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NCT Number: NCT07032441

Impact of Sleep Deprivation on Malnutrition in ICU (Intensive Care Unit) Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult ICU patients (≥18 years)
  • Expected length of stay ≥5 days
  • No severe liver or kidney failure (to avoid confounding in nutritional metabolism)

Exclusion criteria

  • Pre-existing malnutrition upon admission (e.g., BMI <18.5 or weight loss >10% within 6 months)
  • Neuromuscular diseases affecting metabolic assessment

Treatment and study plan

PSG

Device

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.

Primary outcomes

  1. Prevalence of malnutrition

    Time frame: From enrollment to the end of treatment at 8 weeks

    NRS-2002

  2. Changes in physiological indicator

    Time frame: From enrollment to the end of treatment at 8 weeks

    Muscle mass

Secondary outcomes

  1. The length of stay (LOS) in ICU

    Time frame: From enrollment to the end of treatment at 8 weeks

    LOS in ICU is a critical metric in healthcare that reflects the duration a patient spends receiving specialized care in an ICU setting.

  2. Incidence of complications

    Time frame: From enrollment to the end of treatment at 8 weeks

    In ICUs, monitoring the incidence of complications is crucial for assessing patient safety, treatment efficacy, and overall healthcare quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Pan Jiang, PHD

CONTACT

[email protected]

18201731016

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Association Between Sleep Deprivation and Malnutrition in Intensive Care Unit Patients: A Prospective Observational Cohort Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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