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The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients
Sponsor: Sultan Qaboos University
Summary
The high prevalence of delirium in hospitalized older adults, with significant associated morbidity and mortality, emphasize the need for effective prevention strategies. Limited trials have explored melatonin's potential in preventing delirium among patients admitted to general medical wards. Previous trials on melatonin's preventive role in medical wards had limitations, necessitating a robust, double-blinded, placebo-controlled design with a larger sample size. This randomized, double-blind study of melatonin versus placebo aims to investigate the efficacy of melatonin, a neurohormone regulating the sleep-wake cycle, in preventing delirium among medically hospitalized patients aged 65 or older. Given the high prevalence of delirium in this population and its association with adverse outcomes, the study seeks to contribute valuable insights into an effective preventive strategy.
Official title: Effect of Melatonin Versus Placebo for Prevention of Delirium Among Medically Hospitalized Patients: Study Protocol for a Single-Center, Double-Blinded, Randomised Controlled Trial
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-09-30
Completion Date
2025-06
Last Updated
2025-01-14
Healthy Volunteers
No
Conditions
Interventions
Intervention 1
Melatonin 5mg/day
Intervention 2
Melatonin 8 mg/day
Control
Placebo
Locations (2)
Sultan Qaboos University Hospital
Muscat, Oman
Sultan Qaboos University Hospital
Muscat, Oman