Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000618257
Ethics application status
Approved
Date submitted
13/04/2018
Date registered
20/04/2018
Date last updated
6/05/2021
Date data sharing statement initially provided
6/05/2021
Date results information initially provided
6/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Amyloid deposition and cognitive function in Obstructive Sleep Apnoea
Scientific title
.Amyloid deposition and cognitive function in Obstructive Sleep Apnoea
Secondary ID [1] 294526 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ADiOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 307297 0
Condition category
Condition code
Respiratory 306414 306414 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study group is individuals with moderate to severe obstructive sleep apnoea.

Participants attend 1 x 2.5-hour face-to-face cognitive testing session that is run by a Research Assistant with experience in administering the testing materials . Participants are asked to complete a number of self-report questionnaires and cognitive/mood assessment tasks. Participants undergo 1x 18-F-NAV4694 PET scan to observe the amount of amyloid in the brain. An introvenous line will be inserted into a vein of the arm for the injection of the imaging agent. Participants will rest for 50 minutes and then be positioned lying down with their head in the PET scanner. A 20-minute image will be acquired starting at 50 minutes post injection of the 18F-NAV4694.
Intervention code [1] 300853 0
Early Detection / Screening
Comparator / control treatment
Health individuals with no sleep disorder, age and gender matched.
Control group
Active

Outcomes
Primary outcome [1] 305459 0
Degree of brain beta-amyloid burden as assessed by Positron Emission Tomography imaging.
Timepoint [1] 305459 0
Baseline
Secondary outcome [1] 345304 0
Level of daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS)
Timepoint [1] 345304 0
Baseline
Secondary outcome [2] 345305 0
Cognitive function and mood measured using Mini Mental State Examination
Timepoint [2] 345305 0
Baseline
Secondary outcome [3] 345306 0
Severity of Obstructive Sleep Apnoea (OSA) assessed by Apnoea Hypopnea Index (AHI) result from Sleep Study
Timepoint [3] 345306 0
Screening
Secondary outcome [4] 345673 0
Cognitive function and mood measured using Delis-Kaplan Executive Function System
Timepoint [4] 345673 0
Baseline
Secondary outcome [5] 345674 0
Cognitive function and mood measured using Wechsler Test of Adult Reading
Timepoint [5] 345674 0
Baseline
Secondary outcome [6] 345675 0
Cognitive function and mood measured using WAIS Digit Span
Timepoint [6] 345675 0
Baseline
Secondary outcome [7] 345676 0
Cognitive function and mood measured using Digit Symbol Coding
Timepoint [7] 345676 0
Baseline
Secondary outcome [8] 345677 0
Cognitive function and mood measured using Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Task
Timepoint [8] 345677 0
Baseline
Secondary outcome [9] 345678 0
Cognitive function and mood measured using Autobiographical Memory Test
Timepoint [9] 345678 0
Baseline
Secondary outcome [10] 345679 0
Cognitive function and mood measured using Rey Complex Figure Test
Timepoint [10] 345679 0
Baseline
Secondary outcome [11] 345680 0
Cognitive function and mood measured using Cogstate Battery
Timepoint [11] 345680 0
Baseline
Secondary outcome [12] 345681 0
Cognitive function and mood measured using Hospital Anxiety and Depression Scale
Timepoint [12] 345681 0
Baseline
Secondary outcome [13] 345682 0
Cognitive function and mood measured using Subtle Cognitive Impairment Test
Timepoint [13] 345682 0
Baseline
Secondary outcome [14] 345683 0
Cognitive function and mood measured using Trail Making Test
Timepoint [14] 345683 0
Baseline
Secondary outcome [15] 345684 0
Cognitive function and mood measured using Samn-Perelli Fatigue Scale
Timepoint [15] 345684 0
Baseline
Secondary outcome [16] 345685 0
Cognitive function and mood measured using Geriatric Depression Scale
Timepoint [16] 345685 0
Baseline
Secondary outcome [17] 345686 0
Cognitive function and mood measured using Autobiographical Memory Interview
Timepoint [17] 345686 0
Baseline

Eligibility
Key inclusion criteria
Aged 50-75 years; OSA diagnosis (AHI>15 events/hr); are OSA treatment-naïve; sufficient English to undertake cognitive testing; able to provide informed consent.

