Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0227109607
Study information
Scientific title
Acronym
Study hypothesis
Can melatonin normalise the sleep pattern in patients who have been on ITU for prolonged periods of time?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Time to return to a normal hypnogram and perceived normal pattern of sleep.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2002
Overall trial end date
31/08/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
ITU patients who have required prolonged sedation (over 24 h) and who will require further ITU management for some days.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2002
Recruitment end date
31/08/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cheriton House
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Tees Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list