Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000050853
Ethics application status
Approved
Date submitted
21/11/2011
Date registered
11/01/2012
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
Insomnia Magnetic Resonance Spectroscopy (MRS) imaging sleep study
Scientific title
An Magnetic Resonance Spectroscopy (MRS) study of the brain in insomnia disorder
Secondary ID [1] 273419 0
Nil
Universal Trial Number (UTN)
U1111-1125-9591
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder 279208 0
Condition category
Condition code
Mental Health 279414 279414 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Magnetic Resonance Spectroscopy (MRS) brain imaging will be used in this study. This involves an hour long brain imaging scan that will be used to examine brain neurochemistry within insomnia sufferers. The overall experiment will take three hours to complete.

Participants will be grouped according to responses provided on the hyperarousal questionnaire - with those high on this scale being included in the insomnia with hyperarousal group. A control group will also be determined by this scale. Those who have insomnia but a low score on the hyperarousal scale will be included as controls.
Intervention code [1] 283755 0
Not applicable
Comparator / control treatment
Insomnia Disorder without 'hyperarousal'
Control group
Active

Outcomes
Primary outcome [1] 285984 0
To use MRS in order to compare and contrast brain neurochemistry within specific and highly defined insomnia sub types (insomnia sufferers with and without hyperarousal).
Timepoint [1] 285984 0
A comparison will be made between controls and insomnia sufferers with hyperarousal. This will take place at one time point only.
Secondary outcome [1] 294897 0
Nil
Timepoint [1] 294897 0
Nil

Eligibility
Key inclusion criteria
1. Symptoms of Insomnia Disorder as diagnosed by the Diagnostic and
Statistical Manual of Mental Disorders, Fifth Edition criteria for insomnia
disorder (APA, 2013) specifically: Difficulty initiating or maintaining sleep or
waking up too early for at least 3 nights per week, for at least 3 months,
with adequate opportunity and circumstances for sleep
2. Stable sleep/wake schedule with no shift work
3. Able to give informed, written consent
4. Fluent speaker of English
5. Referred by a sleep physician to have a routine sleep study as part of Medicare
Minimum age
23 Years
Maximum age
56 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnancy or lactation
2. Active illicit substance use or alcohol/caffeine dependence
3. Medications that interfere with sleep (within 1 month of assessment)
4. Psychiatric disorders, other than mild to moderate depression (on the
Depression Anxiety Stress Scales)
5. Another sleep disorder evaluated by a Sleep Physician / Sleep
Psychologist that better explains the complaint of sleep loss.
6. Severe cognitive impairment that does not allow patients to consent or
follow study instructions
7. Overnight shift workers and recent time-zone travel (within last 2
months)
8. Actively treated sleep disorder (e.g. CPAP/CBT-I)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
2/07/2012
Date of last participant enrolment
Anticipated
Actual
19/12/2014
Date of last data collection
Anticipated
Actual
19/03/2015
Sample size
Target
47
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284232 0
University
Name [1] 284232 0
University of Sydney
Country [1] 284232 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 269188 0
Charities/Societies/Foundations
Name [1] 269188 0
Woolcock Institute of Medical Research
Address [1] 269188 0
431 Glebe Point Road, Glebe, NSW 2037
Country [1] 269188 0
Australia
Other collaborator category [1] 260356 0
University
Name [1] 260356 0
The University of New South Wales
Address [1] 260356 0
UNSW Sydney NSW 2052 Australia
Country [1] 260356 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286195 0
Ethics Review Committee
Ethics committee address [1] 286195 0
Ethics committee country [1] 286195 0
Australia
Date submitted for ethics approval [1] 286195 0
23/11/2011
Approval date [1] 286195 0
20/01/2012
Ethics approval number [1] 286195 0

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

Contacts
Principal investigator
Name 33414 0
Prof Ron Grunstein
Address 33414 0
Woolcock Institute of Medical Research PO Box M77, Missenden Road, NSW, 2050 Camperdown
Country 33414 0
Australia
Phone 33414 0
+61291140411
Fax 33414 0
Email 33414 0
[email protected]
Contact person for public queries
Name 16661 0
Delwyn Bartlett
Address 16661 0
431 Glebe Point Road, Glebe, NSW 2037
Country 16661 0
Australia
Phone 16661 0
+61 0291140460
Fax 16661 0
Email 16661 0
[email protected]
Contact person for scientific queries
Name 7589 0
Delwyn Bartlett
Address 7589 0
431 Glebe Point Road, Glebe, NSW 2037
Country 7589 0
Australia
Phone 7589 0
+61 0291140460
Fax 7589 0
Email 7589 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be made available upon request, after publication and will be determined upon negotiation with researchers who provided a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant underlying published results only.

What types of analyses could be done with individual participant data?
• Any purpose.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be made available upon request, after publication, with no end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Secure data transfer and signed data access agreement. Contact: [email protected]


Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.