Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000181606
Ethics application status
Approved
Date submitted
31/01/2023
Date registered
21/02/2023
Date last updated
4/08/2024
Date data sharing statement initially provided
21/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the impact of sleep restriction on reward learning
Scientific title
Examining the impact of sleep restriction on reward learning in healthy adults
Secondary ID [1] 308722 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Digital Rapid Eye Movement Sleep Study (DREM Sleep Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep restriction 328767 0
Condition category
Condition code
Mental Health 325775 325775 0 0
Other mental health disorders
Mental Health 325777 325777 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either sleep restriction or well-rested conditions, for 8 nights of at-home sleep monitoring. Participants in the sleep restriction condition will be expected to keep a regular sleep schedule involving 5hrs/night total time in bed, prescribed by the research team. Participants will be asked to ensure they adhere to the bed and wake times prescribed, and researchers will monitor their adherence each day via the protocols described below.

During the at-home sleep monitoring period, participants will be asked to wear an actigraph/fitbit 24-hours per day (except when engaged in activities that may damage the device). Participants will also be asked to complete a daily sleep diary and call-ins to a designated voicemail system. Call-ins are made day and night as a secondary measure of adherence to the bed and wakes times.

Lastly, participants will be expected to wear an at-home EEG device for 5 nights. To achieve this, participants will be provided with a Dreem headband, which they are expected to wear during their allocated sleep times (5hrs/night). The device is worn on the head during sleep and collects data via 5 EEG sensors (EEG) and a 3-D accelerometer. Participants will attend a 30-min video conference during their at-home monitoring period to discuss how to use the device. They will also be provided with detailed manuals on the device.

On the 7th day of at-home sleep monitoring, participants will complete a battery of reward-based cognitive tasks and questionnaires on their home device.
Intervention code [1] 325262 0
Behaviour
Comparator / control treatment
Participants allocated to the well-rested condition will act as active normal controls. In the well-rested condition, participants will be prescribed 9hrs/night total in bed. Participants will be asked to ensure they adhere to the bed and wake times prescribed, and researchers will monitor their adherence each day via the protocols described below.

During the at-home sleep monitoring period, participants will be asked to wear an actigraph/fitbit 24-hours per day (except when engaged in activities that may damage the device). Participants will also be asked to complete a daily sleep diary and call-ins to a designated voicemail system. Call-ins are made day and night as a secondary measure of adherence to the bed and wakes times.

Lastly, participants will be expected to wear an at-home EEG device for 5 nights. To achieve this, participants will be provided with a Dreem headband, which they are expected to wear during their allocated sleep times (9hrs/night). The device is worn on the head during sleep and collects data via 5 EEG sensors (EEG) and a 3-D accelerometer. Participants will attend a 30-min video conference during their at-home monitoring period to discuss how to use the device. They will also be provided with detailed manuals on the device.

On the 7th day of at-home sleep monitoring, participants will complete a battery of reward-based cognitive tasks and questionnaires on their home device.
Control group
Active

Outcomes
Primary outcome [1] 333617 0
Probabilistic Reward Task - Response Bias

A response bias provides an index of the participants’ systematic preference for the response paired with the more frequent reward.

Timepoint [1] 333617 0
2 Hours Post-intervention
Primary outcome [2] 333618 0
Two-Step Task - Trial-by-Trial Behavioural Adjustment
Behavioural data will examine learning strategies employed, by examining the effects of transition type (common or rare) and reward (reward or no reward) on their subsequent first-stage choices (stay or switch).
Timepoint [2] 333618 0
2 Hours Post-intervention
Primary outcome [3] 333619 0
Monetary Incentive Delay - Reaction Time
Overall mean response latency (in ms) for rewarded vs. non-rewarded trials, and across trials (measure of rate of learning). Response latency will be recorded by the task software.
Timepoint [3] 333619 0
2 Hours Post-intervention
Secondary outcome [1] 417767 0
Probabilistic Reward Task - Reaction Time
Overall mean response latency (in ms) of correct responses - across all test trials, frequently rewarded trials, and infrequently rewarded trials. Response latency will be recorded by the task software.
Timepoint [1] 417767 0
2 Hours Post-intervention
Secondary outcome [2] 417768 0
Probabilistic Reward Task - Discriminability
The discriminability score provides an index of the number of correct responses after presentation of ambiguous cues.
Timepoint [2] 417768 0
2 Hours Post-intervention
Secondary outcome [3] 417769 0
Monetary Incentive Delay -"Hit" Rate
Number of correct responses ("hits") for rewarded trials.
Timepoint [3] 417769 0
2 Hours Post-intervention
Secondary outcome [4] 417770 0
Total Sleep Time (TST)
A measure of total sleep time (hrs) over the night will be derived from sleep diaries, actiwatch/fitbit and EEG devices.
Timepoint [4] 417770 0
Immediately post-intervention and post-testing
Secondary outcome [5] 418642 0
Monetary Incentive Delay -"Hit" Rate
Number of correct responses ("hits") for nonrewarded trials.
Timepoint [5] 418642 0
2 Hours Post-Intervention
Secondary outcome [6] 418643 0
Sleep Efficiency (SE)
A measure of the proportion of total time in bed spent asleep (total sleep duration / total time in bed; %) will be derived from sleep diaries, actiwatch/fitbit and EEG devices.
Timepoint [6] 418643 0
Immediately post-intervention and post-testing
Secondary outcome [7] 418644 0
Sleep Stage Percentage
A measure of the proportion of the total sleep time that is spent in each sleep stage (stage of sleep duration / total sleep duration; %) will be derived from sleep diaries, actiwatch/fitbit and EEG devices.
Timepoint [7] 418644 0
Immediately post-intervention and post-testing
Secondary outcome [8] 418645 0
Sleep Stage Latency
A measure of the duration of sleep before the 1st onset of a particular sleep stage (mins/hrs) will be derived from sleep diaries, actiwatch/fitbit and EEG devices.
Timepoint [8] 418645 0
Immediately post-intervention and post-testing
Secondary outcome [9] 418646 0
Sleep stage duration
A measure of the duration of each sleep stage (mins/hrs) will be derived from sleep diaries, actiwatch/fitbit and EEG devices.
Timepoint [9] 418646 0
Immediately post-intervention and post-testing

