reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit

NCT07886567 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Pro00167567
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep; Circadian Dysregulation; ICU; Delirium in Intensive Care Unit

Keywords

sleep; circadian dysregulation; chronobundle; sleep hygiene; delirium

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention (Sleep Chronobundle)

Combination Product: Sleep chronobundle

Control

PLACEBO COMPARATOR

Standard of Care

Other: Control

Interventions

Control OTHER

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.

Control

Sleep chronobundle COMBINATION_PRODUCT

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• University Hospital Foundation: collaborator

Study Sites (1)

University Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

Chronobiology Disorders; Sleep Hygiene; Delirium

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Health Behavior; Behavior; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Central Study Contacts

Elizabeth Wilcox, MD PhD

CONTACT

780-407-3028; mwilcox@ualberta.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No additional parties are masked. Participants and treating clinicians are aware of group assignment because the intervention involves visible changes to bedside care. Research personnel responsible for screening and enrolment cannot access the randomization sequence before allocation; this represents allocation concealment rather than masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

CA (1)