Impact of Sleep Deprivation on Malnutrition in ICU (Intensive Care Unit) Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital
About this trial
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:
1. 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. 2. 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.
2\. Nutritional Status Evaluation:
1. 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. 2. Biochemical Assessment: Blood samples will be collected to measure biochemical indicators such as serum albumin, transferrin, prealbumin, and other relevant markers of nutritional status. 3. 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.
3\. Physiological Monitoring:
1. Continuous monitoring of vital signs, including heart rate, blood pressure, and respiratory rate, will be performed. 2. Assessment of immune function through laboratory tests, including white blood cell count and levels of inflammatory markers (C-reactive protein).
4\. Complications Tracking:
1\. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult ICU patients (≥18 years)
Expected length of stay ≥5 days
No severe liver or kidney failure (to avoid confounding in nutritional metabolism)
Disqualifiers
Pre-existing malnutrition upon admission (e.g., BMI <18.5 or weight loss >10% within 6 months)
Neuromuscular diseases affecting metabolic assessment
Trial population
Patients who met the inclusion criteria in the ICU of Zhongshan Hospital, Fudan University from August 2025 were enrolled.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
PSG
DevicePolysomnography (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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: SD-ICU1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of malnutrition
NRS-2002
Time frame
From enrollment to the end of treatment at 8 weeks2
Changes in physiological indicator
Muscle mass
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 8 weeks2
Incidence of complications
In ICUs, monitoring the incidence of complications is crucial for assessing patient safety, treatment efficacy, and overall healthcare quality.
Time frame
From enrollment to the end of treatment at 8 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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