ICU HospitalizationNCT07032441
Impact of Sleep Deprivation on Malnutrition in ICU (Intensive Care Unit) Patients
An observational study of ICU Hospitalization and Sleep Deprivation, run by Shanghai Zhongshan Hospital.
Trial summary
Study Design This study is a prospective cohort design conducted at Zhongshan Hospital affiliated with Fudan University. It will involve systematic assessments of sleep quality, nutritional status, and associated clinical outcomes in adult ICU patients over a defined observation period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ICU Hospitalization, Sleep Deprivation, Malnutrition Severe
- What is being tested?
- PSG
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2026
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who met the inclusion criteria in the ICU of Zhongshan Hospital, Fudan University from August 2025 were enrolled.
Who may be able to join
- Adult ICU patients (≥18 years)
- Expected length of stay ≥5 days
- No severe liver or kidney failure (to avoid confounding in nutritional metabolism)
Who cannot join
- Pre-existing malnutrition upon admission (e.g., BMI <18.5 or weight loss >10% within 6 months)
- Neuromuscular diseases affecting metabolic assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Sleep Deprivation and Malnutrition in Intensive Care Unit Patients: A Prospective Observational Cohort Study
Study Design This study is a prospective cohort design conducted at Zhongshan Hospital affiliated with Fudan University. It will involve systematic assessments of sleep quality, nutritional status, and associated clinical outcomes in adult ICU patients over a defined observation period.
Sample Size: An estimated 150 adult patients (≥18 years) will be recruited from the ICU.
Read more
Assessments 1. Sleep Quality Assessment:
- Polysomnography (PSG): Sleep quality and duration will be quantified using PSG, which records brain waves, blood oxygen levels, heart rate, and breathing, as well as eye and leg movements. This will provide a comprehensive picture of sleep architecture and disturbances.
- Sleep Quality Index: In addition to PSG data, the Pittsburgh Sleep Quality Index (PSQI) will be administered to assess subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, and daytime dysfunction.
- Nutritional Status Evaluation:
- Nutritional Risk Screening Tools: The Nutritional Risk Screening (NRS-2002) and the Malnutrition Universal Screening Tool (MUST) will be applied to assess nutritional risk and identify malnutrition.
- Biochemical Assessment: Blood samples will be collected to measure biochemical indicators such as serum albumin, transferrin, prealbumin, and other relevant markers of nutritional status.
- Anthropometric Measurements: Body mass index (BMI) and muscle mass assessments will be conducted using bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DEXA) to quantify body composition.
- Physiological Monitoring:
- Continuous monitoring of vital signs, including heart rate, blood pressure, and respiratory rate, will be performed.
- Assessment of immune function through laboratory tests, including white blood cell count and levels of inflammatory markers (C-reactive protein).
- Complications Tracking:
- Data on complications such as infections, delayed wound healing, and respiratory failure will be systematically recorded throughout the ICU stay.
This study aims to elucidate the complex interplay between sleep deprivation and malnutrition in ICU patients. By identifying key associations and influencing factors, we hope to inform targeted clinical interventions that can improve patient care, recovery, and quality of life. The findings will serve as a foundation for future research exploring the intricate relationships between sleep and nutritional status in critical care settings.
- Conditions
- ICU Hospitalization, Sleep Deprivation, Malnutrition Severe
- Being tested
- PSG
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSGDevice
Polysomnography (PSG) is a comprehensive test used to assess sleep disorders and monitor sleep quality. PSG is typically conducted in specialized sleep laboratories and can simultaneously record various physiological parameters to help doctors diagnose different types of sleep disorders, such as obstructive sleep apnea, insomnia, and periodic limb movement disorder.
The monitored components of PSG usually include:
Electroencephalogram (EEG): Records the electrical activity of the brain to determine different sleep stages.
Electrooculogram (EOG): Records eye movements to identify rapid eye movement (REM) sleep stages.
Electromyogram (EMG): Records muscle activity, typically monitoring the muscles of the jaw or legs.
Electrocardiogram (ECG): Monitors the electrical activity of the heart. Respiratory flow monitoring: Records the flow and frequency of breathing. Oxygen saturation monitoring: Monitors blood oxygen levels using a pulse oximeter.
| Study group | Role | What they receive |
|---|---|---|
| SD-ICU | Not described Receives: Device: PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malnutrition
NRS-2002
Measured: From enrollment to the end of treatment at 8 weeks
Changes in physiological indicator
Muscle mass
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
The length of stay (LOS) in ICU
LOS in ICU is a critical metric in healthcare that reflects the duration a patient spends receiving specialized care in an ICU setting.
