Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000180213
Ethics application status
Approved
Date submitted
25/11/2008
Date registered
17/04/2009
Date last updated
9/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study to monitor light exposure and sleep wake cycles in post-operative cardiac patients and its implications for hospital stay and depression.
Scientific title
A pilot study to monitor light exposure and sleep wake cycles in post-operative cardiac patients and its implications for hospital stay and depression.
Secondary ID [1] 262347 0
No Secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Light exposure in the hospital environment 4017 0
Condition category
Condition code
Other 4222 4222 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients have their light exposure and activity levels monitored using actigraphy and daysimetry. Patients are asked to wear both items from the evening following cardiac surgery until their discharge from hospital. Actiwatches and daysimeters both measure light levels as well as measuring rest-activity rhythms. One sits on the wrist and one on the ear. The concept is that they will hav differing results for the same patient due to their positioning.
Intervention code [1] 3741 0
Not applicable
Comparator / control treatment
No control - validation study of the two different types of equipment. The study compares the well validated and more commonly used actigraphy (actiwatch on the wrist) with a newer device which is thought to be more useful due to its ideal positioning close to the retina.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5113 0
Light exposure in hospital environment measured using two methods of measurement, actigraphy is a validated method of light and activity measurement. Daysimetry results will then be correlated with the actigraphy results.
Timepoint [1] 5113 0
Light exposure and activity levels measured throughout their hospital stay, starting immediately post-surgery
Secondary outcome [1] 8609 0
Mood disruption measured using a questionnaire
Timepoint [1] 8609 0
Mood is measured using a questionnaire administered pre-surgery and on the last day of hospitalisation. Questionnaires used: Hamilton Depression Scale, Beck Depression Questionnaire, Hospital Anxiety and Depression Scale, Profile of Mood States.

Eligibility
Key inclusion criteria
Patients must be scheduled for cardiac surgery
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any condition which may put the patient at risk by participating or any condition which may cause confounding of results

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1403 0
New Zealand
State/province [1] 1403 0

Funding & Sponsors
Funding source category [1] 4203 0
Self funded/Unfunded
Name [1] 4203 0
University of Auckland
Country [1] 4203 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
7 Symonds St
Auckland Central
1010
Country
New Zealand
Secondary sponsor category [1] 3776 0
None
Name [1] 3776 0
Address [1] 3776 0
Country [1] 3776 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Hospitals are characterized by their lack of strong daily light-dark cycles. Light levels in the intensive care unit and ward are generally much lower than normal during the day and higher than normal at night. Appropriately timed administration of bright light has been shown to be highly effective in entraining the circadian clock, improving sleep timing and mood of depressed patients in other clinical settings. In this study we aim to investigate the validity of a novel head worn device for the measurement of light exposure and sleep/ wake cycles in post-operative cardiac patients. Subjects will be asked to wear a wrist worn actimeter with an integrated light sensor and a head worn daysimeter (incorporating light and activity sensors). Data from this pilot study will for the first time provide accurate assessments of eye level light exposures in post-operative patients. Simultaneous monitoring of mood will also enable the determination of the influence of light exposure on post-operative depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29160 0
Address 29160 0
Country 29160 0
Phone 29160 0
Fax 29160 0
Email 29160 0
Contact person for public queries
Name 12317 0
Anisoara Jardim
Address 12317 0
98 Mountain Rd
Epsom
Auckland
1024
Country 12317 0
New Zealand
Phone 12317 0
+64 21 705562
Fax 12317 0
Email 12317 0
[email protected]
Contact person for scientific queries
Name 3245 0
Anisoara Jardim
Address 3245 0
98 Mountain Rd
Epsom
Auckland
1024
Country 3245 0
New Zealand
Phone 3245 0
+64 21 705562
Fax 3245 0
Email 3245 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.