An interventional study of Chronobundle - light and chronobundle - feeding in Critical Illness, Sleep Deprivation and Circadian Rhythm Sleep Disorder, Unspecified, sponsored by Yale University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
Among 146 studies in Sleep Deprivation with a site in United States — 30 open to participants now, 35 under way, none of them phase 3. Sleep Deprivation · United States.
Among the 146 studies in Sleep Deprivation with a site in United States, this one is the 20th largest by planned enrollment of the 127 interventional ones, is one of 12 that started in 2024, is one of 104 with no phase, reaches primary completion later than 31 of the 34 other live ones, and was the 107th registered.
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
This study's planned enrollment of 160 is above the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →30 of the 146 studies in Sleep Deprivation with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 43 Sleep Deprivation studies recruiting now, 11 (26%) set no upper age limit and 28 (65%) stop at 75 or younger; 5 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →146 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 12 started in 2024.
Median enrollment 56 across the 127 interventional studies, 64 across the 19 observational. Of the 106 that completed or were terminated, 27 (25%) have results posted.
13 of 146 have an industry lead sponsor. The 10 most frequent:
Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Yale University has 3 studies filed under Sleep Deprivation — fewer than ten, so there is no comparison to draw.
7 of the studies in Sleep Deprivation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06642246Children's Hospital of PhiladelphiaSleep Promotion and Pediatric Hypertension | 2026-11 |
| NCT06336525Brigham and Women's HospitalAdult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities. | 2027-01-31 |
| NCT05393830Beth Israel Deaconess Medical CenterThe Effect of Sleep Loss on Emotion Regulation | 2027-04-01 |
| NCT05703347Children's Hospital of PhiladelphiaOptimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children | 2027-06 |
| NCT02945501U.S. Army Medical Research and Development CommandTranscranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep | 2027-06 |
Among the 146 studies in Sleep Deprivation with a site in United States, from their registry updates:
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.
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.
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
This study's planned enrollment of 160 is above the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Compared within Sleep Deprivation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion:
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 , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual ICU care.
The chronobundle will include bright daytime light, time-restricted intermittent feeding, enhanced exercise/mobility, and overnight sleep promotion.
Other: Chronobundle - light · Other: chronobundle - feeding · Other: chronobundle - mobility · Other: chronobundle - sleep
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.
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.
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.
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.
Circadian alignment based on diurnal heart rate variation
Individual heart rate nadir compared to population normal nadir of 04:00. Maximum difference +/- 12 hours.
Time frame: post-treatment, 72 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: post-treatment, 72 hours
Daytime sleep duration
Minutes of sleep from 06:00 to 21:59 as measured by NoxA1 portable polysomnography device.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: post-treatment, 72 hours
Glucose tolerance
Area under the curve per 24 hour period of continuous glucose monitoring.
Time frame: post-treatment, 72 hours
Exploratory - Days without Delirium or Coma
Days alive and without delirium or coma out of the 14 days post randomization
Time frame: post-treatment, 14 days post randomization
Exploratory - Ventilator Free Days
Days alive and ventilator free out of 28 days post-randomization.
Time frame: post-treatment, 28 days post randomization
Exploratory - Time to ICU Discharge
Days to ICU discharge post-randomization.
Time frame: post-treatment
Exploratory - Time to Hospital Discharge
Days to hospital discharge post-randomization.
Time frame: post-treatment
Exploratory - Mortality
Mortality at 30 days post-randomization.
Time frame: post-treatment, 30 days post-randomization
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Jun 2029, 61 months after the start.
Of 141 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 61 months is above that.
Counting every sponsor, half of 150 studies reached it within 17 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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