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Trial registered on ANZCTR

Registration number

ACTRN12621001625864

Ethics application status

Approved

Date submitted

24/10/2021

Date registered

29/11/2021

Date last updated

28/01/2024

Date data sharing statement initially provided

29/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

The Dose and Timing Relationship Between Caffeine and Subsequent Sleep Quantity and Quality

Scientific title

The Dose and Timing Relationship Between Caffeine and Subsequent Sleep Quantity and Quality in Healthy Adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sleep

Condition category

Condition code

Public Health

Other public health

Neurological

Studies of the normal brain and nervous system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention is the administration of caffeine to be taken orally in capsule form. The study is a crossover design where each participant will be randomly exposed to all seven conditions organised using a Latin Square design. Each condition will be separated by a 2 day washout period. Conditions include;
Placebo
100mg administered 12 hours prior to bedtime
100mg administered 8 hours prior to bedtime
100mg administered 4 hours prior to bedtime
400mg administered 12 hours prior to bedtime
400mg administered 8 hours prior to bedtime
400mg administered 4 hours prior to bedtime
Participants will consume three capsules on each experimental day at 12, 8 and 4 hours prior to bedtime. The caffeine capsule will be administered at the timepoint and dose relevant to the condition with the remaining two capsules containing the placebo. All three capsules will contain the placebo for the placebo condition.
Saliva samples will be collected using cotton chew swabs to monitor caffeine concentrations and compliance. These will occur on experimental days at 11, 7 and 3 hours prior to bedtime, 5 minutes prior to bedtime and 5 minutes after waking.

Intervention code [1]

Lifestyle

Intervention code [2]

Treatment: Other

Comparator / control treatment

Glucose will be administered as the placebo control in identical appearing capsule form

Control group

Placebo

Outcomes

Primary outcome [1]

Total sleep time (min)

Timepoint [1]

Recorded for duration of overnight sleep bout commencing 4 hours after last capsule consumption. This will be 12, 8 or 4 hours after caffeine consumption depending on the given condition. Measures will be recorded using partial polysomnography.

Primary outcome [2]

Sleep efficiency (%)

Timepoint [2]

Primary outcome [3]

Sleep onset latency (min)

Timepoint [3]

Secondary outcome [1]

Salivary caffeine concentration (µg/mL)

Timepoint [1]

Saliva collections will be completed 1 hour after each capsule administration. Capsule administration will occur at 12, 8 and 4 hours prior to bedtime therefore saliva collections will occur at 11, 7 and 3 hours prior to bedtime. Additionally, samples will be taken 5 minutes prior to bedtime and 5 minutes after waking.

Secondary outcome [2]

Subjective level of alertness (1-10 Likert scale)

Timepoint [2]

Assessed immediately prior to bedtime - this will be 4 hours after the last capsule is consumed. Depending on the condition, it will be 12, 8 or 4 hours post caffeine consumption.

Secondary outcome [3]

Wake after sleep onset (min)
(Primary Outcome)

Timepoint [3]

Secondary outcome [4]

Relative percentage of time in each sleep stage (1,2,3 or REM)
(Primary Outcome)

Timepoint [4]

Secondary outcome [5]

Subjective sleep quality
(Primary Outcome)

Timepoint [5]

Assessed using a questionnaire with a modified 1-5 Likert scale completed immediately upon waking in the morning

Eligibility

Key inclusion criteria

Apparently healthy male aged between 18 and 40 years of age
No reported medical or sleep condition
Daily habitual caffeine consumption <300mg

Minimum age

18 Years

Maximum age

40 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

BMI <18kg/m2 or >26kg/m2
Consumed cigarettes, drugs or medications known to affect sleep in the 3 months prior to study admission
Undertaken shift work or transmeridian travel in the 3 months 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

Completed

Date of first participant enrolment

Anticipated

1/02/2022

Actual

3/06/2022

Date of last participant enrolment

Anticipated

Actual

28/02/2023

Date of last data collection

Anticipated

Actual

27/06/2023

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

1100 Nudgee Road, Banyo QLD 4014

Country [1]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

1100 Nudgee Road, Banyo QLD 4014

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University Human Research Ethics Committee

Ethics committee address [1]

Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/10/2021

Approval date [1]

01/02/2022

Ethics approval number [1]

Summary

Brief summary

This research project is investigating if the amount of caffeine and the time that it is consumed during the day changes the quantity and quality of night-time sleep. The project will involve a low (100mg) and high (400mg) dose of caffeine administered in the morning, afternoon and evening to find out if the effect on sleep changes. Given caffeine is a stimulant, it is expected that sleep will be influenced when more caffeine is consumed closer to bedtime. By investigating different dose and timing combinations, we are aiming to determine if there is a cut-off time for consuming caffeine to avoid poor sleep. This is important as poor sleep is associated with an increased risk of illness, accidents and injuries.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Shona Halson

Address

Australian Catholic University
1100 Nudgee Road, Banyo QLD 4014

Country

Australia

Phone

+61 422 224 491

Fax

[email protected]

Contact person for public queries

Name

Carissa Gardiner

Address

Australian Catholic University
1100 Nudgee Road, Banyo QLD 4014

Country

Australia

Phone

+61 439 833 967

Fax

[email protected]

Contact person for scientific queries

Name

Carissa Gardiner

Address

Australian Catholic University
1100 Nudgee Road, Banyo QLD 4014

Country

Australia

Phone

+61 439 833 967

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13744	Ethical 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.

Trial Review

Documents added manually

Documents added automatically