD (e.g., sleep duration, timing, architecture, and continuity, and circadian alignment and amplitude). Thus, a bundled approach to sleep and circadian promotion holds the most promise for reversing SCD, normalizing broader physiologic disruptions, and improving ICU outcomes.
To date, ICU sleep promotion bundles have had limited success in documenting improved sleep, and sleep bundles have commonly ignored circadian disruption and circadian-based sleep promotion strategies. This is a critical gap. Translation of circadian principles to ICU sleep promotion is essential because alignment between biologic and clock time allows for subsequent strategic scheduling of behaviors, for example, scheduling sleep promotion during the biologic night to improve sleep duration and quality. In addition, circadian alignment has broader physiologic implications and related potential to improve function across a wide variety of organ systems, for example, scheduling eating during the biologic day to improve glucose tolerance. Investigations to date have not tested the effect of a multifaceted intervention that includes promotion of both circadian alignment via photic and nonphotic zeitgebers and overnight sleep via non-pharmacologic strategies (sleep chronobundle).
The overall objective of this project is to test whether a sleep chronobundle, including daytime bright light, time-restricted daytime feeding, increased daytime mobility, and overnight sleep promotion mitigates ICU SCD. A mechanistic randomized controlled trial will be used to test our central hypotheses that a sleep chronobundle will (1) align biologic and clock day-night; (2) overlap behaviors (e.g., sleeping and eating) correctly with biologic time periods; and therefore (3) improve sleep and metabolic processes in the ICU. The focus of this study is on sleep and glucose metabolism metrics because of their high relevance to critical illness.
- Being tested
- Chronobundle - light, chronobundle - feeding, chronobundle - mobility, chronobundle - sleep
- Keywords
- critical illness, sleep deficiency, circadian misalignment
- Medical subject headings
- Critical Illness, Sleep Deprivation, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronobundle - lightOther
Bright daytime light from 09:00 to 13:00 starting on day 1. The light will be 10,000 lux at 12" and provide a minimal intensity of 1,250 lux at the angle of the eye (30" to 36" distance). The light has a temperature of 5,000 Kelvin indicating a high blue wavelength content which should maximize circadian effects (validated device Sunbox Lighting, Maryland). Following the 09:00 to 13:00 bright light, the room lights will remain on and the curtains will remain open to maximize daytime light exposure while not decreasing bright light tolerance.
chronobundle - feedingOther
For patients receiving enteral feeds, time-restricted (daytime) intermittent feeding will include 4 meals delivered at 08:00, 12:00, 16:00 and 20:00. Each meal will include one-fourth of the recommended daily tube feed volume.
chronobundle - mobilityOther
While in the MICU, exercise/mobility sessions led by physical therapy or occupational therapy providers will occur twice daily between 09:00 and 16:00 (i.e., one additional session beyond usual care); intensity will be determined by clinical status and documented in the chart by our physical therapy service. Patients in other hospital locations (e.g., general medical ward post-MICU discharge) will receive one additional session beyond usual care via a study staff-led exercise/mobility session; intensity will be determined by clinical status.
chronobundle - sleepOther
Overnight sleep promotion will occur between 22:00 and 06:00 with a more restricted sleep period between 00:00 and 04:00. This will be achieved by rescheduling non-urgent care. There will be no changes to urgent care. Additionally, room lights will be dimmed, curtains drawn, and room doors closed. Television screens will be fitted with blue light-blocking filters.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual ICU care. |
| Chronobundle | Experimental | The chronobundle will include bright daytime light, time-restricted intermittent feeding, enhanced exercise/mobility, and overnight sleep promotion. Receives: Other: Chronobundle - light; Other: chronobundle - feeding; Other: chronobundle - mobility; Other: chronobundle - sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian alignment based on diurnal heart rate variation
Individual heart rate nadir compared to population normal nadir of 04:00. Maximum difference +/- 12 hours.