Eligibility
Key inclusion criteria
- Healthy adults
- Aged between 18-39 years
- Fluent in English
Minimum age
18 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any history or current serious medical (e.g., autoimmune disorders, inflammatory disorders, epilepsy, migraine, neurological disorders, colour blindness, eye disorders/diseases, or cancer), sleep, or psychiatric diagnoses
- Family history of mood or psychotic disorders
- Atypical sleep schedule (defined as a regular bedtime NOT between 10pm-12:30am or wake time NOT between 6am and 9am or a total sleep time more than 9 hours or less than 7 hours).
- A current or past smoker (within last year)
- Any illicit/recreational use of drug or medications (including prescription medications used outside of the prescribed use) within the past 3 months
- Taking psychotropic (anti-depressants, antipsychotics, and mood stabilisers), sleep or pain medications
- A moderate to severe traumatic brain injury (i.e., head injury accompanied by loss of
consciousness > 30 minutes and/or altered mental state > 24 hours)
- An average daily consumption of more than 400mg caffeine within the past 3 months.
- An average weekly consumption of more than 10 standard alcoholic drinks per week or more than 6 drinks per day, within the past 3 months.
- Any shift work within the past 3 months, defined as any work undertaken after 10pm and/or before 6am
- A BMI of <18.5 or >30
- Insufficient fluency in English to understand tasks and questionnaires
- No computer/laptop or internet connection to complete remote cognitive testing

Study design
Purpose of the study
Prevention
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)
Block randomisation using a computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/07/2022
Date of last participant enrolment
Anticipated
25/12/2023
Actual
4/12/2023
Date of last data collection
Anticipated
1/01/2024
Actual
5/12/2023
Sample size
Target
70
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312946 0
University
Name [1] 312946 0
Monash University
Country [1] 312946 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University,
Clayton Campus, Wellington Road,
Clayton, Victoria 3800
Country
Australia
Secondary sponsor category [1] 314717 0
None
Name [1] 314717 0
Address [1] 314717 0
Country [1] 314717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312219 0
Monash University Human Research Ethics Committees (MUHREC)
Ethics committee address [1] 312219 0
Ethics committee country [1] 312219 0
Australia
Date submitted for ethics approval [1] 312219 0
30/05/2022
Approval date [1] 312219 0
07/06/2022
Ethics approval number [1] 312219 0

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

Contacts
Principal investigator
Name 123890 0
Prof Sean P. A. Drummond
Address 123890 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton, VIC 3800
Country 123890 0
Australia
Phone 123890 0
+61 3 9905 3956
Fax 123890 0
Email 123890 0
[email protected]
Contact person for public queries
Name 123891 0
Eleni Kavaliotis
Address 123891 0
Turner Clinics
Monash University
1/270 Ferntree Gully Road
Notting Hill VIC 3168
Country 123891 0
Australia
Phone 123891 0
+61 3 9905 5908
Fax 123891 0
Email 123891 0
[email protected]
Contact person for scientific queries
Name 123892 0
Eleni Kavaliotis
Address 123892 0
Turner Clinics
Monash University
1/270 Ferntree Gully Road
Notting Hill VIC 3168
Country 123892 0
Australia
Phone 123892 0
+61 3 9905 5908
Fax 123892 0
Email 123892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographic information, questionnaire and sleep data collected during at-home monitoring, and cognitive task data. Data will be shared in a de-identified manner.
When will data be available (start and end dates)?
Data underlying each manuscript will be made available following publication of that manuscript. All other data will be made available 36 months after the end of the trial. No end date is yet determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
No limits
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Prof. Sean P.A. Drummond - [email protected]). The data will be placed on a Monash University sponsored data repository.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18093Ethical approval    385208-(Uploaded-23-01-2023-12-59-30)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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