Actively Recruiting
The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients
Led by Sultan Qaboos University · Updated on 2025-01-14
240
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit
You will not qualify if you...
- Patients requiring vasopressors or non-invasive ventilation
- Admission through emergency to Intensive Care Unit or High Dependency Unit
- Aphasic patients
- Patients with language barriers
- Taking melatonin or ramelteon at time of randomization
- Presence of delirium at time of randomization
- Contraindication to enteral medications due to gastrointestinal conditions
- Lack of nasogastric tube when enteral medications are needed
- Alanine aminotransferase or aspartate aminotransferase levels more than 3 times upper limit of normal
- Use of strong cytochrome P450 1A2 inhibitors such as fluvoxamine and viloxazine
- Active alcohol drinking or admission with alcohol withdrawal syndrome
- Unable to provide informed consent within 24 hours of admission
- Autoimmune diseases including rheumatoid arthritis, inflammatory bowel disease, and systemic lupus erythematosus
- Allergy to melatonin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Sultan Qaboos University Hospital
Muscat, Oman, 123
Not Yet Recruiting
2
Sultan Qaboos University Hospital
Muscat, Oman, 123
Actively Recruiting
Research Team
A
Abdullah M Al Alawi, FRACP
CONTACT
J
Juhaina Salim Al Maqbali, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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