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

NCT07032441 | Not Yet Recruiting DMC

• 1 other identifier: SD-ICU-Malnutrition
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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. 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. 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.
3. 3.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.
4. 4.Biochemical Assessment: Blood samples will be collected to measure biochemical indicators such as serum albumin, transferrin, prealbumin, and other relevant markers of nutritional status.
5. 5.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.
6. 6.Continuous monitoring of vital signs, including heart rate, blood pressure, and respiratory rate, will be performed.
7. 7.Assessment of immune function through laboratory tests, including white blood cell count and levels of inflammatory markers (C-reactive protein).

Conditions

ICU Hospitalization; Sleep Deprivation; Malnutrition Severe

Outcome Measures

Primary Outcomes (2)

• Prevalence of malnutrition

  NRS-2002

  From enrollment to the end of treatment at 8 weeks

• Changes in physiological indicator

  Muscle mass

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

• The length of stay (LOS) in ICU

  From enrollment to the end of treatment at 8 weeks

• Incidence of complications

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

SD-ICU

Device: PSG

Interventions

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.

SD-ICU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who met the inclusion criteria in the ICU of Zhongshan Hospital, Fudan University from August 2025 were enrolled.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Pan Jiang, PHD

CONTACT

18201731016; jiang.pan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share