What this Trial Is About

Delirium is a common and serious condition affecting older adults in hospitals, especially those aged 65 and above. It involves sudden changes in consciousness, attention, and thinking, often fluctuating in severity. This condition is linked to longer hospital stays, higher healthcare costs, increased risk of dementia, and greater chances of discharge to long-term care. Due to its complexity and the limited effectiveness of current treatments, new preventive strategies are needed. Melatonin, a hormone that regulates the sleep-wake cycle, is being studied for its potential to prevent delirium, as sleep disruption is closely related to delirium development. This study compares two doses of melatonin, 5 mg/day and 8 mg/day, to a placebo in older patients hospitalized in general medical wards. The trial is randomized, double-blinded, and placebo-controlled, aiming to provide strong evidence on whether melatonin can reduce the occurrence of delirium in this population. Melatonin is given daily, and the study addresses previous limitations such as small sample sizes and low doses used in earlier research. Participants will be monitored for the occurrence of delirium over five days. Researchers will assess cognitive function, attention, and sleep patterns, alongside safety measures such as liver function tests and medication adherence. The study will also evaluate any side effects and the overall impact of melatonin on patients' hospital experience. The trial's duration and detailed follow-up will help determine melatonin's effectiveness and safety in preventing delirium among elderly hospitalized patients.

The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients