Melatonin in Intensive Therapy Unit (ITU) patients

ISRCTN	ISRCTN23173759
DOI	https://doi.org/10.1186/ISRCTN23173759
Protocol serial number	N0227109607
Sponsor	Department of Health (UK)
Funder	South Tees Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Stephen Bonner
Scientific

Cheriton House
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone	+44 (0)1642 854601

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Can melatonin normalise the sleep pattern in patients who have been on ITU for prolonged periods of time?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nervous System Diseases: Sleep disorders
Intervention	Randomised controlled trial in which melatonin will be given to patients who have ceased to be sedated for their clinical care on ITU, and their physiological and psychological recovery will be recorded. Standard scoring systems are appropriate for this study.
Intervention type	Other
Primary outcome measure(s)	Time to return to a normal hypnogram and perceived normal pattern of sleep.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/08/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	ITU patients who have required prolonged sedation (over 24 h) and who will require further ITU management for some days.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2002
Date of final enrolment	31/08/2003

Cheriton House

Middlesbrough
TS4 3BW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan