Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001503718p
Ethics application status
Submitted, not yet approved
Date submitted
21/11/2022
Date registered
2/12/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
2/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of caffeine in restoring cognitive declines across 24 hours of sustained wakefulness
Scientific title
The efficacy of caffeine in restoring cognitive declines across 24 hours of sustained wakefulness in healthy adults
Secondary ID [1] 308456 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 328259 0
Sleep 328260 0
Condition category
Condition code
Public Health 325302 325302 0 0
Other public health
Neurological 325362 325362 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will run for a duration of five weeks and includes a one-week baseline monitoring period and a four-week intervention period. This study will incorporate a randomised, double-blind, placebo-controlled crossover experimental design to assess the effect of three different caffeine doses (100 mg, 200 mg and 400 mg). The intervention is the administration of caffeine to be taken orally in capsule form. Each participant will be exposed to four conditions (including the control) using a Latin square design. Each condition will be separated by a six-day washout period. Interventions include:
- 100 mg caffeine administered as 2 x 50 mg doses at 15 and 19 h post wake
- 200 mg caffeine administered as 2 x 100 mg doses at 15 and 19 h post wake
- 400 mg caffeine administered as 2 x 200 mg doses at 15 and 19 h post wake
The intervention will be administered by a member of the research team during each trial and participants will be monitored during the consumption of the capsule. Additionally, saliva samples will be taken in 2 h intervals across each trial to assess salivary caffeine concentrations.

Participants will arrive for each overnight trial 9 h after their morning waking with the trial will conclude after 24 h of sustained wakefulness. As such, each overnight trial will run for 15.5 h. Upon conclusion of the trial, participants will be transported home to undertake a subsequent recovery sleep bout. This recovery sleep bout will be recorded using in-home sleep monitoring that includes the Somfit device. Participants will apply the Somfit device to their forehead via an adhesive electrode patch. Subjective sleep measures will be recorded via an electronic sleep diary that participants will complete on their phone via an email link.
Intervention code [1] 324900 0
Lifestyle
Intervention code [2] 324901 0
Treatment: Other
Comparator / control treatment
Glucose will be administered as the placebo control in identical appearing capsule form at 15 and 19 h post wake.
Control group
Placebo

