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Not yet recruiting NCT07032441

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

Observational ICU Hospitalization Sleep Deprivation Malnutrition Severe

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PSG.
Who it may be relevant to
Registry conditions: ICU Hospitalization, Sleep Deprivation, Malnutrition Severe. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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 dete

Primary outcome measures

  • Prevalence of malnutrition [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Changes in physiological indicator [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07032441 · SD-ICU-Malnutrition

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