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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]

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

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

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]

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]

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]

2 Hours Post-intervention

Primary outcome [2]

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]

2 Hours Post-intervention

Primary outcome [3]

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]

2 Hours Post-intervention

Secondary outcome [1]

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]

2 Hours Post-intervention

Secondary outcome [2]

Probabilistic Reward Task - Discriminability
The discriminability score provides an index of the number of correct responses after presentation of ambiguous cues.

Timepoint [2]

2 Hours Post-intervention

Secondary outcome [3]

Monetary Incentive Delay -"Hit" Rate
Number of correct responses ("hits") for rewarded trials.

Timepoint [3]

2 Hours Post-intervention

Secondary outcome [4]

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]

Immediately post-intervention and post-testing

Secondary outcome [5]

Monetary Incentive Delay -"Hit" Rate
Number of correct responses ("hits") for nonrewarded trials.

Timepoint [5]

2 Hours Post-Intervention

Secondary outcome [6]

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]

Immediately post-intervention and post-testing

Secondary outcome [7]

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]

Immediately post-intervention and post-testing

Secondary outcome [8]

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]

Immediately post-intervention and post-testing

Secondary outcome [9]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Monash University,
Clayton Campus, Wellington Road,
Clayton, Victoria 3800

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Monash University,
Clayton Campus, Wellington Road,
Clayton, Victoria 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committees (MUHREC)

Ethics committee address [1]

First Floor, Room 111 Chancellery Building E 24 Sports Walk Monash Research Office Clayton Campus, Monash University VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/05/2022

Approval date [1]

07/06/2022

Ethics approval number [1]

Summary

Brief summary

A disruption in reward processing is suggested to underpin a number of mental health disorders. Current evidence indicates alterations in brain regions during the anticipation and receipt of reward characterise individuals with eating-related disorders (e.g., obesity, binge-eating), non-substance addictions and substance use disorders. These alterations may facilitate compulsive behaviours and potentiate craving. Current evidence suggests reward processing is also impaired in conditions of sleep disruption, with a number of studies indicating impaired ability to discriminate between reward and punishment and increased reward-driven approach behaviour following sleep deprivation. Given an increasing number of individuals in today’s society function without adequate sleep this may indicate a role for sleep disruption in the development and maintenance of disorders characterised by disrupted reward-processing. This study aims to assess the mechanisms through which reward learning and appetitive behaviour could be impacting on clinical populations via sleep. We hypothesise adults who undergo sleep restriction (prescribed a 5 hour sleep opportunity), relative to well rested adults (prescribed an 9 hour sleep opportunity), will have disrupted reward learning. Furthermore, we hypothesise key sleep stages, particularly REM sleep parameters (e.g., percentage, duration, onset latency, etc.), will mediate the relationship between sleep restriction and poor reward learning.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sean P. A. Drummond

Address

Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton, VIC 3800

Country

Australia

Phone

+61 3 9905 3956

Fax

sean.drummond@monash.edu

Contact person for public queries

Name

Eleni Kavaliotis

Address

Turner Clinics
Monash University
1/270 Ferntree Gully Road
Notting Hill VIC 3168

Country

Australia

Phone

+61 3 9905 5908

Fax

eleni.kavaliotis@monash.edu

Contact person for scientific queries

Name

Eleni Kavaliotis

Address

Turner Clinics
Monash University
1/270 Ferntree Gully Road
Notting Hill VIC 3168

Country

Australia

Phone

+61 3 9905 5908

Fax

eleni.kavaliotis@monash.edu

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 - sean.drummond@monash.edu). The data will be placed on a Monash University sponsored data repository.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18093	Ethical approval					385208-(Uploaded-23-01-2023-12-59-30)-Study-related document.pdf

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