Using melatonin to prevent delirium in hospitalized older patients
Effect of Melatonin Versus Placebo for Prevention of Delirium Among Medically Hospitalized Patients: Study Protocol for a Single-Center, Double-Blinded, Randomised Controlled Trial
This study is testing if melatonin can help prevent delirium in older patients aged 65 and up who are in the hospital.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Sultan Qaboos University Academic / other |
| Locations | 2 sites (Muscat and 1 other locations) |
| Trial ID | NCT06509191 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of melatonin, a neurohormone that regulates the sleep-wake cycle, in preventing delirium among medically hospitalized patients aged 65 and older. It employs a randomized, double-blind, placebo-controlled design to ensure robust results. Given the high prevalence of delirium in this demographic and its association with adverse health outcomes, the study aims to provide valuable insights into effective prevention strategies. The trial addresses limitations of previous studies by utilizing a larger sample size and a more rigorous methodology.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 65 years and older who are acutely admitted to the General Internal Medicine Unit.
Not a fit: Patients who are already experiencing delirium at the time of randomization or those with specific contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of delirium in hospitalized older adults, improving their overall health outcomes.
How similar studies have performed: While previous trials have explored melatonin's role in delirium prevention, this study aims to address their limitations, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit Exclusion Criteria: * Patients admitted to the ward, however meeting requirement for vasopressors or non-invasive ventilation. * Patient admitted through emergency to Intensive Care Unit (ICU) or High Dependency Unit (HDU). * Aphasic patients. * Patients with language barriers. * Already taking melatonin or ramelteon at the time of randomization. * Presence of delirium at the time of randomization. * If enteral medications are contraindicated due to gastrointestinal conditions. * If enteral medications are not allowed due to unavailability of nasogastric tube * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (liver function tests) \> 3 times the upper limit of normal. * Patient on strong cytochrome P450 1A2 (CYP1A2) inhibitors (namely: fluvoxamine and viloxazine) . * Patient with active alcohol drinking or admitted with alcohol withdrawal syndrome. * Subject or proxy unable to provide informed consent within 24 hours of admission. * Patients with the following autoimmune diseases (Rheumatoid arthritis, inflammatory bowel disease and systemic lupus erythematosus). * Allergy to melatonin.
Where this trial is running
Muscat and 1 other locations
- Sultan Qaboos University Hospital — Muscat, Oman (Not_yet_recruiting)
- Sultan Qaboos University Hospital — Muscat, Oman (Recruiting)
Study contacts
- Study coordinator: Abdullah M Al Alawi, FRACP
- Email: dr.abdullahalalawi@gmail.com
- Phone: +96895384990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.