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

NCT ID: NCT07032441

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

SD-ICU

PSG

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pan Jiang, PHD

Role: CONTACT

jiang.pan@zs-hospital.sh.cn

18201731016

Other Identifiers

SD-ICU-Malnutrition

Identifier Type: -

Identifier Source: org_study_id