An Early Phase 1 interventional study of Sleep chronobundle and Control in Sleep, Circadian Dysregulation and ICU, sponsored by University of Alberta. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Alberta · Early Phase 1, Interventional, and Treatment
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.
ALIGN-ICU is a prospective, multicentre, parallel-group pilot randomized controlled trial evaluating the implementation of a multifaceted sleep chronobundle within routine critical care workflows. The intervention combines circadian entrainment strategies with overnight sleep promotion to address both daytime and nighttime contributors to sleep and circadian disruption.
Critical illness can disrupt circadian physiology through abnormal light exposure, irregular feeding and activity patterns, sedative administration, and frequent nighttime care interruptions. Existing sleep-promotion approaches predominantly address the nighttime environment. ALIGN-ICU integrates daytime environmental and behavioural cues with nighttime sleep protection, with the rationale that coordinated delivery may better support circadian alignment than individual components alone.
The chronobundle comprises bright light exposure at 10,000 lux from 09:00 to 13:00; scheduled enteral feeding at 08:00, 12:00, 16:00, and 20:00; one daily mobility or exercise session between 09:00 and 15:59; and overnight sleep promotion from 22:00 to 06:00, including a protected sleep period from 00:00 to 04:00. Non-urgent care activities will be rescheduled when clinically appropriate. Intervention delivery will accommodate patient-specific clinical needs, with modifications, withheld components, and reasons for deviations documented. Treatment will continue on the ward to complete seven days when ICU discharge occurs earlier.
Allocation will be performed through a centralized REDCap randomization system using variable block sizes. Because the intervention involves visible changes to bedside care, implementation will emphasize standardized delivery across participating centres. Sites will receive training, implementation manuals, bedside checklists, and quick-reference materials. Local clinical champions and designated research coordinators will support delivery, troubleshoot barriers, and reinforce adherence. Prospective documentation, regular audits, and feedback to sites will inform assessment of intervention fidelity and opportunities for refinement.
The pilot will characterize recruitment processes, delivery within competing clinical workflows, and participant and clinician adherence. Participant feedback near hospital discharge will explore the acceptability, appropriateness, and duration of individual intervention components and study procedures. Portable polysomnography and physiological circadian measures will provide complementary information about sleep and biological responses.
Analyses will be primarily descriptive. Clinical and biological estimates will be reported with measures of uncertainty; no formal efficacy hypothesis testing is planned. Findings will guide intervention refinement, implementation procedures, and the design of a subsequent adequately powered multicentre efficacy trial.
92 studies on the registry are indexed under Chronobiology Disorders; 22 are open to participants now.
This study's planned enrollment of 50 is below the median of 61 across 60 interventional studies indexed under Chronobiology Disorders.
Browse Chronobiology Disorders studies →University of Alberta is the lead sponsor of 819 studies on the registry; 168 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
Intervention (Sleep Chronobundle)
Combination Product: Sleep chronobundle
Standard of Care
Other: Control
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.
Also known as: Bright light therapy, Scheduled intermittent feeding, Daily mobility, Overnight sleep promotion
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.
Recruitment rate
The primary outcome is feasibility of conducting the trial and implementing the sleep chronobundle, assessed by recruitment rate, consent rate, time from eligibility to randomization, and protocol adherence. Feasibility targets are recruitment of at least one participant per site per month, consent from more than 50% of eligible participants approached, and adherence to at least 75% of prescribed intervention components. Delivery of each component and reasons for missed or modified delivery will be documented prospectively.
Time frame: 2 years
Plan to share: Yes — De-identified individual participant data underlying the published DELDEX pilot results will be shared upon reasonable request, including participant characteristics, treatment allocation, feasibility, sleep, delirium, clinical and safety outcomes, with a data dictionary, study protocol and statistical analysis plan. Data will be available from 12 months after publication of the primary results for five years. Qualified researchers must submit a methodologically sound proposal to the principal investigator describing the research question, requested data, analyses and secure data-handling arrangements. Access requires principal investigator and Steering Committee approval, ethics approval or exemption where applicable, and a signed institutional data-sharing agreement prohibiting re-identification and unauthorized onward sharing. Data will be provided securely, consistent with participant consent, ethics approvals and institutional requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: De-identified IPD and supporting information will be available beginning 12 months after publication of the primary DELDEX pilot trial results and for five years thereafter.
Access criteria: Qualified researchers may request de-identified IPD underlying the published results, a data dictionary, the study protocol and SAP for verification, secondary analyses or IPD meta-analyses. Requests must be submitted to the principal investigator using the contact details in the trial record and include the research question, requested data, analysis plan and secure data-handling arrangements. Access requires approval by the principal investigator and Steering Committee, research ethics approval or exemption where applicable, and a signed institutional data-sharing agreement prohibiting re-identification and unauthorized onward sharing. Approved materials will be provided through secure institutional transfer or access, consistent with participant consent, ethics approvals and institutional requirements.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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