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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intervention 1
DrugMelatonin 5mg/day
Intervention 2
DrugMelatonin 8 mg/day
Control
Other interventionPlacebo
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Melatonin 5mg/dayExperimental treatment 1 intervention
Group B: Melatonin 8 mg/dayExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of delirium
Incidence of delirium development during hospitalisation using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM).
Time frame
5 daysSecondary outcomes
1
Onset time of delirium
The time from hospital admission to the first diagnosis of delirium is measured in hours or days from admission and is assessed daily during the first 5 days of hospitalization. The development of deleiriun will be ascertain assessed daily by trained research assessors, using the 3D-CAM tool.
Time frame
5 days2
Duration of delirium during hospitalization
The total time a patient remains in a state of delirium during the hospital stay is recorded in hours or days using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM). This duration is assessed daily during the first 5 days of hospitalization.
Time frame
5 days3
Sleep pattern and night awakenings
The quality of sleep, including the number of awakenings and disruptions during the night, is assessed using patient self-reports, nursing records, or information from attendants. Night awakenings are quantified by the number of instances per night and are evaluated nightly during the first 5 days of hospitalization by trained research assitant .
Time frame
5 days4
Days utilizing physical restraints.
The number of days physical restraints were used during hospitalization is recorded in days based on hospital records and staff documentation, and is assessed for first 5 days .
Time frame
5 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov