An interventional study of Sound and Light Optimization and Night-time Patient Care Activities in ICU Hospitalization, Circadian Rhythm and Sleep Deprivation, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Supportive care
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.
Circadian rhythm intervention is a growing research field in critical care. The ICU environment is complTex, and circadian disruption is influenced by many risk factors. Studies have shown that single interventions have limited effects on improving clinical outcomes. Therefore, a multicomponent approach targeting multiple risk factors may be more effective in improving sleep and circadian regulation in ICU patients. Previous studies have often focused only on subjective sleep quality and ignored objective circadian measures such as hormone secretion rhythms and sleep-wake cycles. This limits the reliability of their findings.
This study develops a multicomponent sleep and circadian rhythm intervention that includes sound and light control, optimization of nursing activities, promotion of daytime activity, and cognitive stimulation. Subjective and objective measures will be used to evaluate sleep and circadian rhythm. The study is a non-randomized controlled trial designed to test the feasibility of this intervention and to explore its preliminary effects in ICU patients.
308 studies on the registry are indexed under Sleep Deprivation; 62 are open to participants now.
This study's planned enrollment of 70 is above the median of 44 across 253 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.
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Exclusion Criteria:
This intervention includes sound and light optimization, night-time patient care activities adjustment, enhanced daytime mobility, cognitive stimulation
Other: Sound and Light Optimization · Other: Night-time Patient Care Activities · Other: Enhanced Daytime Mobility · Other: Cognitive Stimulation
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.
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.
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.
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.
Recruitment rate
Percentage of eligible patients who provide informed consent and enroll in the study
Time frame: From enrollment to Day 3
Retention rate through Day 3
Percentage of enrolled participants who remain in the study through Day 3
Time frame: From enrollment to Day 3
Data completeness
Percentage of required study data that are missing
Time frame: From enrollment to Day 3
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
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
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
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
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.
N3 sleep stage percentage
Overnight polysomnography (PSG) will be performed to objectively assess sleep. N3 sleep stage percentage will be derived from overnight polysomnography.
Time frame: During the second night following ICU admission.
REM sleep stage percentage
Overnight polysomnography (PSG) will be performed to objectively assess sleep.REM sleep stage percentage, will be derived from overnight polysomnography.
Time frame: During the second night following ICU admission
Mean activity level measured by wrist actigraphy
Physical activity will be continuously assessed using a wrist-worn actigraphy device. Mean activity level will be calculated separately for daytime and nighttime periods.
Time frame: During Days 1 and 2 of the ICU stay.
Rate of non-zero activity measured by wrist actigraphy
The rate of non-zero activity will be assessed using a wrist-worn actigraphy device and defined as the percentage of valid epochs with activity counts greater than zero, calculated separately for daytime and nighttime periods.
Time frame: During Days 1 and 2 of the ICU stay.
Mean non-zero activity intensity measured by wrist actigraphy
Mean non-zero activity intensity will be assessed using a wrist-worn actigraphy device and expressed as the mean activity counts among epochs with activity counts greater than zero, calculated separately for daytime and nighttime periods.
Time frame: During Days 1 and 2 of the ICU stay.
Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 10 months after the start.
Of 142 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 10 months is below that.
Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 8 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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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