Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
14/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Bonner

ORCID ID

Contact details

Cheriton House
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 854601

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes