ICU HospitalizationNCT07869901
Sleep and Circadian Rhythm Intervention in ICU
A study testing Sound and Light Optimization, Night-time Patient Care Activities and Enhanced Daytime Mobility in people with ICU Hospitalization and Circadian Rhythm, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Hospitalization, Circadian Rhythm, Sleep Deprivation
- What is being tested?
- Sound and Light Optimization, Night-time Patient Care Activities and Enhanced Daytime Mobility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
- Patients after cranial or otolaryngological surgery who cannot use earplugs or eye masks.
- Patients with a history of dementia, psychiatric disorders, or structural neurological diseases.
- Pregnant or breastfeeding patients.
- Patients in a terminal or end-of-life condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital Fudan University, Shanghai
Shanghai, Shanghai Municipality, 200032
Yuxia Zhang, +86 19921875401, tyguan12@163.com
About this study
Official title: Feasibility Study of a Multicomponent Sleep and Circadian Rhythm Intervention in Surgical Intensive Care Unit Patients
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.
Read the detailed description
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.
- Conditions
- ICU Hospitalization, Circadian Rhythm, Sleep Deprivation
- Being tested
- Sound and Light Optimization, Night-time Patient Care Activities, Enhanced Daytime Mobility, Cognitive Stimulation
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound and Light OptimizationOther
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 ActivitiesOther
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 MobilityOther
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 StimulationOther
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 group | Role | What they receive |
|---|---|---|
| Multiplecomponent sleep and circadian rhythm intervention | Experimental | This intervention includes sound and light optimization, night-time patient care activities adjustment, enhanced daytime mobility, cognitive stimulation Receives: Other: Sound and Light Optimization; Other: Night-time Patient Care Activities; Other: Enhanced Daytime Mobility; Other: Cognitive Stimulation |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Percentage of eligible patients who provide informed consent and enroll in the study
Measured: From enrollment to Day 3
Retention rate through Day 3
Percentage of enrolled participants who remain in the study through Day 3
Measured: From enrollment to Day 3
Data completeness
Percentage of required study data that are missing
Measured: 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
Measured: From enrollment to Day 3
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During Days 1 and 2 of the ICU stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Aug 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU HospitalizationStudies 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869901
- Sponsor's protocol ID
- Zs-SyNC-study
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Multicomponent Sleep and Circadian Rhythm Intervention in Surgical Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07869901
- Acronym / sponsor ID
- Zs-SyNC-study
- Conditions
- ICU Hospitalization, Circadian Rhythm, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiplecomponent sleep and circadian rhythm intervention | Experimental | Other: Sound and Light Optimization, Other: Night-time Patient Care Activities, Other: Enhanced Daytime Mobility, Other: Cognitive StimulationThis intervention includes sound and light optimization, night-time patient care activities adjustment, enhanced daytime mobility, cognitive stimulation |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Patients after cranial or otolaryngological surgery who cannot use earplugs or eye masks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound and Light OptimizationPatients 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. | Other | Multiplecomponent sleep and circadian rhythm intervention |
| Night-time Patient Care ActivitiesNighttime 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. | Other | Multiplecomponent sleep and circadian rhythm intervention |
| Enhanced Daytime MobilityAdditional 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. | Other | Multiplecomponent sleep and circadian rhythm intervention |
| Cognitive StimulationPatients 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. | Other | Multiplecomponent sleep and circadian rhythm intervention |
Primary outcome
Recruitment rate
Time frame: From enrollment to Day 3
Percentage of eligible patients who provide informed consent and enroll in the study
Retention rate through Day 3
Time frame: From enrollment to Day 3
Percentage of enrolled participants who remain in the study through Day 3
Data completeness
Time frame: From enrollment to Day 3
Percentage of required study data that are missing
Intervention adherence
Time frame: From enrollment to Day 3
Percentage of participants allocated to the intervention group who receive the complete intervention as planned up to ICU discharge
9 secondary outcomes
Melatonin concentration
Time frame: Blood samples will be collected at 03:00, 15:00 in the first three days after ICU admission
Cortisol concentration
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
Time frame: Each mornining the first three days after ICU admission
Total sleep time measured by polysomnography
Time frame: During the second night following ICU admission.
N3 sleep stage percentage
Time frame: During the second night following ICU admission.
REM sleep stage percentage
Time frame: During the second night following ICU admission
Mean activity level measured by wrist actigraphy
Time frame: During Days 1 and 2 of the ICU stay.
Rate of non-zero activity measured by wrist actigraphy
Time frame: During Days 1 and 2 of the ICU stay.
Mean non-zero activity intensity measured by wrist actigraphy
Time frame: During Days 1 and 2 of the ICU stay.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound and Light Optimization, Night-time Patient Care Activities and Enhanced Daytime Mobility in people with ICU Hospitalization and Circadian Rhythm, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From enrollment to Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.