Measured: From enrollment to the end of treatment at 8 weeks
Incidence of complications
In ICUs, monitoring the incidence of complications is crucial for assessing patient safety, treatment efficacy, and overall healthcare quality.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 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
- NCT07032441
- Sponsor's protocol ID
- SD-ICU-Malnutrition
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sleep Deprivation and Malnutrition in Intensive Care Unit Patients: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07032441
- Acronym / sponsor ID
- SD-ICU-Malnutrition
- Conditions
- ICU Hospitalization, Sleep Deprivation, Malnutrition Severe
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jun 2025 (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.
Study Design This study is a prospective cohort design conducted at Zhongshan Hospital affiliated with Fudan University. It will involve systematic assessments of sleep quality, nutritional status, and associated clinical outcomes in adult ICU patients over a defined observation period.
Sample Size: An estimated 150 adult patients (≥18 years) will be recruited from the ICU.
Assessments 1. Sleep Quality Assessment:
- Polysomnography (PSG): Sleep quality and duration will be quantified using PSG, which records brain waves, blood oxygen levels, heart rate, and breathing, as well as eye and leg movements. This will provide a comprehensive picture of sleep architecture and disturbances.
- Sleep Quality Index: In addition to PSG data, the Pittsburgh Sleep Quality Index (PSQI) will be administered to assess subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, and daytime dysfunction.
- Nutritional Status Evaluation:
- Nutritional Risk Screening Tools: The Nutritional Risk Screening (NRS-2002) and the Malnutrition Universal Screening Tool (MUST) will be applied to assess nutritional risk and identify malnutrition.
- Biochemical Assessment: Blood samples will be collected to measure biochemical indicators such as serum albumin, transferrin, prealbumin, and other relevant markers of nutritional status.
- Anthropometric Measurements: Body mass index (BMI) and muscle mass assessments will be conducted using bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DEXA) to quantify body composition.
- Physiological Monitoring:
- Continuous monitoring of vital signs, including heart rate, blood pressure, and respiratory rate, will be performed.
- Assessment of immune function through laboratory tests, including white blood cell count and levels of inflammatory markers (C-reactive protein).
- Complications Tracking:
- Data on complications such as infections, delayed wound healing, and respiratory failure will be systematically recorded throughout the ICU stay.
This study aims to elucidate the complex interplay between sleep deprivation and malnutrition in ICU patients. By identifying key associations and influencing factors, we hope to inform targeted clinical interventions that can improve patient care, recovery, and quality of life. The findings will serve as a foundation for future research exploring the intricate relationships between sleep and nutritional status in critical care settings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SD-ICU | – | Device: PSG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who met the inclusion criteria in the ICU of Zhongshan Hospital, Fudan University from August 2025 were enrolled.
Key inclusion criteria (3 listed)
- Adult ICU patients (≥18 years)
- Expected length of stay ≥5 days
- No severe liver or kidney failure (to avoid confounding in nutritional metabolism)
Key exclusion criteria (2 listed)
- Pre-existing malnutrition upon admission (e.g., BMI <18.5 or weight loss >10% within 6 months)
- Neuromuscular diseases affecting metabolic assessment
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 |
|---|---|---|
| PSGPolysomnography (PSG) is a comprehensive test used to assess sleep disorders and monitor sleep quality. PSG is typically conducted in specialized sleep laboratories and can simultaneously record various physiological parameters to help doctors diagnose different types of sleep disorders, such as obstructive sleep apnea, insomnia, and periodic limb movement disorder. The monitored components of PSG usually include: Electroencephalogram (EEG): Records the electrical activity of the brain to determine different sleep stages. Electrooculogram (EOG): Records eye movements to identify rapid eye movement (REM) sleep stages. Electromyogram (EMG): Records muscle activity, typically monitoring the muscles of the jaw or legs. Electrocardiogram (ECG): Monitors the electrical activity of the heart. Respiratory flow monitoring: Records the flow and frequency of breathing. Oxygen saturation monitoring: Monitors blood oxygen levels using a pulse oximeter. | Device | SD-ICU |
Primary outcome
Prevalence of malnutrition
Time frame: From enrollment to the end of treatment at 8 weeks
NRS-2002
Changes in physiological indicator
Time frame: From enrollment to the end of treatment at 8 weeks
Muscle mass
2 secondary outcomes
The length of stay (LOS) in ICU
Time frame: From enrollment to the end of treatment at 8 weeks
Incidence of complications
Time frame: From enrollment to the end of treatment at 8 weeks
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 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Hospitalization and Sleep Deprivation, run by Shanghai Zhongshan Hospital.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Pan Jiang, PHD (18201731016, jiang.pan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malnutrition (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 2 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 24 Jun 2025.