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RECRUITING
NCT06509191
PHASE2/PHASE3

The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients

Sponsor: Sultan Qaboos University

View on ClinicalTrials.gov

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

DRUG

Intervention 1

Melatonin 5mg/day

DRUG

Intervention 2

Melatonin 8 mg/day

OTHER

Control

Placebo

Locations (2)

Sultan Qaboos University Hospital

Muscat, Oman

Sultan Qaboos University Hospital

Muscat, Oman