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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
15/03/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Insomnia Magnetic Resonance Spectroscopy (MRS) imaging sleep study
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Scientific title
An Magnetic Resonance Spectroscopy (MRS) study of the brain in insomnia disorder
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Secondary ID [1]
273419
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Nil
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Universal Trial Number (UTN)
U1111-1125-9591
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder
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Condition category
Condition code
Mental Health
279414
279414
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0
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Other mental health disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
283755
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Not applicable
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Comparator / control treatment
Insomnia Disorder without 'hyperarousal'
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Control group
Active
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Outcomes
Primary outcome [1]
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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).
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Timepoint [1]
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A comparison will be made between controls and insomnia sufferers with hyperarousal. This will take place at one time point only.
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Secondary outcome [1]
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Nil
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Timepoint [1]
294897
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Nil
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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
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Minimum age
23
Years
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Maximum age
56
Years
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Gender
Both males and females
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Can healthy volunteers participate?
Yes
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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)
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2012
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Actual
2/07/2012
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Date of last participant enrolment
Anticipated
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Actual
19/12/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
47
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Accrual to date
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Final
47
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Sydney
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Address [1]
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The University of Sydney
NSW 2006
Australia
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Country [1]
284232
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
The University of Sydney
NSW 2006
Australia
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Country
Australia
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Secondary sponsor category [1]
269188
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Charities/Societies/Foundations
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Name [1]
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Woolcock Institute of Medical Research
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Address [1]
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431 Glebe Point Road,
Glebe, NSW 2037
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Country [1]
269188
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Australia
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Other collaborator category [1]
260356
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University
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Name [1]
260356
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The University of New South Wales
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Address [1]
260356
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UNSW Sydney NSW 2052 Australia
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Country [1]
260356
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
286195
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Ethics Review Committee
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Ethics committee address [1]
286195
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c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
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Ethics committee country [1]
286195
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Australia
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Date submitted for ethics approval [1]
286195
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23/11/2011
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Approval date [1]
286195
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20/01/2012
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Ethics approval number [1]
286195
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Summary
Brief summary
The objective is to investigate whether there are differences between insomnia sufferers who have a specific type of insomnia (hyperarousal insomnia) and those who suffer from general insomnia but do not have elements of hyperarousal. As a result, this study will use a brain imaging technique called Magnetic resonance spectroscopy (MRS) in order to attempt to find differences in brain neurochemistry between these two different types of insomnia sufferers.
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Trial website
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Trial related presentations / publications
No citations are available so far.
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Public notes
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Contacts
Principal investigator
Name
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Prof Ron Grunstein
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Address
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Woolcock Institute of Medical Research
PO Box M77, Missenden Road, NSW, 2050
Camperdown
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Country
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Australia
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Phone
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+61291140411
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Fax
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Email
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ron.grunstein@sydney.edu.au
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Contact person for public queries
Name
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A/Prof Delwyn Bartlett
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Address
16661
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431 Glebe Point Road, Glebe, NSW 2037
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Country
16661
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Australia
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Phone
16661
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+61 0291140460
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Fax
16661
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Email
16661
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delwyn.bartlett@sydney.edu.au
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Contact person for scientific queries
Name
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A/Prof Delwyn Bartlett
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Address
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431 Glebe Point Road, Glebe, NSW 2037
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Country
7589
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Australia
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Phone
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+61 0291140460
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Fax
7589
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Email
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delwyn.bartlett@sydney.edu.au
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No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
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Other publications
Have study results been made publicly available in another format?
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Results – basic reporting
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Results – plain English summary
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