Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000839808
Ethics application status
Approved
Date submitted
20/01/2021
Date registered
30/06/2021
Date last updated
30/06/2021
Date data sharing statement initially provided
30/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Impact of Light and Odor on Alertness in Management of Sleep Inertia
Scientific title
The effect of bright light and odor on cognitive performance in management of sleep inertia
Secondary ID [1] 302021 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Inertia 318594 0
Condition category
Condition code
Neurological 316614 316614 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trained research assistants will deliver and monitor participant adherence to the protocol at all times during the 7 day in-laboratory visit which will be overseen by the chief investigators of the study. 24 participants will be randomised to one of 3 conditions: Odor, Bright light or Control (no intervention). Following an acclimatization sleep of 7 hours, participants will have sleep restricted to 5hr/day (4hr night sleep and a 1hr afternoon nap) for 4 experimental days (intervention days), followed by an 8hr recovery sleep period. Immediately upon wakening from each sleep, participants will be provided an intervention (odor: inhale proprietary odor: peppermint and cinnamon oil, light:seated in front of light box (approx 50 cm away at 1000lux), control:no intervention) for approximately 5 minutes (Total exposure across the experiment 8 times) followed by a 1hr cognitive behavioural test battery to examine the impact of sleep inertia (SI) on performance and the effectiveness of differing countermeasures. An additional cognitive performance test battery (approx 90min) will be conducted at approximately 4h intervals on each day. During sleep periods, polysomnography (involving attachment of electrodes to the scalp, face, chin and chest) will be used to measure sleep stages and heart rate.
Intervention code [1] 318315 0
Treatment: Other
Comparator / control treatment
Control group with no intervention
Control group
Active

Outcomes
Primary outcome [1] 324731 0
Cognitive performance as measured by the Psychomotor Vigilance Task
Timepoint [1] 324731 0
Immediately upon waking, followed by every 15 minutes in the first hour after waking from each period of sleep in the laboratory.
Primary outcome [2] 327300 0
Sleepiness as measured by the Karolinska Sleepiness Scale (KSS)
Timepoint [2] 327300 0
Immediately upon waking, followed by every 15 minutes in the first hour after waking from each period of sleep in the laboratory.
Secondary outcome [1] 385591 0
Sleep stages using polysomnography and electrocardiography (electrodes will be attached to participants' scalp, face, chin and chest)
Timepoint [1] 385591 0
Measured continuously during all 10 sleep periods in the laboratory
Secondary outcome [2] 385729 0
Melatonin (circadian marker) assessed using saliva samples
Timepoint [2] 385729 0
Approximately every two hours during wake during the experimental phase of the lab stay
Secondary outcome [3] 390810 0
Cognitive functioning, assessed using the psychomotor vigilance task (vigilant attention task)
Timepoint [3] 390810 0
Approximately every 4 hours during wake during the experimental phase of the lab stay
Secondary outcome [4] 394510 0
Heart rate using electrocardiography
Timepoint [4] 394510 0
Measured continuously during the laboratory stay
Secondary outcome [5] 394511 0

Cortisol (stress marker) levels measured by saliva samples
Timepoint [5] 394511 0
Approximately every two hours during wake during the experimental phase of the lab stay
Secondary outcome [6] 394512 0
Cognitive functioning assessed using Simulated driving
Timepoint [6] 394512 0
Approximately every 4 hours during wake during the experimental phase of the lab stay
Secondary outcome [7] 394513 0
Cognitive functioning assessed using NASA cohesion task
Timepoint [7] 394513 0
Approximately every 4 hours during wake during the experimental phase of the lab stay
Secondary outcome [8] 394514 0
Cognitive functioning, assessed using the Automated Neuropsychological Assessment Metrics
Timepoint [8] 394514 0
Approximately every 4 hours during wake during the experimental phase of the lab stay

Eligibility
Key inclusion criteria
Healthy, young adults (18-40 years) with normal sleep/wake behaviour.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Self reported habitual nightly sleep amounts < 6 or > 9 hours; self reported night time lights out earlier than 2100 hours during weeknights; self reported morning wake-up times
later than 0900 during weekdays; self reported habitual napping > 1 time a week; self reported caffeine use > 400 mg (e.g. 8 caffeinated sodas or approximately 3 to 4 cups of coffee) per day, history of cardiovascular disease (including but not limited to arrhythmias, valvular heart disease, congestive heart failure, or myocardial infarction); history of neurologic disorder (including but not limited to epilepsy or another seizure disorder,
amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorder); underlying pulmonary disease requiring daily inhaler use; kidney disease or abnormalities, liver disease or abnormalities; self reported history of psychiatric disorder requiring hospitalization or psychiatric product for any length of time; self reported or suspected regular nicotine use (> 1 cigarette or equivalent per week) within the last year; self reported or suspected heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week or as determined by the examining study licensed physician); self reported or suspected current use of other illicit drugs (including but not limited to benzodiazepines, amphetamines, cocaine, marijuana); resting blood pressure above 140/90 or resting pulse > 110; BMI > 30 (Obese Class I or greater); clinically significant values (as determined by the reviewing study physician) for any haematology or chemistry parameter; positive urine drug result during screening visit; currently taking corticosteroid or anti-inflammatory medications.

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)
Central randomisation by computer using the online research randomizer tool (https://www.randomizer.org/)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomizer tool online at run level
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To adequately account for inter-individual differences statistically, a mixed effects analysis of variance (ANOVA) will be used with a random effect of subject and fixed effects of time (repeated post wake-up performance trials) and countermeasure condition (odor, light or control). Planned contrasts will be used to make specific comparisons with the active control condition. Primary outcome variables include indicators of performance from the cognitive test battery.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306442 0
University
Name [1] 306442 0
Naval Postgraduate School
Country [1] 306442 0
United States of America
Primary sponsor type
University
Name
Naval Postgraduate School
Address
1 University Circle, Monterey, CA 93943, United States
Country
United States of America
Secondary sponsor category [1] 306959 0
None
Name [1] 306959 0
Address [1] 306959 0
Country [1] 306959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306650 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 306650 0
Ethics committee country [1] 306650 0
Australia
Date submitted for ethics approval [1] 306650 0
Approval date [1] 306650 0
23/09/2019
Ethics approval number [1] 306650 0

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

Contacts
Principal investigator
Name 104554 0
Prof Siobhan Banks
Address 104554 0
University of South Australia, Magill Campus, St Bernards Rd, Magill, SA, 5072
Country 104554 0
Australia
Phone 104554 0
+61 08 8302 1712
Fax 104554 0
Email 104554 0
[email protected]
Contact person for public queries
Name 104555 0
Siobhan Banks
Address 104555 0
University of South Australia, Magill Campus, St Bernards Rd, Magill, SA, 5072
Country 104555 0
Australia
Phone 104555 0
+61 08 8302 1712
Fax 104555 0
Email 104555 0
[email protected]
Contact person for scientific queries
Name 104556 0
Siobhan Banks
Address 104556 0
University of South Australia, Magill Campus, St Bernards Rd, Magill, SA, 5072
Country 104556 0
Australia
Phone 104556 0
+61 08 8302 1712
Fax 104556 0
Email 104556 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Approval has not been granted to share individual participant data.


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.