Outcomes
Primary outcome [1] 333168 0
Psychomotor Vigilance Task: Response time (ms)
Timepoint [1] 333168 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Primary outcome [2] 333220 0
Psychomotor Vigilance Task: Number of lapses (latency >500ms)
Timepoint [2] 333220 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Primary outcome [3] 333221 0
Psychomotor Vigilance Task: Number of errors (count)
Timepoint [3] 333221 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [1] 416202 0
Stroop Task: Proportion of correct responses for all trials (%)
PRIMARY OUTCOME
Timepoint [1] 416202 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [2] 416203 0
Stroop Task: Proportion of correct responses for congruent trials (colour/word match) (%)
PRIMARY OUTCOME
Timepoint [2] 416203 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [3] 416204 0
Stroop Task: Proportion of correct responses for incongruent trials (colour/word mismatch) (%)
PRIMARY OUTCOME
Timepoint [3] 416204 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [4] 416205 0
Stroop Task: Response time of correct responses for all trials (ms)
PRIMARY OUTCOME
Timepoint [4] 416205 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [5] 416206 0
Stroop Task: Response time of correct responses for congruent trials (colour/word match) (ms)
PRIMARY OUTCOME
Timepoint [5] 416206 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [6] 416207 0
Stroop Task: Response time of correct responses for incongruent trials (colour/word mismatch) (ms)
PRIMARY OUTCOME
Timepoint [6] 416207 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [7] 416208 0
Postural sway assessment: 95% confidence ellipse enclosing the centre of pressure (cm2) with data collected using force plates.
PRIMARY OUTCOME
Timepoint [7] 416208 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [8] 416209 0
Postural sway assessment: Length of the centre of pressure path (cm) with data collected using force plates.
PRIMARY OUTCOME
Timepoint [8] 416209 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [9] 416210 0
Karolinska Sleepiness Scale: 1-9 Likert scale (1 extremely alert to 9 extremely sleepy)
PRIMARY OUTCOME
Timepoint [9] 416210 0
Measured at 10, 12, 14, 16 (1 h post first dose), 18 (3 h post first dose), 20 (5 h post first dose/1 h post second dose), 22 (7 h post first dose/3 h post second dose), and 24 h (9 h post first dose/5 h post second dose) post wake.
Secondary outcome [10] 416211 0
Sleep monitoring: Objective total sleep time (min) with data collected using the Somfit device and the outcome determined by accessing Somfit analytics.
Timepoint [10] 416211 0
Duration of next-day recovery sleep bout
Secondary outcome [11] 416212 0
Sleep monitoring: Objective sleep efficiency (%) with data collected using the Somfit device and the outcome determined by accessing Somfit analytics.
Timepoint [11] 416212 0
Duration of next-day recovery sleep bout
Secondary outcome [12] 416213 0
Sleep monitoring: Objective sleep onset latency (min) with data collected using the Somfit device and the outcome determined by accessing Somfit analytics.
Timepoint [12] 416213 0
Duration of next-day recovery sleep bout
Secondary outcome [13] 416214 0
Sleep monitoring: Objective wake after sleep onset (min) with data collected using the Somfit device and the outcome determined by accessing Somfit analytics.
Timepoint [13] 416214 0
Duration of next-day recovery sleep bout
Secondary outcome [14] 416215 0
Sleep monitoring: Objective N1 sleep (min and %) with data collected using the Somfit device and the outcome determined by accessing Somfit analytics.
Timepoint [14] 416215 0
Duration of next-day recovery sleep bout
Secondary outcome [15] 416216 0
Sleep monitoring: Objective N2 sleep (min and %) with data collected using the Somfit device and the outcome determined by accessing Somfit analytics.
Timepoint [15] 416216 0
Duration of next-day recovery sleep bout
Secondary outcome [16] 416217 0
Sleep monitoring: Objective N3 sleep (min and %) with data collected using the Somfit device and the outcome determined by accessing Somfit analytics.
Timepoint [16] 416217 0
Duration of next-day recovery sleep bout
Secondary outcome [17] 416218 0
Sleep monitoring: Objective REM sleep (min and %) with data collected using the Somfit device and the outcome determined by accessing Somfit analytics.
Timepoint [17] 416218 0
Duration of next-day recovery sleep bout
Secondary outcome [18] 416219 0
Sleep diary: Subjective total sleep time (min)
Timepoint [18] 416219 0
Duration of next-day recovery sleep bout
Secondary outcome [19] 416220 0
Sleep diary: Subjective sleep efficiency (%)
Timepoint [19] 416220 0
Duration of next-day recovery sleep bout
Secondary outcome [20] 416221 0
Sleep diary: Subjective sleep onset latency (min)
Timepoint [20] 416221 0
Duration of next-day recovery sleep bout
Secondary outcome [21] 416222 0
Sleep diary: Subjective wake after sleep onset (min)
Timepoint [21] 416222 0
Duration of next-day recovery sleep bout
Secondary outcome [22] 416223 0
Sleep diary: Subjective sleep quality (1-5 Likert)
Timepoint [22] 416223 0
Duration of next-day recovery sleep bout

Eligibility
Key inclusion criteria
Healthy male and females aged between 18 and 40 years
No reported medical or sleep condition
Daily habitual caffeine consumption <300 mg
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The use of cigarettes, drugs, or medications known to affect sleep in the three months prior to study admission.
Undertaken shift work or transmeridian travel in the month prior to study admission.

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?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312699 0
University
Name [1] 312699 0
Australian Catholic University
Country [1] 312699 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
1100 Nudgee Road, Banyo QLD 4014
Country
Australia
Secondary sponsor category [1] 314315 0
None
Name [1] 314315 0
Address [1] 314315 0
Country [1] 314315 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311999 0
Australian Catholic University HREC
Ethics committee address [1] 311999 0
Ethics committee country [1] 311999 0
Australia
Date submitted for ethics approval [1] 311999 0
03/11/2022
Approval date [1] 311999 0
Ethics approval number [1] 311999 0

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

Contacts
Principal investigator
Name 123122 0
Prof Shona Halson
Address 123122 0
Australian Catholic University
1100 Nudgee Road, Banyo QLD 4014
Country 123122 0
Australia
Phone 123122 0
+61 422224491
Fax 123122 0
Email 123122 0
[email protected]
Contact person for public queries
Name 123123 0
Carissa Gardiner
Address 123123 0
Australian Catholic University
1100 Nudgee Road, Banyo QLD 4014
Country 123123 0
Australia
Phone 123123 0
+61 439833967
Fax 123123 0
Email 123123 0
[email protected]
Contact person for scientific queries
Name 123124 0
Carissa Gardiner
Address 123124 0
Australian Catholic University
1100 Nudgee Road, Banyo QLD 4014
Country 123124 0
Australia
Phone 123124 0
+61 439833967
Fax 123124 0
Email 123124 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17668Ethical approval  [email protected]



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.