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reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sponsor: University of Alberta
Summary
The goal of this pilot clinical trial is to learn whether a program to support sleep and the body's daily rhythms can be delivered safely and consistently to critically ill adults in intensive care units (ICUs). These rhythms help control when people feel awake or sleepy and can become disrupted during critical illness. The main questions it aims to answer are: Can enough participants be enrolled, and can ICU teams consistently deliver the program? Is the program acceptable to participants and care teams? What preliminary effects does the program have on sleep, daily rhythms, delirium (a sudden change in thinking that causes confusion), and recovery? Researchers will compare the sleep program with usual ICU care. Participants will be assigned by chance to one of these two groups. Findings will help researchers plan a larger trial. Participants will: Receive usual ICU care or the sleep program for 7 days, with treatment extended to up to 10 days when appropriate. If assigned to the sleep program, receive bright light in the morning, tube feeding at scheduled daytime and evening times, daily movement or exercise as their condition allows, and care that reduces unnecessary nighttime interruptions. Have sleep monitored using a portable recording device and undergo daily assessments for delirium. Answer questions about sleep and their experience of the study when able. Complete telephone assessments of memory, thinking, and sleep quality approximately 3 and 6 months after enrolment.
Official title: ALIGN ICU: reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-11-30
Completion Date
2029-01-01
Last Updated
2026-10-21
Healthy Volunteers
No
Interventions
Sleep chronobundle
Participants in the intervention arm will receive usual ICU care plus a multifaceted sleep chronobundle comprising: 1. Bright light therapy at 10,000 lux daily from 09:00 to 13:00. 2. Scheduled enteral feeding at 08:00, 12:00, 16:00, and 20:00. 3. One daily mobility or exercise session between 09:00 and 15:59, adapted to clinical condition. 4. Overnight sleep promotion from 22:00 to 06:00, including protected sleep from 00:00 to 04:00, with non-urgent care rescheduled when clinically appropriate. The intervention will be delivered for seven days, extending to up to 10 days at investigator discretion. If ICU discharge occurs before day seven, it will continue on the ward to complete seven days. Components may be modified or withheld for clinical reasons, with deviations and their rationale documented.
Control
Participants in the control arm will receive usual ICU care according to local clinical practices, including routine management of nutrition, mobility, sleep, sedation, and delirium. Study personnel will not provide prompts to implement the sleep chronobundle. Clinically indicated care will remain at the discretion of the treating team. Control participants will undergo the same study assessments and follow-up as those in the intervention arm.
Locations (1)
University Alberta Hospital
Edmonton, Alberta, Canada