Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
08/09/2008
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

Mr Richard Bourne

ORCID ID

Contact details

STH NHS Trust
Critical Care
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
+44 (0)114 271 3036
richard.bourne@sth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0059122216

Study information

Scientific title

Acronym

Study hypothesis

1. To evaluate the effect of melatonin therapy on the sleep characteristics of intensive care patients.
2. Secondary objectives include studying the incidence of delirium and bispectral index score between patients receiving melatonin or placebo.

Ethics approval

South Sheffield Research Ethics Committee (UK) on 09/01/03.

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Nervous System Diseases: Sleep disorders

Intervention

Melatonin versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

melatonin

Primary outcome measures

Sleep and delirium.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2003

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients admitted to the adult general intensive care unit with acute respiratory failure requiring mechanical ventilation and then a tracheostomy to assist weaning.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

48

Participant exclusion criteria

1. Expected length of stay of less than five further days
2. Previously treated for sleep disturbances
3. Not receiving target enteral feed volume or aspirates greater than 200mls
4. Previous history of convulsions
5. Psychiatric or neurological disease
6. Excessive alcohol consumption (equal to or greater than 50 units per week)
7. Recreational drug use
8. Sleep apnoea
9. Severe heart failure (NYHA III/ IV)
10. Sedative infusions must have been discontinued for more than 24 hours (propofol and alfentanil) or more than 36 hours (morphine and midazolam) with a Sedation Agitation Score (SAS) > 3

Recruitment start date

01/04/2003

Recruitment end date

30/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

STH NHS Trust
Sheffield
S10 2JF
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

Sheffield Teaching Hospitals - Central Campus (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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18423009

Publication citations

  1. Results

    Bourne RS, Mills GH, Minelli C, Melatonin therapy to improve nocturnal sleep in critically ill patients: encouraging results from a small randomised controlled trial., Crit Care, 2008, 12, 2, R52, doi: 10.1186/cc6871.

Additional files

Editorial Notes