Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000719235
Ethics application status
Not yet submitted
Date submitted
19/08/2009
Date registered
21/08/2009
Date last updated
21/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of interventional light exposure on sleep-wake cycles in a post-operative cardiac population.
Scientific title
The effects of interventional light exposure on sleep-wake cycles in a post-operative cardiac population.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative sleep patterns 243552 0
Post-operative pain 243553 0
Post-operative mood 243554 0
Condition category
Condition code
Surgery 239855 239855 0 0
Other surgery
Cardiovascular 239856 239856 0 0
Other cardiovascular diseases
Other 239862 239862 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the interventional group will be given light boxes emitting light of up to 10 000 lux to use for a set period of individually determined time of the morning throughout their hospital stay, both in the intensive care unit (ICU) and ward. This should increase their daily light exposure. During the night patients will be given eye masks to reduce night time light exposure.
Intervention code [1] 241158 0
Treatment: Devices
Comparator / control treatment
The control groups will have standard hospital treament while being given similar light boxes that are modified to give out less than 10 lux while having a negligible effect on light exposure.
Control group
Placebo

Outcomes
Primary outcome [1] 240631 0
core body temperature rhythm changes (as measured by ingestible temperature probes) - reduction in rhythm, phase shift, changes in amplitude
Timepoint [1] 240631 0
at baseline (pre-operative, 1 week), post-operatively in hospital (1 week), post-operatively at home (1 week), at 12 weeks (1week)
Primary outcome [2] 240632 0
changes in melatonin as measured by saliva and urine levels - reduction in rhythm, phase shift, changes in amplitude
Timepoint [2] 240632 0
at baseline (pre-operative, 1 week), post-operatively in hospital (1 week), post-operatively at home (1 week), at 12 weeks (1week)
Primary outcome [3] 240633 0
mean beck depression score
Timepoint [3] 240633 0
at baseline (pre-operative), post-operatively in hospital (1 week post-operatively), post-operatively at home (2 week post-operatively), at 13 weeks
Primary outcome [4] 240634 0
sleep-wake cycle patterns as measured by actigraphy
Timepoint [4] 240634 0
at baseline (pre-operative, 1 week), post-operatively in hospital (1 week), post-operatively at home (1 week), at 12 weeks (1week)
Secondary outcome [1] 257265 0
Pain management in the hospital environment as measured by visual analogue scales
Timepoint [1] 257265 0
at baseline (pre-operative, 1 week wherever necessary), post-operatively in hospital (1 week, every 6 hours), post-operatively at home (1 week, every six hours), at 12 weeks (1week wherever necessary)

Eligibility
Key inclusion criteria
Be scheduled for elective cardiac bypass surgery at Auckland City Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Scheduled for a re-do of a surgical procedure.
Scheduled for requiring magnetic resonance imaging (MRI) as the core body temperature emasuring equipment is incompatible.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1959 0
New Zealand
State/province [1] 1959 0

Funding & Sponsors
Funding source category [1] 237525 0
University
Name [1] 237525 0
University of Auckland
Country [1] 237525 0
New Zealand
Primary sponsor type
Individual
Name
Anisoara Jardim
Address
Department of Anaesthesiology
98 -100 Mountain Road
Epsom, Auckland.
Country
New Zealand
Secondary sponsor category [1] 237000 0
Individual
Name [1] 237000 0
Dr. Guy Warman
Address [1] 237000 0
Department of Anaesthesiology
98 -100 Mountain Road
Epsom, Auckland.
Country [1] 237000 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243658 0
Ethics committee address [1] 243658 0
Ethics committee country [1] 243658 0
Date submitted for ethics approval [1] 243658 0
19/08/2009
Approval date [1] 243658 0
Ethics approval number [1] 243658 0

Summary
Brief summary
Sleep is important for patient post-operative recovery. Following cardiac surgery, patients are often found to have disturbed sleep. If sleep quality or quantity is compromised there may be a consequent delay in post-operative recovery. The hospital environment has various characteristics which may cause sleep disruption: the lighting environment is thought to be weaker than a natural lighting environment, patients are in pain, they are regularly awoken for monitoring and the hospital is noisy . As a response to the lighting environment, the circadian clock controls the timing of various physiological processes, including sleep. Consequently, sleep-wake cycles are influenced by lighting and time of day. We will monitor activity-rest rhythms to determine whether the disrupted sleep commonly experienced by the post-operative patient is possibly due to circadian disruption, inadequate pain management or some other variable. We aim to establish whether the use of an interventional therapeutic light source can improve post-operative recovery. Hypothetically, if circadian disruption is the underlying cause of sleep disruption, correctly timed light exposure should consolidate sleep-wake cycle timing, improving sleep quantity and quality. This may also have positive secondary outcomes such as improved mood and decreased recovery time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30074 0
Address 30074 0
Country 30074 0
Phone 30074 0
Fax 30074 0
Email 30074 0
Contact person for public queries
Name 13321 0
Anisoara Jardim
Address 13321 0
Department of Anaesthesiology
98 -100 Mountain Road
Epsom, Auckland.
Country 13321 0
New Zealand
Phone 13321 0
+64 21 705 562
Fax 13321 0
Email 13321 0
[email protected]
Contact person for scientific queries
Name 4249 0
Anisoara Jardim
Address 4249 0
Department of Anaesthesiology
98 -100 Mountain Road
Epsom, Auckland.
Country 4249 0
New Zealand
Phone 4249 0
+64 21 705 562
Fax 4249 0
Email 4249 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.