RecruitingPhase 3Phase 4ACTRN12610000008022

Exogenous Melatonin to Improve Sleep in Critically Ill Patients

The effect of exogenous melatonin versus placebo on sleep improvement in tracheostomised Intensive Care Unit (ICU) patients.


Sponsor

The Alfred

Enrollment

60 participants

Start Date

Jun 22, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether giving melatonin — a natural sleep hormone — at night can help critically ill patients in the intensive care unit (ICU) sleep better. Patients in the ICU often have disrupted sleep, which can slow recovery. This trial will give patients who have a tracheostomy (breathing tube in the throat) either melatonin or a placebo (dummy pill) along with their usual sleep medication for one week. You may be eligible if: - You are 18 years of age or older - You are admitted to the ICU - You have a tracheostomy to help wean you off a ventilator (breathing machine) - Your Glasgow Coma Scale score is 12 or higher (meaning you are alert enough to communicate) - You are having trouble sleeping (fewer than 4 hours of night-time sleep or 4 or more wake-ups per night) You may NOT be eligible if: - You are on a continuous sedative drip - You have a reason you cannot take medicines by mouth or feeding tube - You are pregnant or breastfeeding Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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. Trea

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.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12610000008022