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Trial registered on ANZCTR


Registration number
ACTRN12610000008022
Ethics application status
Approved
Date submitted
18/12/2009
Date registered
6/01/2010
Date last updated
9/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Exogenous Melatonin to Improve Sleep in Critically Ill Patients
Scientific title
The effect of exogenous melatonin versus placebo on sleep improvement in tracheostomised Intensive Care Unit (ICU) patients.
Secondary ID [1] 1226 0
Nil
Universal Trial Number (UTN)
U1111-1112-9529
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor sleep in tracheostomised ICU patients. 256464 0
Condition category
Condition code
Other 256602 256602 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 255727 0
Treatment: Drugs
Comparator / control treatment
Two matching placebo capsules containing sodium bicabonate (536mg) 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.
Control group
Placebo

Outcomes
Primary outcome [1] 257492 0
Nocturnal total sleep time (22:00 to 06:00) - excludes time spent asleep after sleep rescue therapy is administered.

Two objective measures of sleep duration will be used to estimate consistency of results. These measures include wrist actigraphy, and nursing assessment. Quality of sleep will be determined by the Richards-Campbell Sleep Questionnaire (RCSQ).
Timepoint [1] 257492 0
22:00 to 06:00 during 7 nights of treatment regimen.
Secondary outcome [1] 262687 0
Diurnal total sleep time (06:00 to 22:00).

Two objective measures of sleep duration will be used to estimate consistency of results. These measures include wrist actigraphy, and nursing assessment.
Timepoint [1] 262687 0
During 7 days of treatment regimen
Secondary outcome [2] 262749 0
Number of awakenings during nocturnal sleep.

Two objective measures of nocturnal awakenings will be used to estimate consistency of results. These measures include wrist actigraphy, and nursing assessment.
Timepoint [2] 262749 0
During 7 days of treatment regimen.
Secondary outcome [3] 262750 0
Episodes of agitation.

The Motor Activity Assessment Scale (MAAS) is routinely used in The Alfred ICU for assessment of sedation and agitation. The MAAS is located on the back of the ICU observation chart and patient's MAAS scores are documented hourly on the front of the observation chart by nursing staff. A MAAS score of 5 or more indicates agitation.
Timepoint [3] 262750 0
During 7 days of treatment regimen.
Secondary outcome [4] 262751 0
Length of stay in ICU.

This is documented in ICUActive.
Timepoint [4] 262751 0
From ICU admission to date of discharge from ICU

Eligibility
Key inclusion criteria
1. Patients 18 years and older admitted to the ICU
2. Tracheostomy for weaning of ventilation
3. Glasgow Coma Scale (GCS) equal to or greater than 12
4. Difficulty sleeping as reported by patient or medical staff - 4 or less hours of nocturnal sleep and/or 4 or more awakenings overnight
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients on sedative infusions
2. Contraindications to enteral feeding and/or administration of medications
3. Pregnant or breast-feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinical pharmacists, nursing and medical staff may identify and refer to the principal investigator patients who are potentially eligible for this study. If patients meet the criterias for inclusion into this study, a member of the research team will consent the patient or the person responsible for the patient. Treating doctors will indicate whether individual patients are suitable to provide written informed consent. Patient enrolment will only occur from Monday to Friday as there is insufficient staff on the weekend to assist with identification of eligible patients.

On study Day 1, The Alfred Clinical Trial Pharmacy will randomise the consented patients by computerised block randomisation, in a ratio 1:1, to melatonin 6mg plus temazepam 10mg or placebo plus temazepam 10mg. Melatonin and placebo capsules will be dispensed by The Alfred Clinical Trial pharmacists. This ensures that investigators, participants and medical staff are blinded to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised block randomisation, in a ratio 1:1
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256200 0
Hospital
Name [1] 256200 0
Pharmacy Department
Country [1] 256200 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Commercial Rd
Melbourne
Victoria
3004
Country
Australia
Secondary sponsor category [1] 251542 0
None
Name [1] 251542 0
Address [1] 251542 0
Country [1] 251542 0
Other collaborator category [1] 1010 0
Individual
Name [1] 1010 0
Ms Bianca Levkovich
Address [1] 1010 0
The Alfred
Commercial Rd
Melbourne
Victoria
3004
Country [1] 1010 0
Australia
Other collaborator category [2] 1011 0
Individual
Name [2] 1011 0
Ms Susan Poole
Address [2] 1011 0
The Alfred
Commercial Rd
Melbourne
Victoria
3004
Country [2] 1011 0
Australia
Other collaborator category [3] 1012 0
Individual
Name [3] 1012 0
Dr Tim Leong
Address [3] 1012 0
The Alfred
Commercial Rd
Melbourne
Victoria
3004
Country [3] 1012 0
Australia
Other collaborator category [4] 1013 0
Individual
Name [4] 1013 0
Dr Andrew Hilton
Address [4] 1013 0
The Alfred
Commercial Rd
Melbourne
Victoria
3004
Country [4] 1013 0
Australia
Other collaborator category [5] 1014 0
Individual
Name [5] 1014 0
A/Prof Warwick Butt
Address [5] 1014 0
The Alfred
Commercial Rd
Melbourne
Victoria
3004
Country [5] 1014 0
Australia
Other collaborator category [6] 1015 0
Individual
Name [6] 1015 0
Professor Matthew Naughton
Address [6] 1015 0
The Alfred
Commercial Rd
Melbourne
Victoria
3004
Country [6] 1015 0
Australia
Other collaborator category [7] 1016 0
Individual
Name [7] 1016 0
Professor Michael Dooley
Address [7] 1016 0
The Alfred
Commercial Rd
Melbourne
Victoria
3004
Country [7] 1016 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258302 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 258302 0
The Alfred
Commercial Rd
Melbourne
Victoria
3004
Ethics committee country [1] 258302 0
Australia
Date submitted for ethics approval [1] 258302 0
16/11/2009
Approval date [1] 258302 0
Ethics approval number [1] 258302 0
AH: 424/09

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30636 0
Address 30636 0
Country 30636 0
Phone 30636 0
Fax 30636 0
Email 30636 0
Contact person for public queries
Name 13883 0
Miss Thuy Bui
Address 13883 0
The Alfred
Commerical Rd
Melbourne
Victoria
3004
Country 13883 0
Australia
Phone 13883 0
+61 3 9076 2061
Fax 13883 0
Email 13883 0
[email protected]
Contact person for scientific queries
Name 4811 0
Miss Thuy Bui
Address 4811 0
The Alfred
Commerical Rd
Melbourne
Victoria
3004
Country 4811 0
Australia
Phone 4811 0
+61 3 9076 2061
Fax 4811 0
Email 4811 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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