The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients

ConditionDelirium
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorSultan Qaboos University

About this trial

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.

Eligibility criteria

Qualifiers

Patient aged 65 years and above acutely admitted under the care of General Internal Medicine Unit

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intervention 1
  • Intervention 2
  • Control

Treatment groups

240 Participants
are divided into 3 treatment groups

Sponsors and collaborators