Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062320) titled 'Association of Intracerebral Neurotoxic Substances with ICU Delirium and Sleep Disturbances in Critically Ill Patients' on Oct. 1.

Study Type: Observational

Primary Sponsor: Institute - Tokushima University

Condition: Condition - critically ill patients in the ICU Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - We designed a clinical study to investigate the relationship between the development of ICU-acquired delirium (ICU-AD), a condition that worsens the prognosis of critically ill patients, and the neurotoxic brain proteins amyloid beta (AB) and Tau. ICU-AD is associated with prolonged ICU stays, increased medical costs, higher in-hospital mortality rates, and cognitive impairment following ICU discharge. AB and Tau are metabolic waste products synthesized in the brain that are normally cleared during sleep. However, their accumulation exerts neurotoxic effects and contributes to the development of dementia and Alzheimer's disease. Recent studies have shown that AB accumulates in the brain even after short-term sleep disruption and can trigger perioperative delirium. Given that over 90% of ICU patients experience sleep disturbances, such disturbances are hypothesized to be a risk factor for ICU-AD; however, no research has yet examined the links between delirium onset and AB/Tau levels, or between sleep dynamics and AB/Tau concentrations in this patient population. The objective of this study is to evaluate, using objective sleep data, whether sleep disturbances in ICU patients induce the accumulation of AB and Tau and contribute to the onset of delirium. Basic objectives2 - Bio-equivalence

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adult patients aged 18 years or older receiving treatment in the ICU who are capable of communication and are expected to have an ICU stay exceeding 72 hours. Key exclusion criteria - Patients with a high probability of death within 72 hours of ICU admission Patients with intracranial disorders (e.g., cerebral infarction, cerebral hemorrhage, head trauma, post-brain tumor resection) Pediatric patients under 18 years of age Pregnant or postpartum women Patients with a history of epilepsy or status epilepticus Patients with severe dementia Patients with sleep disorders or sleep apnea Patients with a history of delirium Patients in a persistent coma since admission, making sleep assessment impossible Patients for whom simplified polysomnography cannot be performed (e.g., due to forehead wounds or the attachment of other monitoring devices) Patients resuscitated after cardiopulmonary arrest Patients with severe anemia (Hb <7.0 g/dL) or hemorrhagic shock Other patients deemed unsuitable by the attending physician. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071319

Disclaimer: Curated by HT Syndication.