Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000020482
Ethics application status
Approved
Date submitted
16/12/2015
Date registered
14/01/2016
Date last updated
14/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep-wake cycle and circadian profiles of inpatients admitted to a young adult mental health service
Scientific title
Sleep-wake cycle and circadian profiles of inpatients admitted to a young adult mental health service
Secondary ID [1] 288170 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood Disorder 297075 0
Anxiety Disorder 297076 0
Psychotic Disorder 297077 0
Condition category
Condition code
Mental Health 297311 297311 0 0
Depression
Mental Health 297312 297312 0 0
Anxiety
Mental Health 297313 297313 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Sleep-wake and circadian monitoring for a maximum of 14 days. Participants fill out a sleep log (taking less than 5 minutes per day) each day, and wear an actigraphy recording device (watch-like device) on their wrist for the whole monitoring period (except when swimming/showering).
Intervention code [1] 293474 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296881 0
Characterize sleep-wake profiles of young inpatients with mental disorders by examining sleep timing/amount measures and from actigraphy and sleep diary.
Timepoint [1] 296881 0
Up to 14 days during inpatient admission
Primary outcome [2] 297017 0
Characterize circadian profiles of young inpatients with mental disorders by examining 24 hr activity data from actigraphy.
Timepoint [2] 297017 0
Up to 14 days during inpatient admission
Secondary outcome [1] 319600 0
Investigate how sleep-wake and circadian parameters relate to clinical symptoms across the course of admission by comparison of clinical symptom scales measured at admission and actigraphy and sleep log data.
Timepoint [1] 319600 0
Clinical symptoms measured on admission, sleep-wake and circadian parameters measured over up to 14 days during inpatient admission

Eligibility
Key inclusion criteria
1. Admitted to a Young Adult Mental Health Service
2. Age range: 16 and 30 years of age
3. Disease status: diagnosis of anxiety, mood or psychotic disorder
4. Willingness to give written informed consent and willingness to participate to and comply with the study
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Insufficient English skills
2. Deemed unable to provide informed consent by the admitting clinician

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292569 0
Self funded/Unfunded
Name [1] 292569 0
None
Country [1] 292569 0
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW, 2006
Country
Australia
Secondary sponsor category [1] 291293 0
None
Name [1] 291293 0
N/A
Address [1] 291293 0
N/A
Country [1] 291293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294048 0
St Vincent's Private Hospital Human Research Ethics Commitee
Ethics committee address [1] 294048 0
Level 6, de Lacy Building
St Vincent't Hospital Sydney
390 Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 294048 0
Australia
Date submitted for ethics approval [1] 294048 0
01/09/2014
Approval date [1] 294048 0
20/07/2015
Ethics approval number [1] 294048 0
14/216

Summary
Brief summary
Sleep and circadian disturbances are intricately linked to the onset, co-morbidity and chronicity of various mental disorders. For instance, shortened or extended sleep duration, increased sleep fragmentation and delayed and disorganized sleep-wake schedules have been observed in young people with a range of affective and psychotic disorders. Increasing evidence suggests that changes in sleep and circadian rhythms may modulate the trajectory of mental disorders and treatment outcomes, but little is currently known about sleep and circadian rhythms during critical mental illness episodes leading to hospitalization and how this may relate to the recovery process. The current observational study will use novel ambulatory devices to monitor sleep, general activity levels, body
temperature and ambient light exposure across multiple days in inpatients admitted to a young adult mental health service. Potential associations between sleep-wake and circadian parameters and changes in self-reported clinical symptoms measured across the course of hospitalization will also be investigated. This study has the potential to deepen our understanding of sleep and circadian disturbances in acute phases of mental disorders and how they relate to the recovery process.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62250 0
Prof Ian Hickie
Address 62250 0
Brain and Mind Centre
94 Mallett St
Camperdown
NSW 2050
Country 62250 0
Australia
Phone 62250 0
+61 2 9351 0810
Fax 62250 0
+61 2 9351 0652
Email 62250 0
[email protected]
Contact person for public queries
Name 62251 0
Ian Hickie
Address 62251 0
Brain and Mind Centre
94 Mallett St
Camperdown
NSW 2050
Country 62251 0
Australia
Phone 62251 0
+61 2 9351 0810
Fax 62251 0
Email 62251 0
[email protected]
Contact person for scientific queries
Name 62252 0
Ian Hickie
Address 62252 0
Brain and Mind Centre
94 Mallett St
Camperdown
NSW 2050
Country 62252 0
Australia
Phone 62252 0
+61 2 9351 0810
Fax 62252 0
Email 62252 0
[email protected]

No information has been provided regarding IPD availability


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.