Measured: post-treatment, 72 hours
Secondary outcomes (17)
Urine 6-sulfatoxymelatonin acrophase change from normal
Individual urine 6-sulfatoxymelatonin acrophase compared to population normal acrophase of 03:30. Maximum difference +/- 12 hours. Urine 6-sulfatoxymelatonin measures will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Measured: post-treatment, 72 hours
Urine 6-sulfatoxymelatonin acrophase absolute time
Clock time of individual urine 6-sulfatoxymelatonin acrophase. Urine 6-sulfatoxymelatonin measures will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Measured: post-treatment, 72 hours
Urine 6-sulfatoxymelatonin acrophase change from day 1 to day 4
Change in individual urine 6-sulfatoxymelatonin acrophase between day 1 observation and day 4 observation period (after 72 hours intervention). Urine 6-sulfatoxymelatonin measures will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Measured: Day 1 and post-treatment, 72 hours
Overnight sleep duration
Minutes of sleep from 22:00 to 05:59 as measured by NoxA1 portable polysomnography (PSG) device.
Measured: post-treatment, 72 hours
Overnight Rapid Eye Movement (REM) proportion
Proportion of Stage REM sleep from 22:00 to 05:59 as measured by NoxA1 portable polysomnography device.
Measured: post-treatment, 72 hours
Overnight non-rapid eye movement stage 3 (NREM3) proportion
Proportion of Stage NREM3 sleep from 22:00 to 05:59 as measured by NoxA1 portable polysomnography device.
Measured: post-treatment, 72 hours
Overnight arousal index (continuity)
Number of arousals per hour of sleep from 22:00 to 05:59 as measured by NoxA1 portable polysomnography device.
Measured: post-treatment, 72 hours
Daytime sleep duration
Minutes of sleep from 06:00 to 21:59 as measured by NoxA1 portable polysomnography device.
Measured: post-treatment, 72 hours
Daytime REM proportion
Proportion of Stage REM sleep from 06:00 to 21:59 as measured by NoxA1 portable polysomnography device.
Measured: post-treatment, 72 hours
Daytime NREM3 proportion
Proportion of Stage NREM3 sleep from 06:00 to 21:59 as measured by NoxA1 portable polysomnography device.
Measured: post-treatment, 72 hours
Daytime arousal index (continuity)
Number of arousals per hour of sleep from 06:00 to 21:59 as measured by NoxA1 portable polysomnography device.
Measured: post-treatment, 72 hours
Biologic night sleep duration
Minutes of sleep during biologic night (melatonin onset to offset) as measured by NoxA1 portable polysomnography device. Biologic night determination will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Measured: post-treatment, 72 hours
Biologic night REM proportion
Proportion of Stage REM sleep during biologic night (melatonin onset to offset) as measured by NoxA1 portable polysomnography device. Biologic night determination will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Measured: post-treatment, 72 hours
Biologic night NREM3 proportion
Proportion of Stage NREM3 sleep during biologic night (melatonin onset to offset) as measured by NoxA1 portable polysomnography device. Biologic night determination will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Measured: post-treatment, 72 hours
Biologic night arousal index (continuity)
Number of arousals per hour of sleep during biologic night (melatonin onset to offset) as measured by NoxA1 portable polysomnography device. Biologic night determination will be completed for all patients who make sufficient urine and have an appropriate bladder catheter in place during the indicated time points.
Measured: post-treatment, 72 hours
Atypical sleep
Presence of atypical sleep on polysomnography recording, characterized by δ waves without cyclic organization, the absence of K-complexes and sleep spindles, and unusual sleep stage transitions.
Measured: post-treatment, 72 hours
Glucose tolerance
Area under the curve per 24 hour period of continuous glucose monitoring.
Measured: post-treatment, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start13 May 2024
- Primary completion29 Jun 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization of patients to control or intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Melissa P Knauert, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551325
- Sponsor's protocol ID
- 2000033373
- Other IDs
- 1R01HL163659-01A1
- Acronym
- ReAlign-ICU
- Status last verified
- May 2026
- First submitted
- 19 Sep 2022
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reestablishing Sleep and Circadian Alignment in Medically Critically Ill Patients Via a Mechanistic Randomized Controlled Trial (RCT) of an Intensive Care Unit (ICU) Sleep Chronobundle
- ClinicalTrials.gov ID
- NCT05551325
- Acronym / sponsor ID
- ReAlign-ICU / 2000033373
- Keywords
- critical illness, sleep deficiency, circadian misalignment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 29 Jun 2029 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 22 Sep 2022 (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.