Healthy controls will be age- and gender-matched to the OSA group. The will be required to have sufficient English to undertake cognitive testing; able to provide informed consent; must have no sleep disorder (AHI <5 events/hr).
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Active medical or psychiatric condition that may interfere with study procedures; or a previous diagnosis of dementia; pregnancy.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be in the form of independent samples t-tests comparing overall amyloid burden and cognitive function between of the OSA patients and healthy controls. Regression analyses will be conducted to between clinical outcomes (cognition, sleepiness, sleep variables, demographics) and amyloid burden.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
8/12/2016
Date of last participant enrolment
Anticipated
1/04/2019
Actual
12/12/2019
Date of last data collection
Anticipated
28/06/2019
Actual
18/12/2019
Sample size
Target
70
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10622 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 22339 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 299214 0
Charities/Societies/Foundations
Name [1] 299214 0
Institute for Breathing and Sleep
Country [1] 299214 0
Australia
Funding source category [2] 299215 0
Charities/Societies/Foundations
Name [2] 299215 0
Brain Foundation
Country [2] 299215 0
Australia
Funding source category [3] 299216 0
Charities/Societies/Foundations
Name [3] 299216 0
Equity Trustee
Country [3] 299216 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Breathing and Sleep
Address
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 298476 0
None
Name [1] 298476 0
Address [1] 298476 0
Country [1] 298476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300078 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 300078 0
Austin Hospital
145 Studley Rd,
Heidelberg VIC 3084
PO Box 5555 Heidelberg
Ethics committee country [1] 300078 0
Australia
Date submitted for ethics approval [1] 300078 0
Approval date [1] 300078 0
01/07/2016
Ethics approval number [1] 300078 0

Summary
Brief summary
Obstructive Sleep Apnoea (OSA) is a highly prevalent chronic illness, characterised by repetitive collapse of the airway during sleep, causing falls in blood oxygen levels and sleep disruption. OSA is associated with cognitive deficits, especially memory impairments. Another common condition, dementia, is in the top 4 causes of burden of disease of high-income nations. It affects over 340,000 Australians. OSA is common in patients with dementia, with estimates of 38-45% of dementia patients having OSA. The risk of Alzheimer’s disease and vascular dementia has been shown to increase in patients with OSA. However, a direct causal link between these two conditions has not been established.
Beta-amyloid deposits are commonly found in the brains of patients with dementia, and are implicated in the development of dementia. Positron emission tomography (PET) can be used to assess levels of amyloid in the brains of patients, and these levels can be associated with cognitive function. Previous studies performed at Austin Health have found significant associations between amyloid levels and memory impairment in patients with mild cognitive impairment. To date, no studies have examined whether OSA is associated with higher levels of beta amyloid deposits or Alzheimer’s disease -type neural changes, or how these changes relate to cognitive performance.
This study will use PET scanning techniques to examine the levels of amyloid in the brains of patients with OSA, and compare these to brain scans of healthy participants. This study will also conduct cognitive assessments in the OSA patients and healthy controls, examining associations between cognitive performance and amyloid levels.
Identifying potential biomarkers of amyloid burden in OSA could have important implications for early detection and risk assessment. Early identification of the risk of developing dementia in patients with OSA is important as it allows the possibility of a simple intervention that targets the sleep disorder that may be contributing towards the development of neural and cognitive impairment, before it progresses to dementia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82498 0
Dr Melinda Jackson
Address 82498 0
Turner Institute for Brain and Mental Health
Sleep and Circadian Rhythms
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, VIC, 3800
Country 82498 0
Australia
Phone 82498 0
+61399050206
Fax 82498 0
Email 82498 0
[email protected]
Contact person for public queries
Name 82499 0
Dr Marina Cavuoto
Address 82499 0
Institute for Breathing and Sleep, Austin Health
Level 5, Harold Stokes Building, Austin Hospital
PO Box 5555, Heidelberg, Victoria, 3084
Country 82499 0
Australia
Phone 82499 0
+613 9496 3517
Fax 82499 0
Email 82499 0
[email protected]
Contact person for scientific queries
Name 82500 0
Dr Melinda Jackson
Address 82500 0
Turner Institute for Brain and Mental Health
Sleep and Circadian Rhythms
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, VIC, 3800
Country 82500 0
Australia
Phone 82500 0
+61399050206
Fax 82500 0
Email 82500 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
n/a


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.