SleepEarly Phase 1ALIGN ICUNCT07886567
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
A Early Phase 1 study testing Sleep chronobundle in people with Sleep and Circadian Dysregulation, run by University of Alberta at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Circadian Dysregulation, ICU
- What is being tested?
- Sleep chronobundle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2026to 1 Jan 2029
- Phase
- Early Phase 1
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
- Age 18 years or older.
- Admission to a participating ICU.
- Expected ICU stay of at least 48 hours.
- Respiratory failure requiring invasive mechanical ventilation, non-invasive ventilation, or high-flow oxygen therapy, or shock requiring vasopressor therapy.
- Receipt of intermittent or continuous sedation.
Who cannot join
- Comfort-focused care or anticipated death.
- Severe chronic neurologic disability.
- Acute brain injury.
- Known circadian rhythm disorder.
- Blindness or optic nerve disease.
- Contraindication to the daytime feeding schedule.
- Acute drug overdose.
- Active alcohol withdrawal syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University Alberta Hospital
Edmonton, Alberta, T6G2B7
Elizabeth Wilcox, 780-407-3028, elizabeth.wilcox@albertahealthservices.ca
About this study
Official title: ALIGN ICU: reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Sleep, Circadian Dysregulation, ICU, Delirium in Intensive Care Unit
- Being tested
- Sleep chronobundle, Control
- Keywords
- sleep, circadian dysregulation, chronobundle, sleep hygiene, delirium
- Medical subject headings
- Chronobiology Disorders, Sleep Hygiene, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep chronobundleCombination product
Also called Bright light therapy, Scheduled intermittent feeding, Daily mobility, Overnight sleep promotion
Participants in the intervention arm will receive usual ICU care plus a multifaceted sleep chronobundle comprising:
- Bright light therapy at 10,000 lux daily 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, adapted to clinical condition.
- 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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention (Sleep Chronobundle) Receives: Combination Product: Sleep chronobundle |
| Control | Placebo comparator | Standard of Care Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This multicentre pilot trial uses a randomized, parallel-group design. Approximately 100 participants across eight Canadian ICUs will be assigned in a 1:1 ratio to a multifaceted sleep chronobundle or usual ICU care. Randomization will use a centralized web-based REDCap system with variable block sizes and a concealed allocation sequence. Participants will remain in their assigned group throughout the study, with no planned crossover. The intervention will be delivered for seven days, extending to up to 10 days at investigator discretion, and will continue on the ward to complete seven days if ICU discharge occurs earlier. Both groups will undergo the same study assessments, including follow-up at 90 and 180 days. The pilot is designed to establish feasibility and inform a larger efficacy trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886567
- Sponsor's protocol ID
- Pro00167567
- Acronym
- ALIGN ICU
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.