None listed
Conditions
Brief summary
Melatonin is a hormone produced naturally in the pineal gland at the base of the brain. It is important in regulating sleep. Usually melatonin levels in the body are high overnight and drop during the day to maintain the sleep-wake cycle. However, in critically ill patients there is evidence to suggest the normal secretion of melatonin is lost or diminished. This may contribute to sleep disruption in critically ill patients. This study will be conducted as a randomised double blind placebo controlled trial. Sixty patients with a tracheostomy in the intensive care unit (ICU) with poor sleep will be recruited. Participants will receive temazepam, a sleep medication, plus either placebo or melatonin at night for 7 nights. Hours of sleep during the day and the night will be documented through nursing observation and actigraphy (a wrist-watch which records wrist movements and translates it into sleep periods). Quality of sleep will be assessed with the use of the Richards Campbell Sleep Questionnaire. The study will help determine if there is a role for the addition of melatonin to usual sedative-hypnotic medication for the management of sleep disruption in ICU patients.
Interventions
Two melatonin 3mg capsules, 6mg dose, will be administered via naso-gastric tube at 21:30 for 7 consecutive nights, in addition to temazepam tablet. The starting dose of temazepam will be 10mg. Treating doctors may prescribe further sedative-hypnotic therapy, statum or single orders only, as rescue sleep therapy if patient does not sleep on assigned study medications. At the discretion of the treating team, the dose of temazepam may be increased the following night from 10mg, at daily increme
Two melatonin 3mg capsules, 6mg dose, will be administered via naso-gastric tube at 21:30 for 7 consecutive nights, in addition to temazepam tablet. The starting dose of temazepam will be 10mg. Treating doctors may prescribe further sedative-hypnotic therapy, statum or single orders only, as rescue sleep therapy if patient does not sleep on assigned study medications. At the discretion of the treating team, the dose of temazepam may be increased the following night from 10mg, at daily increments of 10mg, to a maximum of 30mg.
Sponsors
The Alfred
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years and older admitted to the ICU 2. Tracheostomy for weaning of ventilation 3. Glasgow Coma Scale (GCS) equal to or greater than 12 4. Difficulty sleeping as reported by patient or medical staff - 4 or less hours of nocturnal sleep and/or 4 or more awakenings overnight
Exclusion criteria
1. Patients on sedative infusions 2. Contraindications to enteral feeding and/or administration of medications 3. Pregnant or breast-feeding
Outcome results
None listed