Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000142336
Ethics application status
Approved
Date submitted
5/03/2007
Date registered
19/03/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute alerting effects of daytime exposure to specific wavelengths of light
Scientific title
The effectiveness of exposure to different colours of light in improving alertness and psychomotor vigilance in sleep restricted and non-sleep restricted healthy adult participants
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary health condition: Alertness and psychomotor vigilance in healthy human volunteers. 2132 0
Condition category
Condition code
Mental Health 2228 2228 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Ocular exposure to specific monochromatic wavelengths of light administered using a specialised light delivery system.
For three hours, each participant will be exposed to one of the following wavelengths of light: violet light (420nm), blue light (460nm), green light (555nm), or red light (620nm).
Intervention code [1] 1632 0
Behaviour
Intervention code [2] 2651 0
Treatment: Devices
Comparator / control treatment
No treatment (i.e. no exposure to light other than background room lighting)
Control group
Placebo

Outcomes
Primary outcome [1] 3942 0
Psychomotor Vigilance Task mean reaction time (msec).
Timepoint [1] 3942 0
During and immediately after light exposure, expressed relative to baseline (i.e. immediately before light exposure).
Secondary outcome [1] 6623 0
Subjective sleepiness rating on the Karolinska Sleepiness Scale.
Timepoint [1] 6623 0
During and immediately after light exposure, expressed relative to baseline (i.e. immediately before light exposure).

Eligibility
Key inclusion criteria
(1) Male and female adults aged 18 to 30 years inclusive
(2) Healthy
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Individuals who have engaged in shiftwork/nightwork in the past 3 years and/or transmeridian travel in the past 3 months.
(2) Individuals who smoke, report high caffeine intake and/or high alcohol consumption.
(3) Individuals who screen positive for drugs of abuse following comprehensive urine toxicological analysis.
(4) Women who are pregnant, lactating or planning to become pregnant during the study period.
(5) A history of alcohol/drug dependence.
(6) Current, recent (<3 months) or chronic history of use of drugs or medication that affect the central nervous system (except non-steroid topical creams, oral contraceptives and occasional use of mild pain killers.
(7) History of psychiatric illness.
(8) Recent acute or chronic medical illness.
(9) Abnormal sleep patterns/sleep disorders.
(10) Auditory defects.
(11) Any form of photophobia including drug-induced, epilepsy, seizures, vertigo or migraine.
(12) Individuals with diseases of the visual system.
(13) Females who are not taking a medically approved form of birth control.

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)
Allocation involves contacting the holder of the allocation schedule who is off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 605 0
3800

Funding & Sponsors
Funding source category [1] 3176 0
Government body
Name [1] 3176 0
National Health and Medical Research Council
Country [1] 3176 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton Victoria 3800
Country
Australia
Secondary sponsor category [1] 2162 0
None
Name [1] 2162 0
N/A
Address [1] 2162 0
Country [1] 2162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5155 0
Alfred Hospital Human Ethics Committee
Ethics committee address [1] 5155 0
Ethics committee country [1] 5155 0
Australia
Date submitted for ethics approval [1] 5155 0
Approval date [1] 5155 0
05/07/2007
Ethics approval number [1] 5155 0
109/07
Ethics committee name [2] 5158 0
Monash University Standing Committee on Ethics in Research involving Humans (SCERH)
Ethics committee address [2] 5158 0
Ethics committee country [2] 5158 0
Australia
Date submitted for ethics approval [2] 5158 0
Approval date [2] 5158 0
30/01/2007
Ethics approval number [2] 5158 0
2006/1010

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

Contacts
Principal investigator
Name 27566 0
Address 27566 0
Country 27566 0
Phone 27566 0
Fax 27566 0
Email 27566 0
Contact person for public queries
Name 10821 0
Dr. Shantha.Rajaratnam
Address 10821 0
Monash University
School of Psychology, Psychiatry and Psychological Medicine
Building 17 (PO Box 17)
Clayton Victoria 3800
Country 10821 0
Australia
Phone 10821 0
+61 3 99053934
Fax 10821 0
Email 10821 0
[email protected]
Contact person for scientific queries
Name 1749 0
Dr. Shantha.Rajaratnam
Address 1749 0
Monash University
School of Psychology, Psychiatry and Psychological Medicine
Building 17 (PO Box 17)
Clayton Victoria 3800
Country 1749 0
Australia
Phone 1749 0
+61 3 99053934
Fax 1749 0
Email 1749 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.