Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000049875
Ethics application status
Approved
Date submitted
22/11/2011
Date registered
11/01/2012
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results information initially provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Insomnia 100 sleep study: Profiling of Insomnia disorder in a sample of 100 participants
Scientific title
Profiling of Insomnia disorder in a sample of 100 participants
Secondary ID [1] 273430 0
Nil
Universal Trial Number (UTN)
U1111-1125-9767
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder 279214 0
Condition category
Condition code
Mental Health 279422 279422 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
This study consists of two visits to the Woolcock institute. One for screening / consent lasting an hour where the participants will be given an actiwatch and sleep diary to complete for two weeks. After this period, the participant will attend an overnight routine sleep assessment again at the Woolcock institute this will last no longer than 12 hours. After this the study will end. Actiwatch and Diaries. The actiwatch looks like a conventional wrist watch and is used to objectively assess sleep and wake activity, while the diaries contain questions relating to sleep quality, subjective sleepiness and drug accountability. Both are to be used by the patient at home for one week prior to the routine overnight visit. Questionnaires. These will be used at each visit to assess subjective sleepiness, quality of sleep, quality of life, depression and investigator’s overall impression of the status of the patient. These will take approximately 45 min to complete. Routine Diagnostic Polysomnographic Sleep Study. The patient will spend a night in the sleep laboratory at the Woolcock Institute for Medical Research for a routine diagnostic sleep study. This will determine the status of their sleep in general and if they suffer from any potential comorbid conditions. A small amount of blood will be taken as well to check liver function and a full blood count. This will take twelve hours. Neurocognitive test battery. A computer based battery of tests will be administered during the routine overnight sleep study. This will consist of short tests assessing attention & cognitive function. All together, these tests will take approximately one hour. After the study, participants with insomnia will be offered to complete a course in cognitive behavioural therapy for insomnia (CBT-I) as a thank you for completing the study. They will have the choice of internet based CBT-I with six online sessions to address worries and anxieties about sleeping, relaxation techniques, sleep hygiene procedures, and sleep scheduling involving stimulus control and sleep restriction therapy. Each session will take approximately an hour to complete over six weeks. The website is completely interactive and moderated by a team of psychologists. Alternatively, participants may enroll into a insomnia CBT-I workshop with a psychologist that also involves 5 hour long sessions (1 hour per session over 10 weeks) to address worries and anxieties about sleeping, relaxation techniques, sleep hygiene procedures, and sleep scheduling involving stimulus control and sleep restriction therapy for insomnia. At the end of both interventions, participants will have their insomnia severity index score re-examined.
Intervention code [1] 283762 0
Not applicable
Intervention code [2] 285189 0
Behaviour
Comparator / control treatment
Comparison will be made within different subtypes of insomnia disorder sufferers (sleep onset insomnia, sleep maintenance insomnia, early morning awakenings insomnia, and mixed insomnia).
Control group
Active

Outcomes
Primary outcome [1] 285992 0
The primary objective of this study is to determine whether there are observable physiological and neurocognitive differences within different subtypes of insomnia disorder sufferers (sleep onset insomnia, sleep maintenance insomnia, early morning awakenings insomnia, and mixed insomnia).
Timepoint [1] 285992 0
During the 12 hour overnight sleep assessment
Secondary outcome [1] 294911 0
To investigate potential correlations between questionnaire response data and overnight sleep study results with regards to insomnia sub-type. Allowing us to further understand the differences within subtypes of insomnia disorder.
Timepoint [1] 294911 0
During the 12 hour overnight sleep assessment
Secondary outcome [2] 298215 0
Predictors of treatment success: we will evaluate which subtypes of insomnia respond best to treatment by correlating their treatment outcome with their insomnia subtype.
Timepoint [2] 298215 0
Post treatment

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
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active illicit substance use or alcohol dependence
2. Psychiatric disorders, other than mild to moderate depression (on the Depression Anxiety Stress Scales)
3. Previous history of depressive episode
4. Sleep disorders (other than insomnia)
5. Learning disabilities
6. Dementia
7. Neurological problems
8. Pregnancy or lactation

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
29/02/2012
Date of last participant enrolment
Anticipated
Actual
2/08/2014
Date of last data collection
Anticipated
Actual
29/08/2014
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284239 0
University
Name [1] 284239 0
University of Sydney
Country [1] 284239 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
CIRUS
PO BOX M77
Missenden Rd
Sydney
2050 NSW
Country
Australia
Secondary sponsor category [1] 269195 0
None
Name [1] 269195 0
Address [1] 269195 0
Country [1] 269195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286204 0
Sydney Local Health District Ethics Review Committee
Ethics committee address [1] 286204 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 286204 0
Australia
Date submitted for ethics approval [1] 286204 0
23/11/2011
Approval date [1] 286204 0
20/01/2012
Ethics approval number [1] 286204 0

Summary
Brief summary
To discover and profile the biological mechanisms within Insomnia. This will be achieved by sampling a large number of sufferers and examining them overnight through a clinical sleep study.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 33420 0
Dr Christopher Miller
Address 33420 0
Woolcock Institute of Medical Research
PO Box M77, Missenden Road, NSW, 2050
Camperdown
Country 33420 0
Australia
Phone 33420 0
+61291140411
Fax 33420 0
Email 33420 0
[email protected]
Contact person for public queries
Name 16667 0
Christopher Miller
Address 16667 0
Woolcock Institute of Medical Research
431 Glebe Point Road,
Glebe
Sydney
NSW 2037
Country 16667 0
Australia
Phone 16667 0
+61 (2) 9114 0411
Fax 16667 0
+ 61 2 9114 0014
Email 16667 0
[email protected]
Contact person for scientific queries
Name 7595 0
Delwyn Bartlett
Address 7595 0
Woolcock Institute of Medical Research
431 Glebe Point Road,
Glebe
Sydney
NSW 2037
Country 7595 0
Australia
Phone 7595 0
+61 2 9114 0460
Fax 7595 0
+ 61 2 9114 0014
Email 7595 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 01 November 2016 https://doi.org/10.5665/sleep.623... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhysiological Markers of Arousal Change with Psychological Treatment for Insomnia: A Preliminary Investigation.2015https://dx.doi.org/10.1371/journal.pone.0145317
EmbaseClusters of insomnia disorder: An exploratory cluster analysis of objective sleep parameters reveals differences in neurocognitive functioning, quantitative EEG, and heart rate variability.2016https://dx.doi.org/10.5665/sleep.6230
N.B. These documents automatically identified may not have been verified by the study sponsor.