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Sleep and Circadian Rhythm Intervention in ICU

ConditionsICU HospitalizationCircadian RhythmSleep Deprivation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18 years or older.

Patients expected to stay in the surgical ICU for at least 2 nights.

Patients directly admitted to the surgical ICU postoperatively.

Patients with a Richmond Agitation-Sedation Scale (RASS) score between -1 and 1 upon ICU admission.

Disqualifiers

Patients who have delirium or dementia at ICU admission.

Patients who are unable to communicate effectively.

Patients with hearing or vision impairment.

Patients with lower-limb deep vein thrombosis, fractures, or multiple severe injuries that contraindicate early mobilization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sound and Light Optimization

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Multiplecomponent sleep and circadian rhythm interventionExperimental treatment 4 interventions
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

Percentage of eligible patients who provide informed consent and enroll in the study

Time frame
From enrollment to Day 3
2

Retention rate through Day 3

Percentage of enrolled participants who remain in the study through Day 3

Time frame
From enrollment to Day 3
3

Data completeness

Percentage of required study data that are missing

Time frame
From enrollment to Day 3
4

Intervention adherence

Percentage of participants allocated to the intervention group who receive the complete intervention as planned up to ICU discharge

Time frame
From enrollment to Day 3

Secondary outcomes

1

Melatonin concentration

Serum melatonin concentrations will be measured to characterize melatonin secretion and its temporal pattern. Melatonin concentrations will be quantified using liquid chromatography-mass spectrometry (LC-MS).

Time frame
Blood samples will be collected at 03:00, 15:00 in the first three days after ICU admission
2

Cortisol concentration

Serum cortisol concentrations will be measured to characterize cortisol secretion and its temporal pattern.

Time frame
Blood samples will be collected at 03:00 and 15:00 in the first three days after ICU admission
3

Richards-Campbell Sleep Questionnaire score

Subjective sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ evaluates perceived nighttime sleep, including sleep depth, sleep latency, awakenings, return to sleep, and overall sleep quality. The total score ranges from 0 to 100, with higher scores indicating better perceived sleep quality.

Time frame
Each mornining the first three days after ICU admission
4

Total sleep time measured by polysomnography

Overnight polysomnography (PSG) will be performed to objectively assess sleep. Total sleep time, expressed in minutes, will be derived from overnight polysomnography.

Time frame
During the second night following ICU admission.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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