Sleep and Circadian Rhythm Intervention in ICU

Condition(s) studied

Investigational drug(s) / intervention(s)

Sound and Light Optimization: Patients receive eye masks and earplugs at night; Overhead lights are turned off at 10:00 p.m. and replaced with dim bedside lights until 7:00 a.m; Curtains are opened as early as possible after 7:00 a.m; Device alarms and telephones are set to low volume during the night and restored to normal levels after 7:00 a.m; Staff members switch their phones to silent or vibration mode and keep conversations at low volume; A noise meter is installed to remind staff to maintain a quiet environment.

Night-time Patient Care Activities: Nighttime care activities will be reorganized to reduce patient disturbances. Non-urgent procedures will be postponed to daytime hours, while emergency interventions will proceed as needed.

Enhanced Daytime Mobility: Additional early mobilization sessions led by a physiotherapist will be conducted once daily between 10:00 and 16:00 during ICU stay, including out-of-bed and limb exercises. The intensity will be individualized according to the patient's clinical condition.

Cognitive Stimulation: Patients will receive daily orientation to time and environment to reinforce temporal and spatial awareness. Daytime interaction with patients will be encouraged to promote alertness and assess comfort and sleep quality. For nonverbal patients, visual aids such as picture cards or writing boards will be provided to facilitate communication. Simple entertainment tools (e.g., radio, rehabilitation ball) will be offered to promote wakefulness during the daytime.

Study summary

Intensive care unit (ICU) patients are frequently exposed to various stressors that contribute to severe sleep disruption and circadian rhythm disturbances. Growing evidence suggests that circadian rhythm disruption plays a critical role in the development of multiple adverse outcomes in critically ill patients. Therefore, implementing interventions that prioritize the maintenance of normal circadian, sleep, and behavioral patterns may represent an important strategy to improve outcomes in ICU patients.

Eligibility

Primary outcome measure(s)

• Recruitment rate — From enrollment to Day 3
  Percentage of eligible patients who provide informed consent and enroll in the study
• Retention rate through Day 3 — From enrollment to Day 3
  Percentage of enrolled participants who remain in the study through Day 3
• Data completeness — From enrollment to Day 3
  Percentage of required study data that are missing
• Intervention adherence — From enrollment to Day 3
  Percentage of participants allocated to the intervention group who receive the complete intervention as planned up to ICU discharge

Trial sites (1)

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