Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000123246
Ethics application status
Approved
Date submitted
12/01/2009
Date registered
20/02/2009
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of restorative sleep on the predisposition towards insulin resistance and diabetes: “The catch-up study”
Scientific title
The effect of restorative sleep on the predisposition towards insulin resistance and diabetes in healthy volunteers between aged 18 and 50: "The catch-up study"
Secondary ID [1] 253488 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep restriction 4183 0
Diabetes 4184 0
Condition category
Condition code
Metabolic and Endocrine 4393 4393 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lengthened sleep - sleeping 10 hours per night from Fri until Monday morning
Restricted sleep - sleeping the same as they would during the week
Obliterating Slow Wave Sleep - using acoustic stimuli during the sleep period. Acoustic stimuli will consist of intermittent tones delivered through loudspeakers in the particpant's bedrooom. Obliterating slow wave sleep condition - sleeping 10 hours per night from Friday until Monday morning.
Duration of each condition - One weekend of testing from Friday night until Monday morning.
Each participant will only undertake 2 of the 3 conditions. They will be randomised to the conditions.
Crossover study. Duration of the 'washout' period - A minimum of 3 weeks.
Intervention code [1] 3902 0
Other interventions
Comparator / control treatment
Each individual shall be their own control, as they will be tested under 2 different conditions
Control group
Active

Outcomes
Primary outcome [1] 5271 0
Insulin sensitivity. It shall be tested by oral glucose tolerance test.
Timepoint [1] 5271 0
After a weekend of a particular sleep condition. Immediately after waking on Monday morning.
Secondary outcome [1] 8883 0
Neurocognitive tests & driving simulation. Measured by standard computerised testing
Timepoint [1] 8883 0
Each day during the weekend of a particular sleep condition
Secondary outcome [2] 8884 0
Blood hormone & cardiovascular markers. Blood sampling
Timepoint [2] 8884 0
After a weekend of a particular sleep condition. Immediately after waking on Monday morning.
Secondary outcome [3] 8885 0
Blood pressure. Measured by standard sphyngomanometry.
Timepoint [3] 8885 0
Multiple measurements over the study period. At least twice a day during the weekend study period and at the screening visit.
Secondary outcome [4] 8886 0
Arterial stiffness by pulse wave analysis
Timepoint [4] 8886 0
After a weekend of a particular sleep condition. Immediately after waking on Monday morning.
Secondary outcome [5] 276476 0
Polysomnography- sleep variables and characteristics
Timepoint [5] 276476 0
Each night during the weekend of a particular sleep condition
Secondary outcome [6] 276477 0
Quailty of life questionnaire
Timepoint [6] 276477 0
Each weekend of a particular sleep condition
Secondary outcome [7] 276478 0
Continuous glucose monitoring using subcutaneous glucose monitoring system
Timepoint [7] 276478 0
For one week at home, prior to weekend study visit
Secondary outcome [8] 276479 0
Sleep questionnaires
Timepoint [8] 276479 0
Several times each day over the weekend of a particular sleep condition
Secondary outcome [9] 276480 0
Activity questionnaire
Timepoint [9] 276480 0
Each weekend of a particular sleep condition
Secondary outcome [10] 276481 0
Hunger questionnaires
Timepoint [10] 276481 0
Each day over the weekend of a particular sleep condition

Eligibility
Key inclusion criteria
Males between 18-50
Chronic intermittent sleep restriction
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diabetics
Any other sleep disorder
Shift workers
Time zone travel in preceding month
Psychiatric disorders or drug abuse, including alcohol
Use of sedatives or antidepressants
Chronic medical conditions likely to interfere with or influence study or the safety of the study, unless well controlled
Unable to restrict caffeine/alcohol during study duration

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)
Allocation will be by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by computer generated randomisation in blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2009
Actual
20/02/2009
Date of last participant enrolment
Anticipated
Actual
7/02/2012
Date of last data collection
Anticipated
Actual
6/04/2012
Sample size
Target
18
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4364 0
University
Name [1] 4364 0
Sydney University
Country [1] 4364 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
PO Box M77
Missenden Road
NSW 2050
Country
Australia
Secondary sponsor category [1] 3931 0
None
Name [1] 3931 0
None
Address [1] 3931 0
None
Country [1] 3931 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6414 0
South West Area Health Service - Concord Zone
Ethics committee address [1] 6414 0
Ethics committee country [1] 6414 0
Australia
Date submitted for ethics approval [1] 6414 0
Approval date [1] 6414 0
18/12/2008
Ethics approval number [1] 6414 0
HREC 08/CRGH/184

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

Contacts
Principal investigator
Name 35080 0
A/Prof Peter Liu
Address 35080 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Road, NSW 2050
Country 35080 0
Australia
Phone 35080 0
+61291140007
Fax 35080 0
Email 35080 0
[email protected]
Contact person for public queries
Name 12427 0
Dr Roo Killick
Address 12427 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Road, NSW 2050
Country 12427 0
Australia
Phone 12427 0
+612 9114 0499
Fax 12427 0
+612 9114 0014
Email 12427 0
[email protected]
Contact person for scientific queries
Name 3355 0
A/Prof Peter Liu
Address 3355 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Road, NSW 2050
Country 3355 0
Australia
Phone 3355 0
+612 9114 0007
Fax 3355 0
+612 9114 0014
Email 3355 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?
Individual participant underlying published results only.
When will data be available (start and end dates)?
Data will be made available upon request, after publication, with no end date determined.
Available to whom?
Data will be made available upon request, after publication and will be determined upon negotiation with researchers who provided a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Secure data transfer and signed data access agreement. Contact: [email protected]


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
SourceTitleYear of PublicationDOI
EmbaseMetabolic and hormonal effects of 'catch-up' sleep in men with chronic, repetitive, lifestyle-driven sleep restriction.2015https://dx.doi.org/10.1111/cen.12747
N.B. These documents automatically identified may not have been verified by the study sponsor.