More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as sleep and eating at normal body clock times, which is predicted to improve sleep quality and metabolic function. This project will test the ability of a sleep chronobundle (i.e., sleep promotion and circadian treatment bundle) to normalize circadian alignment and subsequently test if this realignment also improves sleep and metabolism.
Detailed description
An evidence-based treatment that simultaneously addresses intensive care unit (ICU) sleep and circadian disruption (SCD) is desperately needed. Such treatment is needed because patients admitted to the ICU are at high risk for adverse outcomes resulting directly from acute SCD. It is well established among healthy controls that acute SCD is associated with immediate negative consequences such as metabolic, cognitive, cardiovascular, respiratory, skeletal muscle, and immune dysfunction. Normalization of sleep and circadian processes improves these dysfunctions. In the ICU, sleep and circadian processes cannot be segregated, and there are likely several overlapping domains of SCD (e.g., sleep duration, timing, architecture, and continuity, and circadian alignment and amplitude). Thus, a bundled approach to sleep and circadian promotion holds the most promise for reversing SCD, normalizing broader physiologic disruptions, and improving ICU outcomes.
To date, ICU sleep promotion bundles have had limited success in documenting improved sleep, and sleep bundles have commonly ignored circadian disruption and circadian-based sleep promotion strategies. This is a critical gap. Translation of circadian principles to ICU sleep promotion is essential because alignment between biologic and clock time allows for subsequent strategic scheduling of behaviors, for example, scheduling sleep promotion during the biologic night to improve sleep duration and quality. In addition, circadian alignment has broader physiologic implications and related potential to improve function across a wide variety of organ systems, for example, scheduling eating during the biologic day to improve glucose tolerance. Investigations to date have not tested the effect of a multifaceted intervention that includes promotion of both circadian alignment via photic and nonphotic zeitgebers and overnight sleep via non-pharmacologic strategies (sleep chronobundle).
The overall objective of this project is to test whether a sleep chronobundle, including daytime bright light, time-restricted daytime feeding, increased daytime mobility, and overnight sleep promotion mitigates ICU SCD. A mechanistic randomized controlled trial will be used to test our central hypotheses that a sleep chronobundle will (1) align biologic and clock day-night; (2) overlap behaviors (e.g., sleeping and eating) correctly with biologic time periods; and therefore (3) improve sleep and metabolic processes in the ICU. The focus of this study is on sleep and glucose metabolism metrics because of their high relevance to critical illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization of patients to control or intervention
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual ICU care. |
| Chronobundle | Experimental | Other: Chronobundle - light, Other: chronobundle - feeding, Other: chronobundle - mobility, Other: chronobundle - sleepThe chronobundle will include bright daytime light, time-restricted intermittent feeding, enhanced exercise/mobility, and overnight sleep promotion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critically ill patients admitted to the MICU who require mechanical ventilation, noninvasive ventilation, high flow nasal cannula, or vasopressor support and who remain on qualifying support as of 09:00 on study randomization day. Randomization will occur on the second or third calendar day following MICU admission. MICU admission must have occurred within 24 hours of hospital admission.
- Age greater than or equal to 18 years old.
Key exclusion criteria (12 listed)
- Not expected to remain in the MICU for at least 48 hours post-randomization.
- Imminently dying or with a hospice status.
- At significant risk for pre-existing circadian abnormalities including: (1) severe chronic brain injury (injury greater than 30 days ago resulting in the inability to live independently); (2) acute brain injury of any severity that is reasonably expected to impact the central circadian clock (e.g., cardiac arrest); (3) documented circadian disorder (<1% population) or blind/disease of the optic nerve; (4) current or recent (last 1 year) shiftwork; and (5) homelessness, incarceration, or institutionalization.
- At elevated risk of aspiration due to structural or functional abnormality of the gastrointestinal tract OR fed via enteral nutrition (e.g., "tube feeds") prior to ICU admission.
- Admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state; this diagnosis will be established via review of the medical record for a description of diabetes in the past medical history or the presence of diabetes medication on the confirmed home medication list AND hyperglycemia attributed to diabetic ketoacidosis or diabetic hyperosmolar state by the admitting care team in their written assessment of the patient.
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 |
|---|---|---|
| Chronobundle - lightBright daytime light from 09:00 to 13:00 starting on day 1. The light will be 10,000 lux at 12" and provide a minimal intensity of 1,250 lux at the angle of the eye (30" to 36" distance). The light has a temperature of 5,000 Kelvin indicating a high blue wavelength content which should maximize circadian effects (validated device Sunbox Lighting, Maryland). Following the 09:00 to 13:00 bright light, the room lights will remain on and the curtains will remain open to maximize daytime light exposure while not decreasing bright light tolerance. | Other | Chronobundle |
| chronobundle - feedingFor patients receiving enteral feeds, time-restricted (daytime) intermittent feeding will include 4 meals delivered at 08:00, 12:00, 16:00 and 20:00. Each meal will include one-fourth of the recommended daily tube feed volume. | Other | Chronobundle |
| chronobundle - mobilityWhile in the MICU, exercise/mobility sessions led by physical therapy or occupational therapy providers will occur twice daily between 09:00 and 16:00 (i.e., one additional session beyond usual care); intensity will be determined by clinical status and documented in the chart by our physical therapy service. Patients in other hospital locations (e.g., general medical ward post-MICU discharge) will receive one additional session beyond usual care via a study staff-led exercise/mobility session; intensity will be determined by clinical status. | Other | Chronobundle |
| chronobundle - sleepOvernight sleep promotion will occur between 22:00 and 06:00 with a more restricted sleep period between 00:00 and 04:00. This will be achieved by rescheduling non-urgent care. There will be no changes to urgent care. Additionally, room lights will be dimmed, curtains drawn, and room doors closed. Television screens will be fitted with blue light-blocking filters. | Other | Chronobundle |
Primary outcome
Circadian alignment based on diurnal heart rate variation
Time frame: post-treatment, 72 hours
Individual heart rate nadir compared to population normal nadir of 04:00. Maximum difference +/- 12 hours.
17 secondary outcomes
Urine 6-sulfatoxymelatonin acrophase change from normal
Time frame: post-treatment, 72 hours
Urine 6-sulfatoxymelatonin acrophase absolute time
Time frame: post-treatment, 72 hours
Urine 6-sulfatoxymelatonin acrophase change from day 1 to day 4
Time frame: Day 1 and post-treatment, 72 hours
Overnight sleep duration
Time frame: post-treatment, 72 hours
Overnight Rapid Eye Movement (REM) proportion
Time frame: post-treatment, 72 hours
Overnight non-rapid eye movement stage 3 (NREM3) proportion
Time frame: post-treatment, 72 hours
Overnight arousal index (continuity)
Time frame: post-treatment, 72 hours
Daytime sleep duration
Time frame: post-treatment, 72 hours
Daytime REM proportion
Time frame: post-treatment, 72 hours
Daytime NREM3 proportion
Time frame: post-treatment, 72 hours
Daytime arousal index (continuity)
Time frame: post-treatment, 72 hours
Biologic night sleep duration
Time frame: post-treatment, 72 hours
Biologic night REM proportion
Time frame: post-treatment, 72 hours
Biologic night NREM3 proportion
Time frame: post-treatment, 72 hours
Biologic night arousal index (continuity)
Time frame: post-treatment, 72 hours
Atypical sleep
Time frame: post-treatment, 72 hours
Glucose tolerance
Time frame: post-treatment, 72 hours
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 20 May 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.
Melissa P Knauert, MD, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronobundle - light, chronobundle - feeding and chronobundle - mobility in people with Critical Illness and Sleep Deprivation, run by Yale University at 2 sites in United States.
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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Contact Melissa P Knauert, MD, PhD (203-785-4163, melissa.knauert@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian alignment based on diurnal heart rate variation (time frame: post-treatment, 72 hours). 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 20 May 2026.