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

NCT07032441 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-06-24

No results posted yet for this study

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.

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.

Conditions

  • ICU Hospitalization
  • Sleep Deprivation
  • Malnutrition Severe

Interventions

DEVICE

PSG

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07032441 on ClinicalTrials.gov